Appendix C

Technology Assessment Report, Negative Pressure Wound Therapy Devices

Technology assessment on negative pressure wound therapy devices.

Appendix C: Evidence Tables

Key Question 1

Table 16. Comparison Trials of NPWT Devices Used to Treat Chronic Wounds

Reference	Wound Type	Comparator	Number of Patients Enrolled	Quality Score*
Blume et al. 2008 (108)	Diabetic Foot Ulcer	Advanced Moist Wound Therapy (AMWT)	342	Moderate
Armstrong et al. 2007 (109)	Diabetic Foot Ulcer	Standard wound therapy (SWT)	162	Moderate
Lavery et al. 2007 (341)	Diabetic Foot Ulcer	Wet-to-moist	1,721	Low
McCallon et al. 2000 (120)	Diabetic Foot Ulcer	Saline-moistened gauze	10	Low
Schwien et al. 2005 (126)	Pressure Ulcer	Any other wound care modality	2,348	Low
Wanner et al. 2003 (118)	Pressure Ulcer	Gauze soaked with Ringer's solution	22	Low
Ford et al. 2002 (110)	Pressure Ulcer	Healthpoint System (HP)	28	Moderate
Joseph et al. 2000 (113)	Pressure Ulcer	Saline wet-to-moist	24	Moderate
Denzinger et al. 2007 (135)	Complex Inguinal	Saline moistened gauze	16	Low
Moues et al. 2007 (136)	Full-thickness	Standard moistened gauze	54	Low
Siegel et al. 2007(119)	Radiation-associated	Standard of care	41	Low
Braakenburg et al. 2006 (114)	Chronic and acute	Hydrocolloid dressings, alginates, acetic acid or Eusol (sodium hypochlorite)	65	Moderate
Bickels et al. 2005 (134)	Soft tissue defects	Standard of care	38	Low
Page et al. 2004 (1)	Open foot	Standard of care	47	Low

* ECRI Institute study quality assessment instrument

Diabetic Foot Ulcers: The quality of the studies of diabetic foot ulcers was moderate (2 studies) and low (2 studies). Methodological study flaws included lack of appropriate randomization, high attrition and funding from a potentially biased source. Of the four studies, only one study indicated an appropriate randomization method. This study, however, reported the highest attrition rate of over 30% of the patient population.(108) One low-quality study,(120) reported ‘flip of a coin' followed by an alternate allocation as a randomization method. Finally, all of the studies were funded by one manufacturer which increases the potential for bias in reporting of results.

All four studies evaluated V.A.C.® (KCI, USA Inc.) a powered suction pump system, for the treatment of diabetic foot ulcers; one study evaluated diabetic foot amputation wounds. (Table 23). Comparator treatment for two studies was moistened gauze.(120,341) Two other studies assessed advanced moist wound therapy (hydrogels, hydrocolloids and alginates).(108-109) Patients averaged 58 years of age; average duration of ulcers was over 200 days. Complete patient and wound characteristics are presented in Table 24.

V.A.C.® foam dressings were changed every 48 hours as per the manufacturer's recommendations in three studies(108-109, 120) and control treatments were closely monitored with two studies adhering to standardized guidelines.(108-109) Wound measurements were assessed as frequently as every dressing change or up to 10 times in one 112-day study.(108) Treatment related characteristics are presented in Table 25.

Individual study results for four diabetic foot ulcer studies are presented in Table 26. Outcome reporting varied across studies but each study reported some measure of ulcer size reduction or time to complete wound healing. Small sample size (n = 10) precluded the determination of any statistically significant benefit in one low-quality study.(91) A 28.4% average decrease (V.A.C.®) and 9.5% average increase (control) was reported, however, one V.A.C.® (20%) wound increased in size and healed by ‘secondary intention.' Satisfactory healing was achieved in an average of 22.8 (±17.4) days for V.A.C.® and 42.8 (±32.5) days for control.

One moderate-quality study of 342 diabetic foot wounds;(108) reported a mean change in wound size in favor of NPWT (-4.32 cm² versus -2.53 cm², p = 0.021) as well as a higher proportion of V.A.C.®-treated patients achieving complete wound closure (43% vs. 28.9%). Data, however, were reported for day 28 during the ‘active treatment phase' although both 3 and 9 month follow-up assessments were completed for patients achieving ulcer closure. In addition, 40 patients (13% V.A.C.®) discontinued treatment due to adverse events (Table 6).

Armstrong et al.(109) reported results of a secondary analysis of a 16-week study of 164 diabetic foot amputation wounds. Results for this evaluation of wound chronicity indicated no significant difference for proportion of acute and chronic patients achieving complete wound closure or time to complete closure. In addition, there was no significant difference in the proportion of acute or chronic wounds that achieved complete closure between NPWT and SWT groups (acute P = 0.072, chronic P = 0.320). Lastly, a low-quality study by Lavery et al.(265) reported wounds healed at 12 and 20 week assessments with results favoring NPWT over standard of care (39.5% vs. 23.9%, week 12; 46.3% vs. 32.8%, week 20).

Pressure Ulcers: Quality of the four pressure ulcer studies was moderate (110, 113)) and low (118, 126). Of the four studies, three included small study populations ranging in size from 22 to 28 patients. One of two RCTs did not report randomization methods.(118) One study indicated that outcome assessors were blinded to treatment.(113) Studies did not indicate concealment of group allocation, and underreported patient characteristics which increases the likelihood that study patients were not comparable at baseline. All four studies either reported funding by one manufacturer or failed to report a conflict of interest.

Three studies strictly included only pressure ulcer wounds while one study involved patients with other types of wounds.(113) Comparator treatments included traditional and non-traditional treatments. Primary outcomes varied across studies and ranged from wound healing outcomes (i.e., change in wound volume) to quality of life issues (i.e., rates of hospitalization and emergent care). Two studies reported time to satisfactory wound healing(110, 118) while one study stated “complete wound closure was not a realistic end point since wounds were of variable sizes and anatomic locations.”(113)

Three studies showed a favorable effect in the group that received NPWT, however this was only significant in one study.(113) Results for one moderate-quality study included increased rates of wound healing, superiority in decreasing inflammation at the wound site, and increased number of capillaries (suggesting the promotion of formation of granulation tissue) compared to HealthPoint System.(110) In this 6 week study, complete healing was reported for only 4 wounds; 2 (10%; V.A.C.®) and 2 (13% HP).

A similar length study(113) evaluated 24 patients with 36 chronic non-healing wounds (79% pressure ulcers). Average initial wound volume was larger for V.A.C.® wounds (38 cubic centimeters (cc) vs 24cc) however a significant reduction in wound volume was still demonstrated (78% vs 30% control). A significantly greater reduction in wound depth (66% vs. 20% control; p 0.00001) and width was reported however improvement did not extrapolate to wound length.

One low-quality study evaluated 2348 patients (60 V.A.C.®) identified from a search of 1.94 million start-of-care assessments.(126) The purpose of this study was to determine whether NPWT was associated with positive quality outcomes. Instances of hospitalization for wound problems (5% versus 14%, control) and instances of emergent care for wound problems were lower (0% versus 8% control) for V.A.C.®. Ulcer size, treatment duration and treatment comparators were not indicated by study authors.

Wanner et al.(118) evaluated pressure ulcers of 22 paraplegics or tetraplegic patients. Authors concluded that gauze soaked with Ringer's solution was equally effective as NPWT in ‘time needed to form granulation tissue' (27 days vs. 28 days control).

Miscellaneous Chronic Wounds: Six studies included chronic wounds from miscellaneous diagnoses. Five of the studies were rated of low quality(112,119,134-136) and one was rated moderate.(114) Descriptions of study designs may be found in Table 19. Comparator treatments for five of the six trials were standard of care. Control treatment for the sixth study was ‘modern dressings' which includes hydrocolloid dressings, alginates, acetic acid or Eusol (sodium hypochlorite).(114) Table 20 and Table 21 list additional patient and treatment-related characteristics.

Three of the six studies reported a comparable benefit to time to satisfactory healing in comparison to control treatments.(1,114,136) One moderate-quality study, Braakenburg et al.(114), evaluated 65 patients with chronic and acute wounds. Similar results were reported for overall change in wound area (0.1cm²/day), time to satisfactory healing (median 16 (V.A.C.®) vs. 20 (control)) and overall change in the amount of granulation. Two patients discontinued V.A.C.® due to pain during dressing changes; one patient refused to cooperate (V.A.C.®); one amputation and 6 early dismissals were reported for control.

Moues et al.(136) reported similar ‘time to surgical readinesses' for 54 patients treated with V.A.C.® or SOC. Two V.A.C.® patients discontinued treatment due to sepsis of unknown origin. Two control patients registered wound surface area increase. Postoperative complications were high, reported in 32% of V.A.C.® and 43% of control groups (Table 5). Page et al.(1) reported no difference in ‘time to closure' and ‘wound cavity filling' for 47 patients with open foot wounds (Table 22).

Three remaining studies concluded that NPWT was more effective for time to wound closure than the control treatments.(119,134-135) Denzinger et al.(135) studied treatment of 16 complex inguinal wounds; 6 wounds treated with V.A.C.®. Median duration until complete wound closure was significantly shorter for V.A.C.® treated (38.9 days versus 69.8 days, control).

In one study of 41 patients with radiation-associated wounds, a significant improvement was reported for success of wound closure with the need for soft tissue transposition, hospital stay and length of overall treatment.(119) Mean change in wound area for V.A.C.® was reported at -329 cm³; however the authors failed to report data for the control group. Amputations were reported in both groups (V.A.C.® [1] and control [3]).

Bickels et al.(134) studied 62 patients with soft tissue defects. V.A.C.® patients had significantly greater rates of primary wound closure with or without skin graft; and significantly shorter hospital stays than non-V.A.C.® patients. Authors failed to report baseline wound size for controls. three control patients required lower extremity amputation.

Acute Wounds

The evidence base for comparison trials of NPWT used to treat acute wounds includes 16 low-quality studies (Table 17).

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Table 17. Comparison Trials of NPWT Used to Treat Acute Wounds

Reference	Wound Type	Comparator	Number of Patients Enrolled	Quality Score*
Timmers et al. 2009 (106)	Post-traumatic osteomyelitis	SOC	124	Low
Simek et al. 2008 (123)	Deep sternal	Conventional	62	Low
Yang et al. 2006 (72)	Fasciotomy	SOC	68	Low
Stannard et al. 2006 (125)	Study 1: hematoma	Study 1: Pressure dressing	Study 1: 44	Low
Stannard et al. 2006 (125)	Study 2: fracture	Study 2: Post-operative dressing	Study 2: 44	Low
Fuchs et al. 2005 (23)	Deep sternal	Conventional	68	Low
Immer et al. 2005 (130)	Deep sternal wound infection	Sternal excision and primary musculocutaneous flap	55	Low
Segers et al. 2005 (122)	Post-sternotomy mediastinitis (PM)	Closed drainage	63	Low
Sjogren et al. 2005 (139)	PM	Conventional	101	Low
Domkowski et al. 2003 (129)	PM	SOC	102	Low
Song et al. 2003 (124)	Surgical	Standard of care (SOC)	35	Low
Doss et al. 2002 (128)	Post-sternotomy osteomyelitis	SOC	42	Low
Catarino et al. 2000 (137)	PM	Closed drainage and irrigation	17	Low
Shilt et al. 2004 (138)	Traumatic	SOC	31	Low
Kamolz et al. 2003 (343)	Burn	Silver sulphadiazine	7	Low
Gabriel et al. 2008 (339)	Infected	SOC	30	Low
Ozturk et al. 2008 (117)	Fournier's gangrene	SOC	10	Low
Rinker et al. 2008 (121)	Open tibia fracture	SOC	55	Low
Huang et al. 2006 (127)	Limb	SOC	24	Low
Labler et al. 2004 (71)	Soft tissue	Epigard® dressing	23	Low

* ECRI Institute study quality assessment instrument

Surgical Wounds: The evidence base for studies evaluating NPWT treatment of sternal wounds (Table 31) included one randomized controlled trial and one retrospective review. Stannard et al.(125) evaluated two small study populations: (1) trauma patients with hematomas and (2) patients with high-risk fractures. Results for both studies included a significant difference in mean days to drainage favoring V.A.C.® (hematoma study: 1.6 days (d) versus 3.1; fracture study: 1.8 d versus 4.8). A higher infection rate for non-NPWT patients was reported in the hematoma study, while similar rates of infection and complications were reported in the fracture study.

The retrospective review by Song et al.(124) reported no significant differences for average days between debridement and definitive closure of the sternal wound (6 ±1.3 d versus 8 ±2.9 d, control). Results for all studies evaluating acute wounds can be found in Table 34.

Surgical Site Infections (SSI): Eight low-quality studies evaluated V.A.C.® for the treatment of surgical site infections (SSI). Interventions included conventional treatments (2 studies), closed drainage (3 studies), and standard of care (2 studies). Some studies reported similar results for wound healing(23,128,137,139), while two reported significant benefit(123) or modest benefit to NPWT.(122)

In a study of 62 patients with sternal wound infections, Simek et al.(123) reported significant findings for failure rate (5.8% versus 39.2%, control) and 1-year mortality (14.7% versus 39.2%, control) in favor of V.A.C.®.

In a similar-sized study, Fuchs et al.(23) retrospectively evaluated 68 patients and reported similar time to primary or secondary wound healing (21 days (IQR: 15 to 26d) versus 28 days (IQR: 18 to 54d), control). A total of 5 deaths occurred in this study; one death from vacuum-related perforation.

Segers et al.(122) evaluated 63 post-sternotomy (PM) patients treated by V.A.C.® or closed drainage technique (CDT). Duration of therapy (22.8 days versus 16.5, NS) and mean SSI hospital stay (46.1 versus 35.7) were longer with V.A.C.®. A high morbidity rate was reported (29%) with 9 deaths reported in each patient group. Mortality caused by SSI was lower for V.A.C.® (4 (13.8%) versus control (7 (20.6%). Go to Table 8 for a further description of acute study complications.

Sjogren et al.(139) examined 101 PM patients treated by V.A.C.® or conventional treatment which included open dressings, closed irrigation, pectoral muscle flaps, or omentum flaps. 61 patients underwent V.A.C.® as a single-line therapy followed by sternal rewiring. Results were similar for treatment duration, length of stay, and rate of infection, however, overall survival was significantly better in the V.A.C.® (97% versus 84% (6 months), 93% versus 82% (1 year), and 83% versus 59% (5 years).

Standard of care was evaluated as a comparator treatment for two studies evaluating treatment of SSI. In a study of 102 PM patients, Domkowski et al.(129) reported four deaths overall (2 from multisystem organ failure and 2 from overwhelming sepsis). Doss et al.(128) reported similar results for reduction in wound size (4.63 cm²/day versus 3.2 cm², control) and mortality (1 in each group) in a study of 42 PM patients.

A smaller study of 17 PM patients(137) reported similar time to wound closure (11 d median versus 13 d) although a significantly higher treatment failure for patients treated with closed drainage and irrigation (0 versus 5, control). Go to Table 32 and Table 33 for additional information on patient and treatment characteristics, respectively.

Lastly, Immer et al.(130) assessed 55 patients with deep sternal wound infections (DSWI) after cardiac surgery. Study population was divided into three groups: (1) NPWT (2) NPWT plus secondary sternal excision and musculocutaneous flap and (3) sternal excision and primary musculocutaneous flap. Survival was significantly better in Group 1 (NPWT only) who also scored significantly higher on a quality-of-life assessment, SF-36, for aspects of physical function, general health and vitality.

Traumatic Wounds: In 2004, Shilt et al.(138) examined 31 pediatric patients for treatment of lawnmower injuries. Length of hospital stay was longer in V.A.C.® treated (16.8 versus 10.2, control). Similar results were reported when a questionnaire (Vosburgh et al.), was administered to evaluate post-treatment functional outcomes (23.0 versus 22.6, control).

Standard of care was compared to V.A.C.® in one low-quality study.(72) Yang et al. compared 68 patients with fasciotomy wounds for traumatic compartment syndrome. Results indicated a significant reduction in overall time to definitive wound closure by either delayed primary closure with sutures or STSG for V.A.C.®-treated (6.7 days versus 16.1 days, p = 0.0001).

Timmers et al.(106) recently assessed treatment of 124 post-traumatic osteomyelitis patients by negative pressure instillation therapy (NPIT) versus SOC. The median duration of the first hospital stay did not differ (36 days (V.A.C.®) vs. 27.3 days), however due to the high number of recurrences of osteomyelitis (58.5%) and subsequent rehospitalizations, the cumulative duration of hospital stay was significantly higher in the control group (73 days versus 36 days (V.A.C.®) (p < 0.0001).

Burn Wounds: One low-quality study examined treatment of burn wounds for 7 patients (used as their own controls).(343) Wounds with more intense injury received V.A.C.® while the other less injured hand received silver sulphadiazine (SSD) crème. Results indicate a greater reduction of edema formation within the V.A.C.® treated hand.

Miscellaneous Acute Wounds: Traditional treatments were compared to V.A.C.® in five low-quality studies examining miscellaneous acute wound.(71,117,121,127,263) Results were similar for two(117,127, 339) Results were similar for two(117,127) while three studies found benefit from V.A.C.® treatment.(71,121,339)

A subgroup of 55 sub-acute patients underwent a free muscle flap for treatment of a Gustilo grade IIIB or IIIC tibia fracture(121) (overall n = 105). Time to bony union was significantly less for V.A.C.® treated (4.9 months versus 7.2 months). Length of hospital stay was similar (20.8 ±10.5 versus 20.2 ±8.5, control).

Gabriel et al.(339) evaluated 30 patients with infected trunk and extremity wounds treated with NPWT with instillation. NPWT patients (n = 15) experienced significantly fewer days to wound closure (13.20 ±6.75 versus 29.6 ±6.54, control) and significantly shorter days to patient discharge (14.67±9.18 versus 39.2 ±12.07, control). 100% of wounds were healed with NPWT with instillation versus 66.7% of the traditional group.

In 2004, Labler et al.(71) compared 23 patients with severe open fractures treated by V.A.C.® or Epigard® dressing. Wounds were ‘healed uneventfully' for 11 of 13 (85%) V.A.C.® versus five of ten (50%) control wounds. Rate of infection was higher for Epigard® treated (6 of 11 (55%) versus 2 of 13 (15%), V.A.C.®).

In a small study (n = 10) of patients with Fournier's gangrene, similar results were shown for ‘time to satisfactory healing' (9 days vs 10d (control); and ‘hospital stay'(14 days vs 13 days (control).(117) Pain assessment measured by the visual analog scale (VAS) indicated less pain in V.A.C.® group (2.4 and 6.8, control). Patients scored need for analgesics, number of times per day mobile, and number of additional dressing changes per day.

Results for hospital stay and wound volume were similar in a study of 24 patients with limb wounds.(127) Mean days for hospital stay (32.1d vs. 34.3) and reduction in dimension (47% vs. 41% control) and reduction in volume (49% vs. 39% (control)) were all similar for V.A.C.® and control groups. Adverse events resulting in discontinuation of treatment included 1 death and 2 amputations in V.A.C.® (25% of group). One death and two amputations were reported in SOC group as well.

Skin Graft. The evidence base for comparison trials of NPWT devices used to secure skin grafts includes two moderate-quality and five low-quality studies (Table 18).

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Table 18. Comparison Trials of NPWT Devices Used to Secure Skin Graft

Reference	Wound Type	Comparator	Number of Patients Enrolled	Quality Score*
Korber et al. 2008 (340)	Chronic leg	Standard of care (SOC)	54	Low
Vuerstaek et al. 2006 (111)	Chronic leg	Conventional (hydrocolloids, alginates)	60	Moderate
Vidrine et al. 2005 (342)	Skin grafted radial forearm	Bolster dressing plus splint	44	Low
Moisidis et al. 2004 (112)	Clinically ready for skin graft	Bolster dressing	22	Moderate
Stone et al. 2004 (133)	STSG	Cotton bolster dressing	40	Low
Scherer et al. 2002 (132)	STSG	Cotton bolster dressing	61	Low
Genecov et al. 1998 (131)	STSG	Opsite	10	Low

* ECRI Institute study quality assessment instrument
STSG = Split thickness skin graft

Seven studies evaluated the use of NPWT to secure skin grafts (split-thickness, mesh and punch). Quality of the studies was moderate (k = 2) and low (k = 5). Comparators included bolster dressings (k = 4), standard of care (k = 1), Opsite dressing (k = 1) and conventional treatments (i.e., hydrocolloids, alginates) (k = 1). Study populations were small, ranging from 10 to 61 patients (Table 27).

Two moderate-quality studies randomized patients to NPWT or conventional and bolster dressings.(112,115) Vuerstaek et al.(115) evaluated 60 patients with chronic leg ulcers randomized to treatment by V.A.C.® or alginates/hydrocolloids. Time to complete healing was significantly reduced in the NPWT group (29 d (95% CI, 25.5 to 32.5) versus 45 d(95%CI, 36.2 to 53.8)). Results for secondary outcomes included a greater relapse at 1 year follow-up (52% of all healed V.A.C.® ulcers relapsed compared with 42%, control). Both groups reported significant increases in quality of life and similar decreases in pain. Go to Table 30 for further details on measures of outcome.

Moisidis et al.(112) enrolled 22 patients (used as their own controls) with wounds clinically ready for skin graft. Total negative pressure (TNP) was used on the superior half of the wound in ten patients and inferior half in the remaining ten. At 2 weeks, a quantitative assessment by a clinician blinded to treatment reported the degree of epithelialization similar in both groups.

One low-quality study(340) evaluated 54 patients with 74 chronic leg ulcers of comparable size (Table 28). Complete healing of mesh grafts was significantly higher for V.A.C.® treated compared to standard of care (92.9% versus 67.4%). Age older than 70 years, diabetes mellitus and dermatoliposclerosis were strong predictors to poor graft take.

Three low-quality studies evaluated a bolster dressing as a comparator treatment. A four week assessment of 45 radial forearm donor sites indicated overall complete split-thickness skin graft (STSG) take rate higher in negative pressure dressing group compared to management by bolster dressing and splint.(342) Stone et al.(133) evaluated 40 trauma patients who received 46 STSGs. Similar results were reported for duration of dressing (4.8d versus 5.2d, control), mean hospital stay (20.9 ±10 versus 15.3 ±7.5, control), and graft failure. No grafts failed in the NPWT group while one graft failure was reported in the control group (Table 7).

Improved graft survival was reported by Scherer et al.(132) in an assessment of graft take placed for burn (52%), soft tissue loss (44%) and fasciotomy-site coverage (3%). Repeated STSG to same site was significantly higher in controls compared to V.A.C.® (5 (19%) versus 1 (3%)). Although grafts were significantly larger in the control group (984 ±996 cm² versus 387±573 cm²) the 6 repeated grafts were of small or moderate size.

In a seven day study, Genecov et al.(131) evaluated 10 patients who served as their own controls. Blinded assessors analyzed biopsies to measure degree of reepithelialization (Table 29). Results indicated faster reepithelialization with V.A.C.® (n = 7); no difference (n = 2); and more rapid reepithelialization with Opsite (n = 1).

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Table 19. Key Study Design Characteristics of Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic Wounds

Reference	Study Type	Wound Type	Number of Patients Enrolled	Comparison Treatment	Inclusion Criteria	Exclusion Criteria	Length of Study	Attrition
Moues et al. 2007 (136)	RCT*	Full-thickness	54	Standard moist gauze	From July 1998 to October 2002, patients with a full-thickness wound that could not be closed immediately because of severely crushed tissue, infection or chronic character	Malignant disease, superficial bare blood vessels, deep fistulas, necrotic tissue, an unstable skin around the wound, sepsis, untreated Osteomyelitis, active bleeding, uncontrolled diabetes and psychiatric disorders	Ready for surgical readiness	V.A.C.®—3 Control—2
Braakenburg et al. 2006 (114)	RCT*	Acute and chronic	65	Conventional therapy Hydrocolloid dressings, alginate, acetic acid, or Eusol (sodium hypochlorite)	Consecutive patients with any type of wound, acute or chronic, throughout all patient departments at the Rijnstate Hospital, Arnhem, The Netherlands between March 2002 and May 2004.	Steroid drugs, residual malignant cells in the wound, radiotherapy, deep fistulas, sepsis, underlying osteomyelitis, active bleeding, patients younger than 18 years, and psychiatric patients.	Complete granulated wound or a wound ready for skin grafting or healing by secondary intention	NR
Denzinger et al. 2007 (135)	Non-RCT*	Inguinal wounds	16	Saline-moistened gauze	Patients with inguinal regions subjected to lymphadenectomy for penile cancer between 2000 and 2006.	NR	Complete wound closure	NR
Siegel et al. 2007 (119)	Non-RCT*	Radiation-associated	41	SOC	NPWT: 22 patients treated with V.A.C.® between Jan 2003 and Jan 2006 with soft tissue sarcomas treated with both surgical intervention and radiation therapy and developed either superficial or deep wound (16) complications: SOC: 19 patients with soft tissue sarcomas treated from Jan 2001 and Jan 2003 with similar history of radiation treatment, chemotherapy, wound size and patient age	NR	Until wound healing by either primary or secondary intention, skin grafting or soft tissue transposition	NR
Bickels et al. 2005 (134)	Non-RCT*	Soft tissue defects	62	SOC	V.A.C.®: 23 consecutive patients with large defects after tumor resection treated in 2002 and 2003. Control: 39 patients with similar defects treated between May 1999 and May 2002	Patients with gross infection or residual tumor at the surgical site were excluded from V.A.C.®	Wound is covered with viable and thick granulation tissue allowing for primary closure, skin grafting or healing by secondary intention F/U 12—27 months (median 19 months)	NR
Page et al. 2004 (1)	Non-RCT*	Open foot	47	Saline-soaked gauze	Patients identified in a surgical log at Carl Hayden VA Medical Center aged 18 to 75 with an open foot wound of any etiology requiring surgical intervention, no presence of infection in the wound when therapy was initiated, a soft tissue defect at least 2 cm deep following surgical intervention (debridement/amputation) and wound treatment with either NPWT or wet-to-moist dressings after surgical intervention	Persistent wound infection, necrotic tissue in the wound bed, and interruption in treatment or use of alternative therapies during the wound cavity filling time	NR	NR

NR = Not Reported
RCT = Randomized controlled trial
* All studies reported using V.A.C.® (KCI, USA Inc.)

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Table 20. Patient Characteristics in Comparison Studies of NPWT Devices Used to Treat Miscellaneous Chronic Wounds

Reference	Study Type	Number of Patients	Mean (SD) Age (years)	Sex	Comorbidities	Number of Wounds	Mean (SD) Baseline Wound Area (cm²) or Volume (cm³)	Severity of Wounds	Mean (SD) Duration of Ulcer
Moues et al.(136)	RCT	V.A.C.®: 29	47.7 ±19.6	NR	Diabetes—6 Vascular compromised—8 Osteomyelitis—8	29	NR	12 early treated, 17 late treated	NR
	RCT	Standard moist: 25	47.9 ±17.0	NR	Diabetes—6 Vascular compromised—8 Osteomyelitis—8	29	NR	12 early treated, 17 late treated	NR
	RCT	Standard moist: 25	47.9 ±17.0	NR	Diabetes—1 Vascular—3 Osteomyelitis—4 Spinal cord lesion—5	25		8 early treated, 17 late treated
Braakenburg et al.(114)	RCT	V.A.C.®: 32	65.5 median	M20 F12	Diabetes—12 (37%) Vascular surgery—9 (28%) Cardiovascular disease—11 (34%) Smoking—8 (29%)	32	29.5 cm² (median) Range: 3 to 600 cm²	Chronic—64% Acute—11% Subacute—23	NR
Braakenburg et al.(114)	RCT	Control: 33	69.2 median	M16 F17	NR	33	30 cm² (median) Range: 6 to 152 cm²	NR	NR
Denzinger et al.(135)	Non-RCT	V.A.C.®: 5	64	M5	No difference reported	6	34 cc Range: 24-54	NR	NR
Denzinger et al.(135)	Non-RCT	SOC: 9	67	M9	No difference reported	10	37 cc Range: 24-84
Siegel et al.(119)	Non-RCT	V.A.C.®: 22	41 (24-78)	NR	NR	22	111 cm³ Range: 2.5-3,660	NR	NR
Siegel et al.(119)	Non-RCT	SOC: 19	46 (19-67)		NR	19	410 cm³ Range: 4-3,800 cm³	NR	NR
Bickels et al.(134)	Non-RCT	V.A.C.®: 23	Median: 46.5 Range: 36-72	M8 F15	NR	23	Mean: 345 cm² Range: 64 cm² to 520 cm²	NR	NR
Bickels et al.(134)	Non-RCT	SOC: 39		M21 F18	NR	NR	NR	NR	NR
Page et al.(1)	Non-RCT	V.A.C.®: 22	66 (±12)	M22	Diabetes—17 (77%)	22	Wound dimensions were not consistently recorded Wounds were divided into small, medium and large Small 2 (9%) Med 6 (27%) Lg 14 (64%)	NR	NR
Page et al.(1)	Non-RCT	Control: 25	60 (±11)	M25	Diabetes—14 (56%)	25	Small 8 (32) Med 7 (28%) Lg 10 (40%)

RCT = Randomized controlled trial

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Table 21. Treatment-Related Characteristics in Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic Wounds

Reference	Study Type	Treatments	Treatment Change	Wound Assessment	Frequency of Measurements	Treatment Duration	Prior Treatments	Concurrent Treatments
Moues et al. (136)	RCT	V.A.C.® Continuous pressure of 125 mmHg Polyurethane foam dressing with a pore size of 400-600 um (V.A.C.® pack)	48 hrs	Trace of wound onto clear polyethylene film; after photocopying the tracing onto paper, the wound surface areas were scanned and calculated; tissue biopsies taken every 2-3d throughout treatment	Every 48 hrs	Ready for surgical readiness or 30 days or prior to 30 days if treatment terminated	NR	Initially, surgical debridement: V.A.C.® 97%, control 88% Secondly, surgical debridement: 4 V.A.C.®, 3 control Thirdly, chemical debridement was clinically indicated in 20 out of 25 control wounds (80%) Topical antimicrobial treatment used for 11 out of 25 control wounds (44%) Special pressure relieving mattresses if bedridden
Moues et al. (136)	RCT	Standard moist- saturated in either 0.9% saline, 0.2% nitrofuralam, 1% acetic acid or 2% sodium hypochlorite	2x/day minimum		Every 48 hrs		NR
Braakenburg et al.(114)	RCT	V.A.C.® CNP: -125 mmHg Black polyurethane foam dressing with a pore size of 400 to 600 um	3x/wk	Photos and bacteriologic swabs—1x/wk Wound surface measured with a standardized drape—2x/wk Pain assessed with visual analogue scale—3x/wk	3x/wk	NR	NR	Surgical debridement
Braakenburg et al.(114)	RCT	Conventional	1 or more times/day		3x/wk	NR	NR	Surgical debridement
Denzinger et al.(135)	Non-RCT	V.A.C.® Continuous negative pressure (125 mmHg) Foam dressing	Every 3d	NR	NR	Complete wound closure	Inguinal lymphadenectomy for penile cancer	Surgical debridement Secondary surgical debridement Adjuvant radiotherapy or chemotherapy: 2 V.A.C.® and 3 SOC
Denzinger et al.(135)	Non-RCT	SOC + hydrogel (n = 3) + hydrocolloid (n = 2)	Every other day	NR	NR	Complete wound closure	Inguinal lymphadenectomy for penile cancer
Siegel et al.(119)	Non-RCT	V.A.C.® Continuous 125 mmHg Sponge	Every 2-3d	NR	NR	Average: 41d over a 3 year period	Surgical resection and radiation	Surgical debridement Post-operative brachytherapy Rotational soft tissue transposition (n = 6) Free vascularized flap (n = 1) Split thickness skin graft (n = 8)
Siegel et al.(119)	Non-RCT	SOC and/or additional soft tissue coverage procedures					Surgical resection and radiation
Bickels et al.(134)	Non-RCT	V.A.C.® Continuous negative pressure: -125 mmHg Polyurethane foam dressing	48 hours for 7 to 19 days	NR	NR	When wound is covered with viable and thick granulation tissue, which allows primary closure, skin grafting, or healing by secondary intention Average 14.5d Range: (7 19d) Average: 9.5d for patients who did not have radiation (n = 7) or exposed bone or tendon (n = 6)	Chemotherapy—9 Radiation—7	Surgical debridement Skin graft—14 Healing by secondary intention—2
Bickels et al.(134)	Non-RCT	SOC	Daily	NR	NR	NR	NR	Surgical debridement (second surgical debridement for 24 patients) Skin graft—10 Free flap transfer—3 Healing by secondary intention—15 Lower extremity amputation—3
Page et al.(1)	Non-RCT	V.A.C.®	NR	NR	NR	NR	NR	NR
		Saline moistened gauze	NR	NR	NR	NR	NR	NR

NR = Not Reported
RCT = Randomized controlled trial
* All studies reported using V.A.C.® (KCI, USA Inc.)

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Table 22. Results for Outcome Measures Reported in Comparison Studies of NPWT Devices^* Used to Treat Miscellaneous Chronic Wounds

Reference	Study Type	Treatments	N	Wounds Healed	Mean (SD) Change in Wound Area (cm²) or Volume (cm³)	Satisfactory Healing	Other Important Outcomes	Adverse Events Resulting in Discontinuation of Treatment
Moues et al. (136)	RCT	V.A.C.®	29		3.8 ±0.5%/day (n = 15; reduction observed in 100%) Subgroup	Time to surgical readiness: 6.00 ±0.52 days	NR	2 (sepsis with unknown origin, ischaemic pain with increased tissue necrosis)
Moues et al. (136)	RCT	Standard moist	25		1.7 ±0.6%/day (n = 13; reduction observed in 77%)	7.00 ±0.81d
Braakenburg et al. (114)	RCT	V.A.C.®	32	26	Overall change: 0.1 cm²/day	Median time in days (95% CI): 16 (9-23)	Overall change in the amount of granulation was not different between the two groups.	2 (due to pain during dressing changes)
Braakenburg et al. (114)	RCT	Conventional	33	21	Overall change: 0.1 cm²/day	Median time in days (95% CI): 20 (16-24)
Denzinger et al. (135)	Non-RCT	V.A.C.®	5	6	NR	38.9d (median)	Hospital stay: 13.2d (8-27)	NR
Denzinger et al. (135)	Non-RCT	SOC	9	10	NR	69.8d	28.4 (16-39)	NR
Siegel et al. (119)	Non-RCT	V.A.C.®	22	21	-329 cm3	Split thickness graft—8 Soft tissue transposition—6 Free vascularized flap—1 Primary closure—2 Secondary intention—4 Healed post-amputation—1	Hospital stay: 3.1d (portable V.A.C.®) 41d (1 patient in hospital)	NR
Siegel et al. (119)	Non-RCT	SOC			NR	Split thickness graft—3 Rotational flaps—7 Free vascularized flap—4 Secondary intention—5	42d
Bickels et al. (134)	Non-RCT	V.A.C.®	23	23 (covered with viable)	Average 25% reduction (range, 10% 35%): 20 patients Wounds from 3 patients showed no reduction in size (2 soft tissue around leg and 1 sacral)	NR	Hospital stay: 4-30d (Mean: 18.5; Median: 20d)	NR
Bickels et al. (134)	Non-RCT	SOC	39	39	NR		Hospital stay: 15-72d (Mean: 37d; Median: 39d)
Page et al. (1)	Non-RCT	V.A.C.®	22	NR	Median time of wound filling: 38d (95% CI: 26 to 70)	NR	Median time to closure: 110d (79,184)	NR
Page et al. (1)	Non-RCT	SOC	25		80d (95% CI: 55 to 98) Wilcoxon chi-square suggests a difference between groups during the earlier part of follow-up (p = 0.040); the likelihood ratio chi-square indicates no overall difference in wound cavity filling time between groups (p = 0.41)		124d (105,284) No difference in time to closure between groups (Wilcoxon chi square, P = 0.29

NR = Not reported
RCT = Randomized controlled trial
SOC = Standard of care
VAS = Visual analogue scale

^* All studies reported using V.A.C.® (KCI, USA Inc.)

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Table 23. Study Design Characteristics of Comparison Studies of NPWT Devices^* Used to Treat Diabetic Foot and Pressure Ulcers

Reference	Study Type	Wound Type	Number of Patients Enrolled	Comparison Treatment	Inclusion Criteria	Exclusion Criteria	Length of Study	Attrition
Blume et al. 2008 (108)	RCT^*	Diabetic foot ulcers (DFU)	342	Advanced moist wound therapy (AMWT) AMWT: Hydrogel 47% Alginates 31% Other 16.9% Saline 10.2% Collagen 6.6% Hydrocolloid 0.6%	Diabetic adults ≥ 18 years with a stage 2 or 3 (Wagner's scale) calcaneal, dorsal, or plantar foot ulcer ≥ 2 cm² in area after debridement	Recognized active Charcot disease or ulcers resulting from electrical, chemical, or radiation burns and those with collagen vascular disease, ulcer malignancy, untreated osteomyelitis, or cellulitis; uncontrolled hyperglycemia (A1C >12%) or inadequate lower extremity perfusion; ulcer treatment with normothermic or hyperbaric oxygen therapy; concomitant medications such as corticosteroids, immunosuppressive medications or autologous growth factor products; skin and dermal substitutes within 30 days of study start; or use of any enzymatic debridement treatments; pregnant or nursing mothers.	Incidence of complete ulcer closure or 112d	NPWT: n = 55 1 lost to f/u 54 discontinued AMWT: n = 48 5 lost to f/u 43 discontinued
Armstrong et al. 2007 (109)	RCT^*	Diabetic foot amputation	162	Standard wound therapy (SWT) SWT: Alginates Hydrocolloids Foams Hydrogel	Individuals aged ≥18 years, presence of a diabetic foot amputation wound up to the tarso-metatarsal level of the foot and evidence of adequate perfusion.	Active Charcot arthropathy of the foot, wounds resulting from burns or venous insufficiency; patients presenting with untreated cellulitis or osteomyelitis (following amputation), collagen vascular disease, malignancy in the wound or uncontrolled hyperglycaemia; treated with corticosteroids, immunosuppressive medications or chemotherapy; treated with V.A.C.® within the past 30 days, present or previous treatment with growth factors, normothermic therapy, hyperbaric medicine or bioengineered tissue products within the past 30 days.	Until wound closure or 112 days	19 NPWT and 19 SWT withdrew before wound closure
Wanner et al. 2003 (118)	RCT^*	Pressure sores of the pelvic region	22	Gauze soaked with Ringer's solution	Consecutive patients with pressure sores (deeper than grade 2 as described by Daniel et al.) of the pelvic region admitted to the Swiss Paraplegic Centre, Nottwil, Switzerland between January 1998 and May 1999. Patient population consisted of paraplegics or tetraplegics.	NR	NR	NR
Ford et al. 2002 (110)	RCT^*	Full-thickness decubitus ulcers	28	Healthpoint System (HP)	Patients recruited from the plastic surgery clinic and inpatient referral at Boston Medical Center with one to three full-thickness ulcers present for a minimum of 4 weeks; albumin ≥2.0; age 21-80; ulcer volume after debridement = 10 150 ml	Fistulas to organs or body cavities, malignancy in the wound, pregnant or lactating female, Hashimoto's thyroiditis, Graves' disease, iodine allergy, systemic sepsis, electrical burn, radiation exposure, chemical exposure, cancer, connective tissue disease, chronic renal or pulmonary disease, uncontrolled diabetes, corticosteroids or immunosuppressive agents, cardiac pacemaker, ferromagnetic clamps, recent placement of orthopedic hardware	6 weeks	6
Joseph et al. 2000 (113)	RCT*	Chronic non-healing	24	Saline wet-to-moist (WM) dressings	Patients with chronic non-healing wounds defined as an open wound in any anatomic location that had failed to close or show signs of healing within four weeks or greater; enrolled between January 1998-May 1999 at Boston Medical Center	Infection (urinary tract, pneumonia, wound infection); albumin <3.0 gm/dl; renal, pulmonary, or other chronic disease requiring ongoing therapy for stabilization; uncontrolled diabetes mellitus, thyroid disease, or hypertension; systemic steroids, other immunosuppressive therapy or anticoagulants; pregnant or breast feeding; Osteomyelitis as determined by bone biopsy; uncooperative or unsuitable candidates for participation in dressing changes; malignant or neoplastic diseases in wound margin; fistulas	6 weeks	NR
Lavery et al. 2007 (341)	Non-RCT*	Diabetic Foot Ulcer	1,721	Wet-to-moist	NPWT: Data from a proprietary database maintained by KCI from patients treated for wound care between 1996 and 2004; presence of wound categorized as diabetic/ulcer neuropathic ulcer, wound treated with NPWT, wound of chronic nature, debridement of necrotic tissue performed, comprehensive diabetes management included with the case plan, reduction in pressure of affected ulcer, as needed and description of the wound size and duration prior to NPWT. Control: Patients from 5 RCTs published between 1992 and 1998 and included in a meta-analysis by Margolis et al.; chronic wounds categorized as diabetic/neuropathic ulcers, appropriate offloading, as needed, the presence of adequate perfusion, infection control (if present) and debridement of necrotic tissue.	NPWT: If untreated osteomyelitis or cancer was present within the wound, if there was no record of treatment termination or no reason was given for treatment termination, or if multiple treatment termination entries were present.	NPWT: If closure through secondary intention or through a surgical intervention or if adequate granulation for closure by these methods was documented. Control: Wound was completely healed.	NR
Schwien et al. 2005 (126)	Non-RCT*	Pressure Ulcer	2,348 (60 V.A.C.)	Any other wound care modality	Data from 1.94 million OASIS start-of-care assessments; start of care and end of care between July 1, 2002 and September 30, 2004; One stage III or one Stage IV pressure ulcer; primary diagnosis of 707.0 decubitus chronic skin ulcer	Patients who died at home; enteral or parenteral nutrition therapy; high risk factors or heavy smoking, alcohol dependency, or drug dependency; poor or unknown overall prognosis; secondary diagnosis of uncontrolled diabetes, cancer, systemic infections, or related to malnutrition/anemias/proteinemia	NR	NR
McCallon et al. 2000 (120)	Non-RCT*	Diabetic Foot	10	Saline-moistened gauze	Patients selected from the Diabetic Foot Clinic at Louisiana State University Health Science Center aged 18 to 75 years of age with a non-healing foot ulceration which had been present for longer than 1 month	Patients presenting with venous disease, patients with active infections not resolved by initial debridement; and patients with coagulopathy	Until satisfactory healing	NR

NR = Not reported
RCT = Randomized controlled trial

* All studies reported using V.A.C.® (KCI, USA Inc.)

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Table 24. Patient Characteristics in Comparison Studies of NPWT Devices^* Used to Treat Ulcers Diabetic Foot and Pressure Ulcers

Reference	Study Type	Number of patients	Mean (SD) Age (years)	Sex	Comorbidities	Number of Wounds	Mean (SD) Baseline Wound Area (cm²) or Volume (cm³)	Severity of Wounds	Mean (SD) Duration of Ulcer
Blume et al. (108)	RCT	V.A.C.®: 172	58 ±12	M 141 F 28	Smoker: 34 Uses alcohol: 37 Diabetes (type1): 15 Diabetes (type2): 154	169	13.5 ±18.2	NR	198.3 ±323.5d
Blume et al. (108)	RCT	Advanced Moist Wound Therapy: 169	59 ±12	M 122 F 44	Smoker: 32 Uses alcohol: 45 Diabetes (type1): 14 Diabetes (type2): 152	166	11.0 ±12.7		206.0 ±365.9d
Armstrong et al. (109)	RCT	77 V.A.C.®	57.2 ±13.4^** 56 ±12.3 65 ±12.2	M 66^* F 11	Diabetes, alcohol and tobacco use	63 acute 14 chronic	22.8 ±21.0 14.1 ±17.9	Acute and chronic	Acute 0.4 (0.22) months Chronic 5.0 (9.3) months
Armstrong et al. (109)	RCT	85 Standard Wound Therapy	60.1 ±12.2^* 56 ±12.3 65 ±12.2	M 66^* F 19	Diabetes, alcohol and tobacco use	59 acute 26 chronic	22.8 ±21.0 14.1 ±17.9	Acute and chronic	Acute 0.4 (0.22) months Chronic 5.0 (9.3) months
Wanner et al. (118)	RCT	11 V.A.C.®	49 (25-73)	7 M 4 F	Vascular disorders—0 Zinc depletion—5 Hypoalbuminaemia—3 Hypoproteinaemia—5 Anemia—8 Nicotine—3	11	50 (33) Wound volume (ml) Range: 3-132	Deeper than Grade 2 (at least a penetration in the subcutaneous fat)	NR
Wanner et al. (118)	RCT	11 gauze soaked with Ringer's	53 (34-77)	8 M 3 F	Vascular disorders—2 Zinc depletion—5 Hypoalbuminaemia—1 Hypoproteinaemia—3 Anemia—5 Nicotine—2	11	42 (16) Wound volume (ml) Range: 5-68		NR
Ford et al. (110)	RCT	N = 22 V.A.C.®—NR	41.7 average	NR	NR	20	NR	Stage III or IV	NR
Ford et al. (110)	RCT	Healthpoint system—NR	54.4 average			15		Stage III or IV	NR
Joseph et al. (113)	RCT	N = 2411 V.A.C.® NR	56	M 66%	NR	18 Pressure—18 Dehiscence—1 Trauma—1 Venous insufficiency—2 Radiation—1	38 cm³	NR	NR
Joseph et al. (113)	RCT	Saline wet-to-moist: NR	49	M 44%		18 Pressure—14 Dehiscence—3 Trauma—1 Venous insufficiency—0 Radiation—0	24 cm³	NR	NR
Lavery et al. (341)	Non-RCT	V.A.C: 1,135	58.5 ±9.4	M 64.5%	NR	1,135	13.8 ±15.8	NR	26.5 ±24.7 (wks)
Lavery et al. (341)	Non-RCT	Wet-to-moist: 586	58	M 73.2%			1.61		30 (wks)
Schwien et al. (126)	Non-RCT	V.A.C.®: 60	65 ±18.27	M 28 F 32	Obesity—13 (22%) No. of secondary diagnosis—6 (10%) Diabetes as first secondary diagnosis—5 At least one secondary diagnosis—54	NR	NR	Stage III or IV	NR
Schwien et al. (126)	Non-RCT	Control: 2,288	71.4 ±18.14	M 961 F 1,327	Obesity—290 (13%) No. of secondary diagnosis—264 (12%) Diabetes as first secondary diagnosis—138 (6%) At least one secondary diagnosis—2,024	NR	NR	Stage III or IV	NR
McCallon et al. (120)	Non-RCT	V.A.C.®: 5	55.4 (±12.8)	NR	Hemoglobin, albumin, and blood glucose levels comparable at baseline	5	NR	Non-healing	NR
McCallon et al. (120)	Non-RCT	Control: 5	50.2 (±8.7)			5	NR	Non-healing	NR

NR = Not reported
RC = Randomized controlled trial

* All studies reported using V.A.C.® (KCI, USA Inc.)
** Patient characteristics retrieved from primary study (194)

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Table 25. Treatment-Related Characteristics in Comparison Studies of NPWT Devices^* Used to Treat Diabetic Foot and Pressure Ulcers

Reference	Study Type	Treatments (include type of NPWT dressing)	Treatment Change	Wound Assessment	Frequency of Measurements	Treatment Duration	Prior Treatments	Concurrent Treatments
Blume et al. (108)	RCT	V.A.C.® CNP: mmHg NR Foam dressing	Every 48-72 h No less than 3x/wk	Wound examination and tracings	Weekly for 4 weeks then every other week until day 112 or ulcer closure	Complete ulcer closure defined as skin closure (100% re epithelization) without drainage or dressing requirements OR day 112	Treated for ulcer infection prior to randomization: 50	Surgical debridement Standard off loading therapy Wounds for 9.5% of NPWT and 8.4% of AMWT-treated were later surgically closed by split thickness skin graft, flaps, sutures, or amputations
Blume et al. (108)	RCT	Advanced Moist Wound Therapy (AMWT)	As specified by Wound, Ostomy and Continence Nurses Society guidelines and institutional treatment protocols	Wound examination and tracings			Treated for ulcer infection prior to randomization: 45
Armstrong et al. (109)	RCT	V.A.C.® Foam dressing	Every 48 hrs	Digital photos and tracing	Days 0, 7, 14, 28, 42, 56, 84, and 112	Until wound closure (100% re-epithelialization without drainage) or until completion of 112 day period of assessment	NR	Off- loading therapy with a pressure relief walker or sandal Surgical debridement 31 NPWT and 25 SWT had complete wound closure without surgical closure 12 NPWT and 8 SWT had complete wound closure with surgical intervention 15 NPWT and 33 SWT completed active phase of study without complete wound closure
Armstrong et al. (109)	RCT	Standard Wound Therapy (SWT)	According to standardized guidelines	Digital photos and tracing	Days 0, 7, 14, 28, 42, 56, 84, and 112		NR
Wanner et al. (118)	RCT	V.A.C.® continuous at 125 mmHg Polyvinyl foam and transparent polyurethane dressing	Every 2-7 days	One wound assessor; volume was calculated by covering the ulcer with a transparent, elastic polymer (OpSite, Smith & Nephew). Sheet was punctured at the highest point and 0.9% saline solution was injected through a hypodermic needle until no air was left in the cavity. The injected volume was measured.	Every 7 days after initial measure in the operating room (value considered 100%)	Until wound volume had decreased by 50% (at which time the wound was closed with a flap)	NR	Surgical debridement Ulcers closed with a flap after study treatment
Wanner et al. (118)	RCT	Gauze soaked with Ringer's solution	3x/day until clean granulation tissue was observed. Then wound kept wet with Ringer's and dressing changed 1 3x/day				NR
Ford et al. (110)	RCT	V.A.C.®	Mon/Wed/Fri	At 3 weeks, a photograph of the wound site; a plaster wound impression; and measurement of wound dimensions. At 6 weeks, a series of post-treatment tests consisting of a photograph of wound site; a soft-tissue biopsy; a plaster wound impression; and measurement of wound dimensions. Repeat bone biopsy/ MRI if performed at pretest.	3 and 6 weeks	6 weeks (f/u ranged from 3-10 months)	Patients with osteomyelitis received a 6-week course of systemic antibiotics	Surgical debridement Strict pressure reduction with appropriate beds and positioning patients with 3 wounds underwent additional 6 week treatment of opposing treatment 6 wounds in the V.A.C.® group (30%) and 6 wounds in the HP group (40%) underwent flap surgery
Ford et al. (110)	RCT	HP	once or twice/daily
Joseph et al. (113)	RCT	V.A.C.® Pressure NR Open-cell foam dressing	Every 48 hours	Photography and measured by volume displacement of alginate impression molds	3 and 6 weeks or until wound closure	Complete wound closure not a realistic end point since wounds were of variable sizes and anatomic locations	All patients had previously failed multiple medical and surgical wound treatments. Two patients (V.A.C.®) previously had bypass grafting for revascularization. Both eventually required amputation.	Pressure-relieving surface Debridement within 48h of treatment initiation Rigorous nutritional assessment
Joseph et al. (113)	RCT	WM—closed system including Bioclusive Transparent Dressing (Johnson and Johnson)	3x/day plus saline applied 3x/day		3 and 6 weeks or until wound closure
Lavery et al. (341)	Non-RCT	V.A.C.® NR	Every 48 hrs	NR	12 and 20 weeks	Successful treatment endpoint if closure through secondary endpoint or through a surgical intervention (i.e., flaps, grafts and primary closure) or if adequate granulation for closure by these methods was documented.	NR	Surgical debridement
Lavery et al. (341)	Non-RCT	Wet-to-moist	Well-monitored care—patients from 5 RCTs			Successful treatment endpoint when either the wound was completely healed, i.e., wound closure (no drainage) or full epithelialization with no drainage.		Surgical debridement
Schwien et al. (126)	Non-RCT	V.A.C.® NR	NR	NR	Tracked while NPWT was applied plus 7 days following removal	NR	NR	NR
Schwien et al. (126)	Non-RCT	Control NR	NR		Tracked start of care through end of care	NR	NR	NR
McCallon et al. (120)	Non-RCT	V.A.C.® Continuous at 125 mmHg for first 48 hours/ Intermittent suction (125 mmHg) applied thereafter Foam dressing as provided by the manufacturer	Every 48 hours	Wound border traced with fine-tipped marker onto a piece of clear acetate film. Progress assessed by photography.	Every 48 hours at each dressing change	Until satisfactory healing occurred and defined as: Delayed primary intention. Split thickness skin graft, myocutaneous flap, or suture closure Secondary intention. Granulation tissue formation and epithelialization.	NR	Surgical debridement Strict non-weight bearing or bedrest
McCallon et al. (120)	Non-RCT	Saline-moistened gauze (wounds not allowed to desiccate)	Twice a day		3x/week		NR	Surgical debridement Strict non-weight bearing or bedrest

NR = Not reported
RCT = Randomized controlled trial

^* All studies reported using V.A.C.® (KCI, USA Inc.)

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Table 26. Results for Outcome Measures Reported in Comparison Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure Ulcers

Reference	Study Type	Treatments	N	Wounds Healed	Mean (SD) Change in Wound Area (cm²) or Volume (cm³)	Satisfactory Healing	Other Important Outcomes	Adverse Events Resulting in Discontinuation of Treatment
Blume et al. (108)	RCT	V.A.C.®	169	73 (43.2%)	Reported for day 28 -4.32 (significant difference; P = 0.021)	63.6 ±36.57 days (mean ±SD)	NR	22
Blume et al. (108)	RCT	Advanced Moist Wound Therapy (AMWT)	166	48 (28.9%)	Reported for day 28 -2.53	78.1 ±39.29 days (mean ±SD)		18
Armstrong et al. (109)	RCT	V.A.C.®	63 acute (51.6%) 14 chronic (35%)	34 acute (54%) 9 chronic (64.3%)	NR	Log-rank test comparing the time-to-event profiles was significant in favor of NPWT group over SWT for acute wounds (P = 0.030)	NR	NR
Armstrong et al. (109)	RCT	Standard Wound Therapy (SWT)	59 acute (48.4%) 26 chronic (65%)	22 acute (37.3%) 11 chronic (42.3%)
Wanner et al. (118)	RCT	V.A.C.®	11	11	Decrease over time similar in both groups. Increase in volume was often measured 7d after first measurements in both groups.	27 (10) d mean (SD)	NR	NR
Wanner et al. (118)	RCT	Gauze soaked with Ringer's solution	11	11		28 (7) d mean (SD)
Ford et al. (110)	RCT	V.A.C.®	20	2 (10%)	51.8% - mean % reduction in volume Mean reduction in length, width, and depth respectively were 36.9 cm, 40.0 cm, and 33.6 cm	NR	NR	Coronary artery disease—1 Respiratory arrest secondary to Guillain-Barre—1 Treatment group not reported
Ford et al. (110)	RCT	Healthpoint System (HP)	15	2 (13%)	42.1% - mean % reduction in volume Mean reduction in length, width and depth respectively were 18.7 cm, 19.0 cm, and 31.0 cm (p = 0.10, p = 0.11, p = 0.90 respectively)
Joseph et al. (113)	RCT	V.A.C.®	NR	NR	Percent change in wound volume over time: 78% (p = 0.038) Change in depth: 66% (p <0.00001) Change in width over time: p = 0.02 No significant difference in change in length between groups (p = 0.38)	NR	Granulation tissue formation in 13 (64% of wounds)	NR
Joseph et al. (113)	RCT	Moist wound therapy			Percent change in wound volume over time: 30% Change in depth: 20%		An adequate (100%) granulating bed rarely seen	NR
Lavery et al. (341)	Non-RCT	V.A.C.®	1135	39.5% (12 wk) 46.3% (20 wk)	NR	` NR	NR	NR
Lavery et al. (341)	Non-RCT	Wet-to-moist	586	23.9% (12 wk) 32.8% (20 wk)	NR	` NR	NR	NR
Schwien et al. (126)	Non-RCT	V.A.C.®	NR		NR	NR	Instances of hospitalization for wound problem (n, %) Stage III—1 (3%) Stage IV—2 (7%) Total—3 (5%) Instances of emergent care for wound problem (n,%) Stage III—0 Stage IV—0 Total—0	NR
Schwien et al. (126)	Non-RCT	Control	NR		NR	NR	Instances of hospitalization for wound problem (n, %) Stage III—194 (11%) Stage IV—116 (20%) Total—310 (14%) Instances of emergent care for wound problem (n,%) Stage III—126 (7%) Stage IV—63 (11%) Total—189 (8%)	NR
McCallon et al. (120)	Non-RCT	V.A.C.®	5	# of wounds decreased in size = 4 (healed by delayed primary intention) # of wounds increased in size = 1 (healed by secondary intention)	28.4% (±24.3) average decrease	Average: 22.8 (±17.4) days	NR	NR
McCallon et al. (120)	Non-RCT	Saline-moistened gauze	5	# of wounds decreased in size = 2 (healed by delayed primary intention) # of wounds increased in size = 3 (healed by secondary intention)	9.5% (±16.9) average increase	Average: 42.8 (±32.5) days	NR	NR

NR = Not reported
RCT = Randomized controlled trial
*All studies reported using V.A.C.® (KCI, USA Inc.)

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Skin Graft

Table 27. Key Study Design Characteristics of Comparison Studies of NPWT Devices* Used to Secure Skin Graft

Reference	Study Type	Wound Type	Number of Patients Enrolled	Comparison Treatment	Inclusion Criteria	Exclusion Criteria	Length of Study	Attrition
Vuerstaek et al. 2006 (115)	RCT	Chronic leg	60	Conventional (hydrocolloids, alginates)	All patients hospitalized with chronic, venous, combined venous and arterial, or microangiopathic (arteriolosclerotic) leg ulcers of >6 month's duration; after surgical treatment options had been exhausted and extensive ambulatory treatment (>6 months) in an outpatient clinic according to the Scottish Intercollegiate Guideline Network (SIGN) had failed	Ulcer chronicity <6 months duration, age >85 years old, the use of immune suppression, allergy to wound products, malignant or vasculitis origin, or ABI <0.60	12 months	11
Moisidis et al. 2004 (112)	RCT	Split-thickness skin graft (STSG)	22 (patients used as own controls)	Bolster dressing	Adults admitted to Liverpool Hospital from July 2001 to July 2002 with wounds 25 cm² or larger and clinically ready for skin grafting	NR	2 weeks	2
Korber et al. 2008 (340)	Non-RCT	Chronic leg ulcer	54	SOC	Mesh grafts transplanted in the Department of Dermatology, Essen, Germany from April 2003 to April 2005	NR	NR	NR
Vidrine et al. 2005 (342)	Non-RCT	STSG	44	Bolster dressing plus splint	Consecutive skin-grafted radial forearm donor sites treated between October 2003 and November 2004	NR	4 weeks	NR
Stone et al. 2004 (133)	Non-RCT	STSG	40	Cotton bolster dressing	Trauma patients admitted between January 2001 and January 2003 to Charleston Area Medical Center, WV who received STSG	2 burn patients with heavily contaminated and extremely large wounds	Grafts considered completely successful or total failures
Scherer et al. 2002 (132)	Non-RCT	STSG	61	Cotton bolster dressing	Identified all patients on the trauma surgery service who required STSG during an 18-month period	NR	NR	NR
Genecov et al. 1998 (131)	Non-RCT	STSG	10 (patients used as own controls)	OpSite	Patients requiring coverage of denuded surfaces	NR	7 days	NR

NR = Not reported
RCT = Randomized controlled trial
* All studies reported using V.A.C.® (KCI, USA Inc.)

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Table 28. Patient Characteristics in Comparison Studies of NPWT Devices* Used to Secure Skin Graft

Reference	Study Type	Number of Patients	Mean (SD) Age (years)	Sex	Comorbidities	Number of Wounds	Mean (SD) Baseline Wound Area (cm²) or Volume (cm³)	Severity of Wounds	Mean (SD) Duration of Wound
Vuerstaek et al. (115)	RCT	V.A.C.®: 30	Median: 74 Range: 53-81	M7 F23	Smoking: 6 (21%) Diabetes mellitus type II: 5 (17%) Immobility: 12 (41%) Hypertension: 13 (45%) Infection signs: 8 (28%)	NR	Median: 33 Range: 2-150	Ulcer type Venous origin: 13 Combined venous/arterial origin: 4 Arteriolosclerotic origin: 13	8 Median (Range: 6-24)
Vuerstaek et al. (115)	RCT	Control: 30	Median: 72 Range: 45-83	M7 F23	Smoking: 9 (30%) Diabetes mellitus type II: 5 (17%) Immobility: 13 (43%) Hypertension: 12 (40%) Infection signs: 6 (20%)		Median: 43 Range: 3-250	Venous origin: 13 Combined venous/arterial origin: 4 Arteriolosclerotic origin: 13	7 Median (Range: 6-12)
Moisidis et al. (112)	RCT	20	Median: 64 Range: 27-88	M12 F8	NR	20	128 cm² Range: 35 to 450 cm²	Acute: 10 Subacute or chronic (>5d): 10	18d (Range: 0 to 90d)
Korber et al. (340)	Non-RCT	Total: 54 V.A.C.®: NR	66.1	M23 F31	Diabetes: 15	28	Comparable	NR	NR
Korber et al. (340)	Non-RCT	Control: NR	69.8	M23 F31	Diabetes: 15	46	Comparable	NR	NR
Vidrine et al. (342)	Non-RCT	V.A.C.®: NR	62	M16 to F19 ratio	NR	20	59 (21)	NR	NR
Vidrine et al. (342)	Non-RCT	Control: NR	60	M18 to F25 ratio		25	56 (27)		NR
Stone et al. (133)	Non-RCT	V.A.C.®: 17	35.4 ±14	NR	NR	21	105.6 (88)	Wound Site: Face:1 Torso: 3 Extremity: 17	NR
Stone et al. (133)	Non-RCT	Control: 23	39.0 ±16.7			25	150.2 (78)		NR
Scherer et al. (132)	Non-RCT	V.A.C.®: 34	33 ±23	NR	NR	NR	Graft size, cm² 387 ±573	NR	NR
Scherer et al. (132)	Non-RCT	Control: 27	41 ±20				984 ±996		NR
Genecov et al. (131)	Non-RCT	10	Range: 39 to 81	M4 F6	Paraplegia: 2 Diabetes mellitus: 4 Systemic infections: 2 Hemodialysis dependence: 3 Traumatic wounds: 3	10	32-380 cm²	NR	NR

NR = Not Reported
RCT = Randomized controlled trial
* All studies reported using V.A.C.® (KCI, USA Inc.)

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Table 29. Treatment-Related Characteristics in Comparison Studies of NPWT Devices* Used to Secure Skin Graft

Reference	Study Type	Treatments	Treatment Change	Wound Assessment	Frequency of Measurements	Treatment Duration	Prior Treatments	Concurrent Treatments
Vuerstaek et al. (115)	RCT	V.A.C.® Continuous Negative Pressure (CNP): -125 mmHg Foam dressing	Day 4	NR	Twice a week until wound closure	Wound healing 1)= Wound bed preparation defined as the time between debridement and application of the punch skin grafts 2)= Time to complete healing (primary end point) defined as the period between debridement and 100% epithelialization (wound closure).	Ambulatory conservative local treatment (6 months)	Debridement Post-graft all patients received treatment with a non-adhesive dressing and compression bandage
Vuerstaek et al. (115)	RCT	Control SOC according to SIGN guideline and compression therapy	Day 4		Twice a week until wound closure		Ambulatory conservative local treatment (6 months)
Moisidis et al. (112)	RCT	V.A.C.® CNP: -100 mmHg Foam sponge	Left intact for 5d Patients used as own controls NPWT used on superior half in 10 patients and inferior half in remaining 10	At 2 weeks	NR	Graft take was recorded both quantitatively (expressed as a percentage of epithelialization (recorded by gross inspection) and qualitatively (rated as poor, satisfactory, good or excellent)	3 patients experienced prior graft failure	If grafts were placed on lower limbs, patients were immobilized with leg elevation and deep venous thrombosis prophylaxis Once dressing was removed, the entire graft was treated with daily petroleum gauze, saline-soaked gauze and crepe.
Moisidis et al. (112)	RCT	Control Mepitel, Acriflavice wool and foam sponge		At 2 weeks	NR		3 patients experienced prior graft failure
Korber et al. (340)	Non-RCT	V.A.C.® Black sponge -125 mmHg	1^st between postoperative day 5 or 7	NR	Between day 10 and 14	Mesh graft take	NR	Postoperative compression therapy for patients with venous leg ulcer or a mixed ulcer
Korber et al. (340)	Non-RCT	Control	1^st between postoperative day 5 or 7
Vidrine et al. (342)	Non-RCT	V.A.C.®/Control	Removed between day 4 and 6	Senior author	Day 7 (1 week) and week 4	4 weeks	NR	NR
Stone et al. (133)	Non-RCT	V.A.C.®/control	NR	NR	NR	Completely successful graft take	NR
Scherer et al. (132)	Non-RCT	V.A.C.® CNP: -125 mmHg	4^th postoperative day unless signs suggested infection	NR	NR	Successful graft take	NR	Bed rest, a sling, or a splint
Scherer et al. (132)	Non-RCT	Control	4^th postoperative day unless signs suggested infection	NR	NR	Successful graft take	NR	Bed rest, a sling, or a splint
Genecov et al. (131)	Non-RCT	V.A.C.®	Days 4 and 7	Blinded assessor analyzed biopsies		Degree of re-epithelialization	NR	NR
Genecov et al. (131)	Non-RCT	Control	Days 4 and 7	Blinded assessor analyzed biopsies		Degree of re-epithelialization	NR	3.33

CNP = Continuous negative pressure
NR = Not reported
RCT = Randomized controlled trial
SOC = Standard of care
* All studies reported using V.A.C.® (KCI, USA Inc.)

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Table 30. Results for Outcome Measures Reported in Comparison Studies of NPWT Devices* Used to Secure Skin Graft

Reference	Study Type	Treatments	N	Wounds Healed	Mean (SD) Change in Wound Area (cm²) or Volume (cm³)	Satisfactory Healing	Other Important Outcomes	Adverse Events Resulting in Discontinuation of Treatment
Vuerstaek et al. (115)	RCT	V.A.C.®	30	29	NR	Primary endpoint Time to complete healing: 29d(95% CI: 25.5 to 32.5) Secondary endpoint Median percentage skin graft survival: 83%	Ulcer relapse at 1 year follow-up: 52% QOL measured by EQ 5D 77 Pain measured by SF MPQ: 1	NR
Vuerstaek et al. (115)	RCT	Control	30	29		Time to complete healing: 45d (95% CI: 36.2 to 53.8) Median percentage skin graft survival: 70%	Ulcer relapse at 1 year follow-up: 42% QOL measured by EQ 5D: 76 Pain measured by SF MPQ: 1	NR
Moisidis et al. (112)	RCT	V.A.C.®	20 patients used as own controls	20	NR	Quantitative (degree of epithelization): not significant Greater degree: 6 (30%) Same degree: 9 (45%) Less: 5 (25%) Qualitative Graft take: Subjectively determined to be significantly better: Better: 10 (50%) Equivalent: 7 (35%) Worse: 3 (15%)	NR	NR
Korber et al. (340)	Non-RCT	V.A.C.®	NR (28 wounds)	26	NR	Mesh graft take rate: 92.9%	NR	NR
Korber et al. (340)	Non-RCT	Control	NR (46 wounds)	31		67.4%		NR
Vidrine et al. (342)	Non-RCT	V.A.C.®	NR (20 wounds)	20	Average graft take at 1 wk: 99% Average graft take at 4 wk: 92%	Overall complete STSG take rate: 60%	NR	NR
Vidrine et al. (342)	Non-RCT	Control	NR (25 wounds)	25	Average graft take at 1 wk: 97% Average graft take at 4 wk: 81	Overall complete STSG take rate: 52%		NR
Stone et al. (133)	Non-RCT	V.A.C.®	17 (21 grafts)	Graft take: 100%	n/a	Duration of dressing: 4.8 ±0.8	Mean hospital stay: 20.9 ±10	NR
Stone et al. (133)	Non-RCT	Control	23 (25 grafts)	1 graft failure		5.2 ±2.4	15.3 ±7.5	NR
Scherer et al. (132)	Non-RCT	V.A.C.®	34	NR	NR	Graft take, % 96 ±6	Repeat STSG to same site 1 (3%) Total LOS, d 27 ±16	NR
Scherer et al. (132)	Non-RCT	Control	27			89 ±20	Repeat STSG to same site 5 (19%) Total LOS, d 32 ±25	NR
Genecov et al. (131)	Non-RCT	V.A.C.®/ Control	10 (used as own controls)	10	NR	V.A.C.® re-epithelialize faster than control: 7 No difference in rate of re-epithelialization: 2 More rapid re-epithelialization with OpSite: 1	NR	NR

EQ-5D = EuroQol group quality-of-life instrument
NR = Not reported
RCT = Randomized controlled trial
SF-MPQ = Short Form-McGill Pain Questionnaire

* All studies reported using V.A.C.® (KCI, USA Inc.)

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Acute Wounds

Table 31. Key Study Design Characteristics of Comparison Studies of NPWT Devices^* Used to Treat Acute Wounds

Reference	Study Type	Wound Type	Number of Patients Enrolled	Comparison Treatment	Inclusion Criteria	Exclusion Criteria	Length of Study	Attrition
Stannard et al. 2006 (125)	RCT	Postoperative wounds	Study 1: 44 Study 2: 44	Study 1: pressure dressing Study 2: post operative dressing	Hematoma study: Age >18 years; involvement in traumatic injury with subsequent surgical incision which drained a minimum of 5d after surgery; and willingness to comply with the protocol. Fracture study: Patients with one of three high-risk fractures after high-energy trauma-calcaneus, pilon, and tibial plateau (Schatzker IV through VI); age >18 yrs; and willingness to comply with the study protocol.	Hematoma study: Surgical incisions that did not have at least moderate drainage for 5d after surgery; infection of the wound; neoplasm involving the wound; pregnancy; or the presence of a fistula. Fracture study: Low-energy fracture pattern tibial plateau fractures' nonoperative, percutaneous treatment, or external fixation as the primary form of stabilization; open fractures that require repeat debridement; skin or soft tissue neoplasm involving the incision site; and pregnancy.	NR	NR
Timmers et al. (106)	Non-RCT	Post-traumatic osteomyelitis	124	SOC	Consecutive patients with osteomyelitis with one recurrence who presented at the Leiden University Medical Center between March 1999 and February 2003.	NR	Until either two consecutive culture swabs taken within a few days had become sterile or when enough new granulation tissue had formed to permit surgical wound closure.	NR
Simek et al. 2008 (123)	Non-RCT	Deep sternal	62	Conventional (debridement, chest rewiring, closed irrigation)	Patients undergoing treatment for deep sternal wound infection from March 2002 to December 2007	NR	1 year follow up	NR
Yang et al. (72)	Non-RCT	Fasciotomy	68	Saline-soaked wet-to-dry dressings	Patients who underwent two-incision fasciotomies for documented, traumatic compartment syndrome of the leg with the release of all four compartments	NR	Time to definitive closure by either delayed primary closure with sutures or split-thickness skin graft coverage	NR
Fuchs et al. 2005 (23)	Non-RCT	Deep sternal	68	Conventional	Incidence of deep sternal wound infections from bypass or heart valve replacements from 1998 to 2000 treated with conventional treatment and from 2000 to 2003 treated with V.A.C.®; sternal infections met the criteria of the Centers for Disease Control and Prevention	NR	Follow up at least until the sternum was rewired (primary wound healing), until wound healing was achieved without rewiring (secondary wound healing), or until the patient died with an open sternum	NR
Immer et al. 2005 (130)	Non-RCT	Deep sternal wound infection (DSWI)	55	Sternal excision and musculocutaneous flap	Patients with DSWI (El Oakley class 2B) from sternotomies performed between January 1998 and December 2003; diagnosis based on sternal dehiscence and positive bacteriologic culture of the sternum or the anterior mediastinum.	NR	NR	NR
Segers et al. 2005 (122)	Non-RCT	Post sternotomy mediastinitis (PM)	63	Closed drainage technique (CDT)	All patients treated from PM after cardiac surgery at the Academic Medical Center between 1/1/92 and 12/31/03	NR	NR	29% (18 deaths; 9 NPWT, 9 control)
Sjogren et al. 2005 (139)	Non-RCT	PM	101	Conventional (open dressings, closed irrigation, pectoral muscle flaps or omentum flaps)	At least one of the following CDC criteria for PM: An organism isolated from culture of mediastinal tissue or fluid Evidence of mediastinitis was seen during operation; One of the following conditions, chest pain, sterna instability, or fever (>38° C) was present and there was either purulent discharge from the mediastinum or an organism isolated from blood culture or culture of drainage of the mediastinal area	Patients presenting signs of infection but with negative substernal tissue cultures; patients with sterile dehiscences or superficial sternal wound infections	NR	NR
Domkowski et al. 2003 (129)	Non-RCT	PM	102	Standard of Care (SOC)	Between 1997 and 2002, patients from Duke University Hospital, The Durham VA Hospital	Patients with superficial wound infections or fat necrosis	NR	NR
Song et al. 2003 (124)	Non-RCT	Sternal	35	SOC	35 consecutive patients who suffered complications of their cardiac procedure resulting in a sternal wound from March 1999 to March 2001; all patients had a median sternotomy and all sternal wounds involved the tissues superficial and deep to the sternum	NR	NR	NR
Doss et al. 2002 (128)	Non-RCT	Post-sternotomy Osteomyelitis	42	SOC	Patients treated for post-sternotomy Osteomyelitis (SOM) between 1998 and 2000	NR	NR	NR
Catarino et al. 2000 (137)	Non-RCT	Post-sternotomy mediastinitis (PM)	17	Closed drainage and irrigation (CDI)	Patients with post-sternotomy mediastinitis (PM) occurring from September 1998 to August 1999 (group A) and from September 1997 to August 1998 (group B). All patients had sternal dehiscence and an infected mediastinum.	Superficial sternal wound infections, suture and wire abscesses, chronic sternal osteomyelitis, and sterile sternal dehiscences	Until wound closure	NR
Shilt et al. 2004 (138)	Non-RCT	Traumatic Wounds	31	Standard of care (SOC)	Medical records of patients <18 years admitted to Wake Forest University School of Medicine, Winston Salem, NC between 1992 and 2001 for treatment of lower extremity lawnmower injuries	Largest diameter of the wounds was <2 cm or if wound care consisted of primary closure	Upon wound healing or further reoperation	1 control lost to f/u
Kamolz et al. 2003 (343)	Non-RCT	Burn	7	Silver sulphadiazine crème	All patients of the last 5 months with bilateral partial thickness hand burns	Patients not admitted within the time interval of 6h after trauma; children <20 years of age, pregnant, and patients with a history of allergic reactions	Upon further reoperation or wound heal	NR
Gabriel et al. 2008 (339)	Non-RCT	Infected	30	SOC	Trunk and extremity wounds with documented qualitative cultures with >105 organisms, age >40 yrs, and documented necrotic tissue. V.A.C.®: patients with a diagnosis of complex, open, infected wounds treated with NPWT instillation between January 2005 and April 2006 Control: treated between January 2004 and December 2005	NR	Until wound closure	NR
Ozturk et al. 2008 (117)	Non-RCT	Fournier's gangrene	10	SOC	Between January 2006 and August 2007 patients with Fournier's gangrene and treated at the Dept of General Surgery, Uludag University School of Medicine, Bursa, Turkey	NR	Time to wound closure	NR
Rinker et al. 2008 (121)	Non-RCT	Open Tibia Fracture	105 (55 subacute analyzed)	SOC	Hospital and clinic records of 105 consecutive patients who underwent a free muscle flap for treatment of a Gustilo grade IIIB or IIIC tibia fracture between 1991 and 2005.	NR	NR	NR
Huang et al. 2006 (127)	Non-RCT	Limb	24	SOC (gauze soaked with saline)	A diagnosis of acute necrotizing fasciitis	NR	NR	NR
Labler et al. 2004 (71)	Non-RCT	Soft-tissue	23	Epigard® dressing	Patients with severe open fractures of the lower extremity classified as type IIIA or IIIB (Gustilo) and admitted as an emergency; all fractures result of a high-energy trauma	All type IIIC fractures due to associated valcular injuries	12 months after definitive soft-tissue coverage

NR = Not reported
RCT = Randomized controlled trial

* All studies reported using V.A.C.® (KCI, USA Inc.)

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Table 32. Patient Characteristics in Comparison Studies of NPWT Devices* Used to Treat Acute Wounds

Reference	Study Type	Number of Patients	Mean (SD) Age (years)	Sex	Comorbidities	Number of Wounds	Mean (SD) Baseline Wound Area (cm²) or Volume (cm³)	Severity of Wounds	Mean (SD) Duration of Wound
Stannard et al. (125)	RCT	Hematoma study: 44 V.A.C.®: 13	48 yrs (21-96)	M 36 F 8	NR	44	NR	Injury Severity Scores (ISS) 14.1	<5d
	RCT	Control: 31	48 yrs (21-96)	M 36 F 8	NR	44	NR	13.9	<5d
	RCT	Fracture study: V.A.C.®: 20	41 yrs (19-78)	M 32 F 12	NR	20	NR	ISS 11.1	NR
	RCT	Control: 24	41 yrs (19-78)	M 32 F 12	NR	24	NR	10.1	NR
Timmers et al. (106)	Non-RCT	V.A.C.®: 30	52 (26-81)	M14 F16	18 (60%) diabetes mellitus, smoker, cardiovascular disease, pulmonary disease	30	NR	NR	NR
Timmers et al. (106)	Non-RCT	Control: 94	47 (9-85)	M58 F36	54 (57.4%) diabetes mellitus, smoker, cardiovascular disease, pulmonary disease	94	NR	NR	NR
Simek et al. (123)	Non-RCT	V.A.C.®: 34	66.4 ±9.8	M 52% F 48%	Diabetes mellitus: 52.9% COPD: 32.4% Immunosuppressive therapy: 14.7% Renal impairment: 23.5%	34	NR	NR	NR
Simek et al. (123)	Non-RCT	Control: 28	71.2 ±7.9	M 68% F 32%	Diabetes mellitus 60.7% COPD: 25% Immunosuppressive therapy: 10.7% Renal impairment: 35.7%	28	NR	NR	NR
Yang et al. (72)	Non-RCT	V.A.C.®: 34	NR	NR	NR	68	NR	NR	NR
Yang et al. (72)	Non-RCT	Control: 34	NR	NR	NR	70	NR	NR	NR
Fuchs et al. (23)	Non-RCT	V.A.C.®: 35	68.5 (63.9-74.5)	M 76%	Diabetes—55% Coronary heart disease—97%	35	NR	Type I: 0 Type II: 9 Type IIIa: 12 Type IIIb: 10 Type V: 4	NR
Fuchs et al. (23)	Non-RCT	Control: 33	68.5 (64.4-74.9)	M 85%	Diabetes—59% Coronary heart disease—97%	33	NR	Type I: 4 Type II: 1 Type IIIa: 17 Type IIIb: 4 Type V: 7	NR
Immer et al. (130)	Non-RCT	V.A.C.® only: 19	60.1 ±11.8	M 13 F 6	COPD: 1 (5.3%) Diabetes: 7 (36.8) Immunosuppression: 2 (10.5%) Arterial hypertension: 13 (68.4%)	19	NR	NR	Diagnosis DSWI (days) 17.5 ±5.1
	Non-RCT	V.A.C.® plus Excision and flap: 19	66.6 ±7.2	M 14 F 5	COPD: 3 (15.8%) Diabetes 10 (52.6%) Immunosuppression: 1 (5.3%) Arterial hypertension: 14 (73.7%)	19	NR	NR	71.7 ±213.7
	Non-RCT	Excision plus flap: 17	69.5 ±8.1	M 10 F 7	COPD: 6 (35.3%) Diabetes: 7 (41.2%) Immunosuppression: 0 Arterial hypertension: 17 (100%)	17	NR	NR	36.7 ±46.5
Segers et al. (122)	Non-RCT	V.A.C.®: 29	65.9 (38-81)	M 17 F 12	Diabetes: 11 (37.9%) COPD: 10 (34.5%)	29	NR	Type I: 4 (13.8%) Type II: 2 (6.9%) Type IIIa: 3 (10.3%) Type IIIb: 9 (31%) Type IVa: 9 (31%) Type V: 2 (6.9%)	Presenting within 6 weeks after operation
Segers et al. (122)	Non-RCT	Control: 34	66.7 (20-81)	M 30 F 4	Diabetes: 8 (23.5%) COPD: 6 (17.6%)	34	NR	Type I: 7 (20.6%) Type II: 2 (5.9%) Type III: 8 (23.9%) Type IVa: 6 (17.6%) Type V: 1 (2.9%)	NR
Sjogren et al. (139)	Non-RCT	V.A.C.®: 61	67.3 (10.1)	M 44 F 17	Diabetes: 26 (43%) Obesity: 23 (38%) LVEF <0.30: 14 (23%) COPD: 12 (20%)	61	NR	Type I: 12 (20%) Type II: 7 (11%) Type IIIa: 13 (21%) Type IIIB: 26 (43%) Type IVa: 1 (2%) Type V: 2 (3%)	NR
Sjogren et al. (139)	Non-RCT	Control: 40	68.9 (7.8)	M 38 F 2	Diabetes: 12 (30%) Obesity: 12 (30%) LVEF <0.30: 4 (10%) COPD: 4 (10%)	40		Type I: 10 (25%) Type II: 3 (8%) Type IIIa: 7(18%) Type IIIb: 7 (18%) Type IVa: 9 (23%) Type IVb: 2 (5%) Type V: 2 (5%)
Domkowski et al. (129))	Non-RCT	Data only reported for total study population		NR	NR	NR	NR	NR	NR
Song et al. (124)	Non-RCT	V.A.C.®: 17	63 (31-88)	M 10 F 7	CABG: 14 Valve: 1 Aortic dissection: 3 Mediastinitis: 15 Chronic infection: 2 Sterile wound:1	17	NR	NR	Up to 6 weeks
Song et al. (124)	Non-RCT	Control: 18	63 (23-77)	M 14 F 4	CABG: 13 Valve: 2 Heart transplant: 1 Pericardiectomy: 1 Mediastinitis: 13 Chronic infection: 3 Sterile wound:1	18	NR		Up to 6 weeks
Doss et al. (128)	Non-RCT	V.A.C.®: 20	Median: 66 (45-82)	M 9 F 11	Bilateral internal mammary artery: 5 Diabetes: 9 COPD: 4 Overweight: 7	20	NR	NR	Postoperative presentation: day 7 to 21
Doss et al. (128)	Non-RCT	Control: 22	66 (50-83)	M 19 F 3	Bilateral internal mammary artery: 9 Diabetes: 9 COPD: 6 Overweight: 8	22			day 5 to 31
Catarino et al. (137)	Non-RCT	V.A.C.®: 7	68 (64-74)	M 5 F 2	Coronary heart disease; diabetes; and high BMI	7	NR	NR	NR
Catarino et al. (137)	Non-RCT	Control: 10	66 (46-75)	M 7 F 3	Coronary heart disease; diabetes; and high BMI	10	NR
Shilt et al. (138)	Non-RCT	V.A.C.®: 16	3.9 (1-8)	M 10 F 6	NR	16	NR	With fractures—12	NR
Shilt et al. (138)	Non-RCT	Standard of Care (SOC): 15	8.5 (2-18)	M 8 F 7	NR	15	NR	With fractures—8	NR
Kamolz et al. (343)	Non-RCT	V.A.C.®: 7 Patients used as their own controls	44.2 (22.4)	NR	NR	14	NR	Partial thickness	<6h
Kamolz et al. (343)	Non-RCT	Silver sulphadiazine crème (SSD): 7	44.2 (22.4)	NR	NR	14	NR	Partial thickness	<6h
Gabriel et al. (339)	Non-RCT	V.A.C.®: 15	57.13 ±11.64	NR	Necrotizing fasciitis—3 Pressure ulcer—2 Open joint—5 Surgical wound—1 Lower extremity wound—1 Soft tissue loss of lower extremity—2 Abdominal surgical wound dehiscence -1	15	127.33 ±137.87	NR	NR
Gabriel et al. (339)	Non-RCT	Standard of Care (SOC): 15	59.40 ±10.29		Necrotizing fasciitis—4 Pressure ulcer—5 Open joint—6	15	173.00 ±123.73
Ozturk et al. (117)	Non-RCT	V.A.C.®: 5	56 (33-77)	M 4 F 1	NR	5	NR	3 local 2 disseminated	NR
Ozturk et al. (117)	Non-RCT	V.A.C.®: 5	56 (31-64)	M 3 F 3		5		3 local 2 disseminated
Rinker et al. (121)	Non-RCT	V.A.C.®: 17	Median: 40 (Range: 11-64)		NR	60 flaps	NR	NR	Subacute wounds had flap performed on post-injury days 8 to 42
Rinker et al. (121)	Non-RCT	Control: 38	Median: 40 (Range: 11-64)		NR	60 flaps	NR	NR
Huang et al. (127)	Non-RCT	V.A.C.®: 12	57.75	M 7 F 5	Diabetes—6 Fever—6 Leukocytosis—7 Shock—3 Trauma—3 Infection- 9	12	Wounds varied between 30 and 15 cm in length and 13 and 3 cm in width	NR	NR
Huang et al. (127)	Non-RCT	SOC: 12	62.58	M 9 F 3	Diabetes—9 Fever—9 Leukocytosis –6 Shock—2 Trauma—4 Spontaneous infection—8	12	Wounds varied between 32 and 12 cm in length and 12 and 4 cm in width
Labler et al. (71)	Non-RCT	V.A.C.®: 12	Range: 18-68	M 8 F 4	NR	14	NR	Mangled Extremity Severity Score: 2 (n = 1); 3 (2); 4 (3); 5 (4); 6 (2); 7 (2)
	Non-RCT	Control: 11	Range: 20-89	M 8 F 3	NR	12	NR	Mangled Extremity Severity Score: 2 (1); 3 (3); 4 (3); 5 (3); 6 (1); 9 (1)

COPD = Chronic obstructive pulmonary disease
LVEF = Left ventricular ejection fraction
NR = Not reported
NS = Not significant
RCT = Randomized controlled trial

* All studies reported using V.A.C.® (KCI, USA Inc.)

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Table 33. Treatment-Related Characteristics in Comparison Studies of NPWT Devices* Used to Treat Acute Wounds

Reference	Study Type	Treatments	Treatment Change	Wound Assessment	Frequency of Measurements	Treatment Duration	Prior Treatments	Concurrent Treatments
Stannard et al. (125)	RCT	Hematoma study: V.A.C.®	At least every other day	NR	NR	Until cessation of drainage of hematoma	NR	If drainage continued at day 10, patients returned to the OR for an evacuation of the hematoma with irrigation and debridement
	RCT	Dressing	Daily			Until cessation of drainage of hematoma	NR
	RCT	Fracture study: V.A.C.®	NR	NR	NR	Wound drainage had dropped to grade 3 or below	NR	NR
	RCT	Control				Wound drainage had dropped to grade 3 or below	NR	NR
Timmers et al. (106)	Non-RCT	V.A.C.® Polyvinyl alcohol (PVA) foam (instilled 2-3x/day) and pressures ranging from -300 mmHg to -600 mmHg	First day after debridement and subsequently every 3-4 days	Wound cultures	Each dressing change	Until two consecutive swabs taken a few days apart were either sterile or showed skin bacteria only, or when enough granulation tissue had grown into the wound to permit surgical wound closure. Alternatively, if spontaneous wound closure occurred during therapy, NPIT was ended.	NR	Debridement Antibiotic therapy for a minimum of six weeks
Timmers et al. (106)	Non-RCT	Control	NR	NR
Simek et al. (123)	Non-RCT	V.A.C.®	NR	NR	NR	Wound bed was free of infection, covered by well-vascularized granulation tissue and the C-reactive protein level dropped to 50 mg/l, the chest was reclosed	NR	NR
Simek et al. (123)	Non-RCT	Control	NR	NR	NR		NR	NR
Yang et al. (72)	Non-RCT	V.A.C.®: CNP: -125 mmHg	Every 48 hours	NR	NR	Until wound closure by delayed primary fashion or covered with STSG	NR	Irrigation and debridement	NR
Yang et al. (72)	Non-RCT	Control	NR	NR	NR		NR	Irrigation and debridement	NR
Fuchs et al. (23)	Non-RCT	V.A.C.® CNP: -125 to -150 mmHg With severe pain, -75 mmHg 3 polyurethane foam sponges	3-7d	NR	NR	Freedom of the sternal wound from microbiological cultures	NR	Wound incision and removal of sternal wires Aggressive debridement
Fuchs et al. (23)	Non-RCT	Control	NR	NR	NR	Freedom of the sternal wound from microbiological cultures		Wound incision and removal of sternal wires Aggressive debridement Irrigation Wound drainage Packing/delayed closure
Immer et al. (130)	Non-RCT	V.A.C.® Pressure between -75 mm and -125 mm	48-72 hrs	Bacteriologic cultures	NR	NR	NR	Intravenous antibiotics Debridement every 48-72 hours
	Non-RCT	V.A.C.® plus secondary sternal excision and musculocutaneous flap
	Non-RCT	Sternal excision + flap
Segers et al. (122)	Non-RCT	V.A.C.® Continuous Negative Pressure (CNP): -125 mmHg Foam dressing	Initially after 48h; thereafter every 4-5d	NR	NR	A well-vascularized wound completely covered by granulation tissue, C reactive protein levels were <50 mg/l and cultures did not show pathogenic bacteria, sternal closure was performed	NR	Aggressive debridement
Segers et al. (122)	Non-RCT	Control	NR	NR	NR		NR	Aggressive debridement
Sjogren et al. (139)	Non-RCT	V.A.C.®		NR	NR	Wound considered clean including a bed of fresh granulation tissue, the sternum was rewired or, when necessary, additional wound-healing measures, i.e., omentoplasty and pectoralis flap	NR	Surgical debridement
Sjogren et al. (139)	Non-RCT	Control	Several times daily	NR	NR		NR	Surgical debridement
Domkowski et al. (129)	Non-RCT	V.A.C.®	NR	NR	NR	NR	NR	Debridement
Domkowski et al. (129)	Non-RCT	SOC	NR	NR	NR	NR	NR	Debridement
Song et al. (124)	Non-RCT	V.A.C.® CNP: -75 to -125 mmHg Foam dressing	Every other day	Plastic surgery and physical therapy staff	NR	Definitive closure determined by the gross appearance of the wound and hemodynamic stability of the patient	NR	Surgical debridement Antimicrobial layer of Acticoat^* (Smith & Nephew)
Song et al. (124)	Non-RCT	Control	Twice a day	Plastic surgery and physical therapy staff	NR		NR	Surgical debridement Topical antimicrobial agent
Doss et al. (128)	Non-RCT	V.A.C.® -125 mmHg Foam dressing	Every 2-3d	NR	NR	Primary closure after granulation tissue filled the defect and all microbiological cultures were negative	NR	Debridement
Doss et al. (128)	Non-RCT	Control	NR	NR	NR		NR	Debridement
Catarino et al. (137)	Non-RCT	V.A.C.® CNP 125 mmHg Foam dressing	48-72 hrs	NR	NR	Until wound closure; evident granulation tissue and negative microbiological cultures	NR	Debridement Broad-spectrum antibiotics
Catarino et al. (137)	Non-RCT	Control		NR	NR		NR	Debridement Broad-spectrum antibiotics
Shilt et al. (138)	Non-RCT	V.A.C.®	Every 72 hours	NR	NR	16.7d	Amputation 11	Oral antibiotics (9) Intravenous antibiotic (15)
Shilt et al. (138)	Non-RCT	Control		NR	NR		14
Kamolz et al. (343)	Non-RCT	V.A.C.® Open-cell polyurethane foam	Controlled daily	Use of Indocyanine Green (ICG) video angiographies	Daily	NR	NR	Intravenous injections of 0.2 mg/kg ICG
Kamolz et al. (343)	Non-RCT	Control	Controlled daily	Use of Indocyanine Green (ICG) video angiographies	Daily	NR	NR	Intravenous injections of 0.2 mg/kg ICG
Gabriel et al. (339)	Non-RCT	V.A.C.® Continuous Negative Pressure (CNP): -125 mmHg Foam dressing IV bag containing normal saline, sterile water or silver nitrate solution for instillation	NR	NR	Weekly	Until wound closure	NR	Repeatedly sharply debrided
Gabriel et al. (339)	Non-RCT	Control	NR	NR	NR	Until wound closure	NR	Repeatedly sharply debrided
Ozturk et al. (117)	Non-RCT	V.A.C.® CNP 125 mmHg GranuFoam® large dressing	Every 72 hrs in the OR	NR	NR	After wounds were clinically healed or wound cultures were negative, tertiary wound closure or split thickness grafting was performed	NR	Surgical debridement
Ozturk et al. (117)	Non-RCT	Control	Daily or more if needed	NR	NR		NR	Surgical debridement Taken into OR every 48 hours for dressing changes and jet lavage
Rinker et al. (121)	Non-RCT	V.A.C.® Intermittent: -125 mmHg; Petrolatum-impregnated gauze was placed between any exposed bone and the foam dressing	Every 48 hours	NR	NR	NR	NR	NR
Rinker et al. (121)	Non-RCT	Control (wet-to-dry gauze or a moist occlusive dressing)	NR
Huang et al. (127)	Non-RCT	V.A.C.® Intermittent: -125 mmHg	48-72 hrs	NR	NR	Healed completely or when a minor procedure for closure was required, i.e., simple wound stitching or skin grafting		Mean debridement per patient: 4.41
Huang et al. (127)	Non-RCT	Control	3-6x/d	NR	NR			3.33
Labler et al. (71)	Non-RCT	V.A.C.® Foam CNP - 125 mmHG	Every 48 hours depending on wounds and patient's condition	Bacterial cultures	Every 48 hours	Until primary or secondary closure	NR	3 debridements and primary immobilization of the fracture “Second-look” operations carried out every 48 hours which included subsequent thorough debridements, fracture, redislocation and repeated irrigation with normal saline. 3rd generation cephalosporin
	Non-RCT	Control	Every 48 hours depending on wounds and patient's condition	Bacterial cultures	Every 48 hours	Until primary or secondary closure	NR

CNP = Continuous negative pressure
NPIT = Negative pressure instillation therapy
NR = Not reported
RCT = Randomized controlled trial
STSG = Split-thickness skin graft

^* All studies reported using V.A.C.® (KCI, USA Inc.)

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Table 34. Results for Outcome Measures Reported in Comparison Studies of NPWT Devices* Used to Treat Acute Wounds

Reference	Study Type	Treatments	N	Wounds Healed	Mean (SD) Change in Wound Area (cm²) or Volume (cm³)	Satisfactory Healing	Other Important Outcomes	Adverse Events Resulting in Discontinuation of Treatment
Stannard et al. (125)	RCT	Hematoma study: V.A.C.®	13	13	NR	Drainage (Mean) 1.6 (Range: 0-5)	Need for surgical evacuation: 1 (8%)	NR
	RCT	Control:	31	31	NR	3.1 (Range: 0-11)	5 (16%)	NR
	RCT	Fracture study: V.A.C.®	20	20	NR	Drainage (Mean): 1.8 (0-6)	No significant difference in rates of infection or wound dehiscence	NR
	RCT	Control	24	24		4.8 (0-24)		NR
Timmers et al. (106)	Non-RCT	V.A.C.®	30	30	NR	7 (11.9%) of wounds failed to become sterile however due to the amount of new granulation tissue, surgical closure of the wound was undertaken.	Median duration of hospital stay (days)(Range) 36 (15-75) Recurrence of osteomyelitis: 3 (10%) Median duration of total hospital stay per patient (days)(Range) 36 (15-75)	NR
Timmers et al. (106)	Non-RCT	Control	94		NR	NR	Median duration of hospital stay (days)(Range) 27.3 (3 -196) (p = 0.624) Recurrence of osteomyelitis: 55 (58.5%) (p < 0.0001) Median duration of total hospital stay per patient (days)(Range) 73 (6-419) (p < 0.0001)	NR
Simek et al. (123)	Non-RCT	V.A.C.®	34	NR	NR	5.8% failure rate	Overall length of therapy:14.9 ±7.9d In-hospital mortality 5.8% 1-year mortality: 14.7%	NR
Simek et al. (123)	Non-RCT	Control	28			39.2% failure rate	Overall length of therapy:14.3 ±11.9d In-hospital mortality 21.4 1-year mortality: 39.2%
Yang et al. (72)	V.A.C.®	34	Wounds healed (68 (100%)) Ratio of wound closure to skin-grafted wounds: 49:19	NR		Overall time to definitive wound closure by either delayed primary closure with sutures or STSG: 6.7 days (V.A.C.®) and 16.1 days (non-V.A.C.®) (p = 0.0001)	NR	NR
Yang et al. (72)	Control	34	Wounds healed (70 (100%)) Ratio of wound closure to skin-grafted wounds: 45:25				NR	NR
Fuchs et al. (23)	Non-RCT	V.A.C.®	35	34	NR	Primary or secondary wound healing achieved: 21d (IQR:15 to 26d)	Time from diagnosis of sternal infection until freedom from infection: Significantly shorter: 16d (IQR: 10 to 26d) 1-year mortality rate: 2.9%	Death due to vacuum-related perforation: 1
Fuchs et al. (23)	Non-RCT	Control	33	29		28d (IQR: 18 to 54d)	Time from diagnosis of sternal infection until freedom from infection: 26d (IQR: 19 to 51d) 1-year mortality rate: 25.3%	Deaths: 4 2 due to bleeding 2 due to septic shock
Immer et al. (130)	Non-RCT	V.A.C.®	19	NR	NR	NR	Survival: significantly better in Group 1 (V.A.C.® only) than Group 2 or Group 3 SF-36: Patients from groups 2 and 3 scored significantly lower in the aspects of physical function, general health and vitality than Group 1.	NR
	Non-RCT	V.A.C.® plus excision plus flap	19
	Non-RCT	Excision plus flap	17
Segers et al. (122)	Non-RCT	V.A.C.®	29	21 (73%)	NR	Therapy duration (d): 22.8 (4-68)	Hospital stay SSI (mean): 46.1 (Range: 10-74)	Mortality caused by SSI: 4 (13.8%)
Segers et al. (122)	Non-RCT	Control	34	14 (41%)		Therapy duration(d): 16.5 (2-38)	35.7 (Range: 10-165)	7 (20.6%)
Sjogren et al. (139)	Non-RCT	V.A.C.®	61	61	NR	Treatment duration: 12 ±9d (Range: 2-66) Total length of stay (LOS): 25 ±17d (Range: 7-103)	90-day mortality (significantly lower) 0 (p <0.01) Overall survival (significantly better) 97% at 6 mos. 93% at 1 year 83% at 5 years	NR
Sjogren et al. (139)	Non-RCT	Control	40	40		Treatment duration: 10 ±14d (Range: 1-53) Total LOS: 25 ±20 (Range: 1-87)	90-day mortality: 6 (15%) Overall survival: 84% at 6 mos. 82% at 1 year 59% at 5 years
Domkowski et al.(129)	Non-RCT	V.A.C.®	96	NR	NR	Omental transposition: 33 Pectoralis flap: 10 Secondary closure: 53	NR	Multisystem organ failure: 2 Overwhelming Sepsis: 2
Domkowski et al.(129)	Non-RCT	Control	6
Song et al.(124)	Non-RCT	V.A.C.®	17	15 (14 by definitive closure; 1 by secondary intention (V.A.C.®))	NR	Average days between initial debridement and definitive closure of the sternal wound (not significant) 6 ±1.3d	NR	Mortality: 3 (2 from aspiration pneumonia and 1 from multisystem organ failure)
Song et al.(124)	Non-RCT	Control	18	17		8 ±2.9d		Mortality: 1 patient died due to aspiration pneumonia
Doss et al. (128)	Non-RCT	V.A.C.®	20	NR	Reduction in wound size: 4.63 cm²/day (Range: 2.9-6.5)	NR	Duration of treatment: Mean: 17.2 ±5.8 Total hospital stay: Mean: 27.2 ±6.5d	Hospital mortality: 1 (5%)
Doss et al. (128)	Non-RCT	Control	22		3.2 cm²/day (Range: 2.7-3.6)		Duration of treatment: Mean: 22.9 ±10.8 Total hospital stay: Mean: 33.0 ±11.0d	Hospital mortality: 1 (4.5%)
Catarino et al.(137)	Non-RCT	V.A.C.®	7	7	NR	11d median (6-26d)	LOS: 27d median (22-49) Treatment failure: none (significantly greater for Control)	NR
Catarino et al.(137)	Non-RCT	Control	10			13d median (8-20)	LOS: 50d median (27-98) Treatment failure: 5
Shilt et al.(138)	Non-RCT	V.A.C.®	16	16	NR	Free flap: 3 Split thickness: 8 Cross-foot flaps: 3 Full-thickness: 1 1 lost to f/u	LOS —16.8 (5-47) Modified Loder grade Excellent:10; Good: 1; Fair: 1; Poor: 4 Outcomes Loder Satisfactory: 11; Unsatisfactory: 5 Vosburgh (a functional outcome questionnaire): 23.0 (19-24) # of procedures: 4.6 (2-10)	None
Shilt et al.(138)	Non-RCT	Standard of Care (SOC)	15	15	NR	Free flap: 8 Split thickness: 5 Cross-foot flaps: 1 Full-thickness: 1	LOS —10.2 (3-24) Modified Loder (a functional outcome classification) grade Excellent: 6; Good: 1; Fair: 0; Poor: 7 Outcomes Loder Satisfactory: 7; Unsatisfactory: 7 Vosburgh: 22.6 (21-24) # of procedures: 3.4 (1-7)	None
Kamolz et al.(343)	Non-RCT	V.A.C.®	7 patients used as own controls	14	NR	Skin grafts —2; No operation —3; Keratinocytes—2	A massive reduction of edema formation (up to 50 ml) within the burn wound	NR
Kamolz et al.(343)	Non-RCT	Silver sulphadiazine crème				Skin grafts—4; No operation —3
Gabriel et al.(339)	Non-RCT	V.A.C.®	15	100%	NR	Days to wound closure: 13.20 ±6.75	Days to patient discharge: 14.67 ±9.18	NR
Gabriel et al.(339)	Non-RCT	Control	15	66.7%		29.60 ±6.54	39.20 ±12.07
Ozturk et al.(117)	Non-RCT	V.A.C.®	5	5	NR	9d (Range: 7-15)	VAS 2.4 LOS: 14d; Range: 11-19	NR
Ozturk et al.(117)	Non-RCT	Control	5	5		10d (8-16)	VAS 6.8 LOS: 13d;10-18
Rinker et al.(121)	Non-RCT	V.A.C.®	17 (17 flaps)	17 (100%)	NR	Time to bony union (Significantly less) 4.9 months	LOS, days 20.8 ±10.5	NR
Rinker et al.(121)	Non-RCT	Control	38 (43 flaps)	36 (84%)		7.2 months	20.2 ±8.5	NR
Huang et al.(127)	Non-RCT	V.A.C.®	12	NR	Reduction: 47% in dimension and 49% in volume	NR	Hospital stay: 32.1d (mean)	Deaths: 1 (8%) Amputation: 2
Huang et al.(127)	Non-RCT	Control	12		Reduction: 41% in dimension and 39% in volume		34.3d (mean)	Deaths: 1 (8%) Amputation: 2
Labler et al. (71)	Non-RCT	V.A.C.®	12	11	NR	11 of 13 healed uneventfully	Rate of infection: 2 of 13	Early amputation; 1
	Non-RCT	Control	11	5	NR	5 of 10 healed uneventfully	Rate of infection: 6 of 11	Early amputation: 1

LOS = Length of hospital stay
NR = Not reported
RCT = Randomized controlled trial
SSI = Surgical site infection
* All studies reported using V.A.C.® (KCI, USA Inc.)

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Key Question 3

Table 35. Characteristics of Patients with Acute Wounds

Reference	Patient Population (n)	Age (yrs)	Sex	Comorbidities	Wound Type	Number of Wounds	Wound Area (cm²) or Volume (cm³)	Severity of Wounds
Bannasch et al. 2008 (344)	5	Mean 37.8, Range: 8-58	4 M 1 F	1: DM	Pretibial bone exposure, exposure of calcaneus and Achilles tendon, exposure of all extensor tendons of the foot, exposed tibias and hardware (secondary to plate osteosynthesis), posterior aspect of lower leg	5	NR	NR
Bendewald et al. 2007 (82)	5	Median: 21 Range: 16-63	3 M 2 F	NR	Complex pilonnidal disease underwent wide excision	5	Mean: 205 cm³ Range: 90 cm³-410 cm³	NR
Bendo et al. 2007 (76)	13	Mean: 58 Range: 34-83	5 M 8 F	6: diabetes 1: atrial fibrillation 1: HIV	Posterior lumbar wound drainage management of the spine prior to debridement	13	NR	NR
Brandi et al. 2008 (345)	18	Avg: 56, Range: 45-78	NR	12: Peripheral vascular disease (PVD) and 4 of these with type 2 DM	Traumatic loss of tissue in the lower limbs involving exposure of bone and tendon structures	18	NR	NR
Dhir et al. 2008 (346)	19	Mean: 63.2, Range: 48-75	17 M 2 F	16: hypertension 4: IDDM 9: malnutrition 7: CAD 7: PVD 4: NIDDM	Complex head and neck wounds	33	Larger cutaneous defects >10 cm²	Neck and facial abscesses
Rhode et al. 2008 (347)	5	Mean: 41.2, Range: 33-59	5 F	BMI Range: 24.4 -36.1 2: smokers	Patients had radical excisional therapy for stage III vulvar hidradenitis suppurativa	5	NR	NR
Rozen et al. 2008 (348)	9	Mean: 69, Range: 32-99	9 F	5: hypertension 1: asthma 5: smoking history 1: ESRF on dialysis 1: type II DM 2: COPD 2: AS 1: AF 3: stroke 2: IHD 3: hypercholesterolaemia 1: hyperparathyroidism 1: CCF 1: granulomatous hepatitis 1: anemia	Lower limb split skin grafts	9	NR	NR
Steiert et al. 2008 (349)	42	Mean: 46, Range: 15-84	29 M 13 F	NR	Open extremity fractures	33 lower extremity 10 upper extremity	NR	Severe extremity trauma
Svensson et al. 2008 (149)	28	Median: 75, Range: 48-88	Of the 33 wounds, 21 M 12 F	10: ≥80 yrs 12: women 14: DM 23: lower limb ischemia	Perivascular surgical site infections in groin	33	NR	Infected groins
Bhattacharyya et al. 2007 (350)	38	Infected Mean: 39 ±8.8 Non-infected Mean: 39 ±10.5	32 M 6 F	7: smokers 1: DM	Gustilo grade III B open fractures	38	10 cm or larger	11 wounds infected; 27 non-infected
Bollero et al. 2007 (141)	35	Avg: 40, Range: 14-72	29 M 6 F	NR	Acute complex traumas of lower limbs	13 foot 5 ankle 15 leg 1 knee 3 thigh	NR	NR
Dedmond et al. 2007 (27)	49	Avg: 36.8, Range: 18-70	40 M 10 F	NR	Grade/type III open tibial shaft fractures	24 IIIA 24 IIIB 2 IIIC	NR	NR
Helgeson et al. 2007 (351)	NR	NR	NR	NR	Exposed tendon and/or bone Combat-related wounds	16 wounds treated 18 times: 6 leg 1 shoulder 6 foot 2 forearm 2 thigh 1 hip	Avg: 87 cm² Range: 15-275 cm² Median: 47 cm²	NR
Labler and Trentz 2007(352)	13	Range: 13-71	10 M 3 F	NR	Severe soft tissue injuries as a result of high energy pelvic trauma	13	NR	NR
Machen 2007 (74)	Over 50 patients	NR	NR	NR	Traumatic war wounds	Over 50 wounds	NR	NR
Peck et al. 2007 (353)	192	Range: 4-68	NR	NR	Major vascular injuries	134 extremity 33 neck and vessel 25 torso	NR	NR
Rao et al. 2007 (163)	29	Median: 60, Range: 31-80	14 M 15 F	NR	Open abdominal wounds	29	NR	NR
Segers et al. 2007 (354)	5	NR	NR	NR	Open window thoracostomy	5	NR	NR
Senchenkov et al. 2007 (355)	17	Mean: 65, Range: 42-82	9 M 8 F	17: soft tissue sarcoma 2: DM 1: smoker	Irradiated extremity wounds reconstructed w/split thickness skin grafts	17	Skin graft size: Mean: 118 cm² Range: 23-240 cm²	NR
Andrews et al. 2006 (88)	12	Average: 61.8 Range: 34-86	8 M 4 F	66.6%: Cardiac disease 66.6%: Cancer 58.3%: Pulmonary disease 58.3%: Hypertension 16.6%: Diabetes 8.3%: Liver and kidney disease	Complicated head and neck wounds	13	All in cm: 8x6 10x5 7x6 9x6 5x4 9x6 16x8 8x9 21x14 14x8 10x9 10x7	9: Bone exposure
Cothren et al. 2006 (356)	14	Men: Mean: 41 ±5.7	79% M, 21% F	NR	Open abdomen	14	NR	NR
DeFranzo et al. 2006 (156)	100	Range: infancy to 78	48 M 52 F	NR	Partial thickness and complete full-thickness abdominal wounds	63 partial thickness 37 complete full-thickness	Avg: 200 cm² Range: 30 cm² - 700 cm²	45 of partial: contaminated/ infected 19 of full: contaminated/ infected
Heller et al. 2006 (87)	21	Mean: 48 Range: 5-75	11 M 10 F	10: Morbid obesity 11: Diabetes 4: Steroid use 6: Smoking 8: Hypertension 4: Preoperative chemotherapy	Abdominal wound dehiscence	21	NR	NR
Leininger et al. 2006 (111)	77	NR	NR	NR	High-energy soft tissue wounds (trauma, deployed wartime environment)	39 lower extremity 12 back 7 chest 20 upper extremity 6 abdomen 4 buttock/ perineum	Only reported size of 33 wounds: Mean: 45.3 cm² SD: 30.6 cm² Median: 32 cm² Range: 12-160 cm²	NR
Labler et al. 2005 (357)	18	Range: 13-69	16 M 2 F	NR	Open abdomen after laparotomy	18	NR	NR
Rosenthal et al. 2005 (89)	23	Average: 59	17 M 6 F	4: Diabetes requiring insulin therapy during wound management	Head and neck reconstruction	23	NR	NR
Stoeckel et al. 2005 (358)	18	Mean: 52	18 F	2: smokers 4: previous radiation therapy to affected breast	Complex breast wounds	15	NR	NR
Savolainen et al. 2004 (359)	36	Median: 72, Range: 46-98	21 M 15 F	NR	Inguinal wound in vascular surgery	36	NR	13 frank infection 11 non-infected 12 clinically contaminated
Stone et al. 2004 (90)	48	NR	NR	NR	Abdominal trauma	48	NR	NR
Herscovici et al. 2003 (360)	21	Avg: 45.9, Range: 16-83	12 M 9 F	NR	High energy soft tissue injuries	6 tibial 10 ankle 1 forearm 1 elbow 1 femur 1 pelvis 1 below knee stump	Tibial: 73 cm², Range: 5-261 ankle & foot: 38 cm², Range: 8-52 forearm: 65 cm² elbow: 60 cm² femur: 156 cm² pelvis: 264 cm² below knee stump: 400 cm²	NR
Stonerock et al. 2003 (77)	15	NR	12 M 3 F	NR	Abdominal wounds	15	NR	Abdominal compartment syndrome, inability for abdominal closure at initial operation, or inability to close the abdomen upon re-exploration
Suliburk et al. 2003 (166)	29	Men: Mean: 38 ±3	20 M 9 F	NR	Open abdomen after severe trauma	29	NR	NR
Garner et al. 2001 (86)	14	Mean: 40.1 + 4.7	4 M 10 F	NR	Open abdomens	14	NR	NR
DeFranzo et al. 2000 (157)	75	NR	NR	NR	Lower extremity wounds w/ exposed bone	29 motor vehicle accidents 9 gunshot 11 other assorted trauma 13 dehisced or infected orthopedic surgical wounds 3 pressure sores 5 failed flaps 5 miscellaneous	NR	NR
Avery et al. 2000 (92)	15	NR	NR	NR	Radial forearm donor site with split skin graft	15	Mean: 36 cm²	NR

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Table 35a. Characteristics of Patients with Chronic Wounds (continued)

Reference	Patient Population (n)	Age (yrs)	Sex	Comorbidities	Wound Type	Number of Wounds	Wound Area (cm²) or Volume (cm³)	Severity of Wounds
Bapat et al. 2008 (153)	Group A: 23 superficial sternal infection received V.A.C.® as definitive treatment	Group A: 69 ±13	Group A: 20 M, 3 F	Group A: BMI 30.9 ±3.7 9 DM	Superficial sternal infections and deep sternal infections	28 superficial 21 deep	NR	NR
	Group B: 5 superficial sternal infection received V.A.C.® followed by surgical closure	Group B: 69 ±12.1	Group B: 4 M, 1 F	Group B: BMI 30.3 ±2.9 1 DM
	Group C: 12 deep sternal infection received V.A.C.® as definitive treatment	Group C: 69 ±11.4	Group C: 11 M, 1 F	Group C: BMI 31.8 ±4.6 3 DM
	Group D: 9 deep sternal infection received V.A.C.® and surgery	Group D: 67 ±12	Group D: 8 M, 1 F	Group D: BMI: 30.7 ±5.1 4 DM
Baharestani et al. 2008 (93)	11	Avg: 54 Median: 57 Range: 18-82	7 M, 4 F	7 DM 1 Malnourished 3 peripheral vascular disease 2 Obesity	Necrotizing Fascitis	16	NR	NR
Chen et al. 2008 (160)	26	Mean: 69, Range: 49-82	21 M 5 F		Deep sternal wound infections	26	NR	NR
Ennker et al. 2008 (361)	45	Avg: 68	29 M 16 F	16: IDDM 35: hyperlipidemia 40: hypertension 19: COPD 7: Peripheral arterial disease 9: Carotid artery stenosis	Deep sternal wound infections	45	2 cm x 2 cm to 2 cm x 18 cm	NR
Fleck et al. 2008 (362)	22	Mean: 61.5 ±15, Range: 8-79	15 M 7 F	NR	Open chest	22	NR	NR
Gdalevitch et al. 2008 (154)	36	Median: 67.1, Range: 49-88	22 M 14 F	66.7% hyperlipidemia 64% smoking 58.3% DM 55.6% hypoalbuminemia 38.9% positive blood culture 25% CLD 22% high degree bony exposure and sternal instability 11.1% CKD 8.3% PVD 5.6% immunocompromised	Superficial and deep sternal wounds	36	Depth: 19.4% ≥4 cm 80.6% ≤4 cm	NR
Ha et al. 2008 (140)	74	Median: 65.5, Range: 19-95	40 M 34 F	60.8% DM 86.7% of DM had PVD, Stroke, retinopathy, dialysis	Surgical wounds	25 foot 13 toe 13 groin 9 leg 9 thigh 7 trunk 1 neck	Median: 18.7 cm² Range: Length 0.5-20 cm, Width 0.5-15 cm	29 surgical incision breakdown 42 infected secondary to causes other than surgery 6 infected that dehisced after initial closure
Hamed et al. 2008 (363)	10	Mean: 65 ±16	5 M 5 F	6: DM 7: hypertension	Lymphatic fistulas (LFs) and lymphoceles: 9 patients groin lymphatic complications 1 patient neck lymphatic complication	10	NR	NR
Horch et al. 2008 (155)	21	Mean: 69.8, Range: 46-80	12 M 9 F	17: PAOD with or without concomitant renal insufficiency 2: autoimmune disease with immuno suppressive medication 10: diabetes 2: acute pancreatitis	Severe lower limb soft tissue loss and infection with exposed bone, infected ulcers of lower leg with exposed bones and joints	21	NR	All patients presented with necrotic tendons and or affected and exposed tibia or fistula bones
Labanaris et al. 2008 (364)	80	Men: Mean: 63, Range: 53-84 Women: Mean: 66, Range: 50-82	64 M 16 F	NR	Chronic wounds	26 pressure ulcers 17 wound trauma 24 diabetic ulcer 13 venous stasis ulcer	NR	NR
Lopez et al. 2008 (365)	8 with 10 V.A.C.® applications	Age at V.A.C.® application: 84.5 ±51 days	6 M 2 F	NR	Complex abdominal wounds	8	Mean: 13.6 ±6 cm² Range: 8.5-25 cm²	Wound infection and dehiscence
Mokhtari et al. 2008 (366)	38	Mean: 69 ±SD 10.6	29 M 9 F	15: DM 10: BMI >30 9: COPD 16: recent MI 3: Renal Failure	Deep sternal wound infection	38	NR	NR
Ploumis et al. 2008 (80)	73	Average: 58.4 Range: 21-82	34 M 39 F	Chronic leukocytic leukemia, lupus anticoagulant, chronic renal failure, alcohol abuse, metastatic colon cancer, obesity, malnutrition, diabetes, splenectomy, hodgkin disease, radiation exposure, rheumatoid arthritis, and smoking	Spinal wound infections	79	NR	NR
Wondberg et al. 2008 (161)	30	Avg: 63, Range: 27-86	21 M	NR	Open abdomen caused by abdominal sepsis; origin of sepsis: 21 colon 3 stomach 5 stomach or bowel 1 unclear	30	NR	NR
Horn et al. 2007 (78)	11	Range: 7-19	6 M 5 F	2: Myelomeningocele 2: Cerebral Palsy 1: Scoliosis after paraplegia from chemotherapy for acute myelogenous leukemia 1: Fusion for kyphotic deformity secondary to collapse of vertebral bodies from an aneurysmal bone cyst 4: Moderate to severe developmental delay	Infected spinal wounds	11	NR	Range of time of onset of infection: 2 weeks-5 years
Jones et al. 2007 (150)	13	Mean: 50.2, Range: 14 -76	NS	Malignant disease, anemia	Deep infections of the spine	13	NR	6 Staph 1 complicated Candida 4 mixed bacterial infections 2 Pseudomonas aeruginosa infections 1 Serratia marcescens infection
Kotsis and Lioupis 2007 (73)	8	Range: 24-74	NR	4: Hypertension 4: Morbid obesity 3: Diabetes mellitus II 2: Renal failure 1: Hepatitis C 1: Malignancy 1: Pulmonary insufficiency	Vascular graft infection confined to the groin	8	NR	NR
McCord et al. 2007 (142)	68	Mean: 8.5 yrs Range: 7 days-18 yrs	36 M 32 F	NR	Pressure ulcers, extremity wounds, dehisced surgical wounds, open sternal wounds, wounds w/fistulas, complex abdominal wall defects	13 pressure ulcers 18 extremity wounds 19 dehisced surgical wounds 10 open sternal wounds 3 wounds w/fistulas 6 complex abdominal wall defects	NR	NR
Perez et al. 2007 (95)	37	Avg: 58 Range: 34-86	18 M 19 F	1: Gallbladder cancer 2: Pancreatic cancer 5: Stomach cancer 2: Colon Cancer 10: Diverticulitis 10: Bowel obstruction 3: Pancreatitis 2: Ulcer	21: Severe abdominal sepsis 16: Abdominal compartment syndrome	37	NR	NR
Shrestha et al. 2007 (367)	9	Range: 30-67	5 M 4 F	NR	Deep wound infection after renal transplantation	9	NR	Dehiscence, associated with copious discharge
Strecker et al. 2007 (318)	63 patients, 34 treated with V.A.C.®	63 patients: Avg: 68.5, Range: 29-83	63: 61.9% M, 38.1% F	63: 49.2% DM 90.5% arterial hypertension 19% COPD 27% smokers 23.8% Renal Failure	Deep sternal wound infections	34	NR	NR
Van Rhee et al. 2007 (368)	6	Avg: 12.6	3 M 3 F	NR	Deep wound infection after instrumented spinal fusion in pediatric neuromuscular scoliosis	6	NR	Wound dehiscence
Gorlitzer et al. 2006 (369)	5	Avg: 69, Range: 24-72	3 M 2 F	1: DM 1: colon cancer, CRF, COPD, heart failure	Descending necrotizing mediastinitis	5	NR	NR
Labler et al. 2006 (370)	15	Mean: 48, Range: 18-75	4 M 11 F	2: Nicotine 3: alcohol 2: tumor 2: radiation before surgery 2: arterial hypertension 3: DM 3: CRF 2: Chronic Heart Disease (CHD) 1: COPD BMI's (kg/m²) 36, 39, 28, 34, 32, 59	Deep subfascial infection after dorsal spinal surgery	15	NR	NR
Morgan et al. 2006 (164)	9	Range: 56-85	7 M 2 F	7: DM 3: hypertension 2: MI 2: Renal disease 1: smoker 1: kidney transplant 3: Coronary artery disease (CAD) 2: Congestive heart failure (CHD) 1: CRF 1: Peripheral arterial disease (PAD)	Chronic lower extremity wounds	12	All cm: 3x3 3x4 3x3 3x4 3x3 3x3 3x3 3x3 3x5	Non-healing ulcerations
Pelham et al. 2006 (371)	10	Mean: 52, Range: 13-76	4 M 6 F	DM, obesity, hypertension and a history of smoking (number of patients not specified)	Chronic infected wounds with exposed orthopedic implants: 6 chronic wounds (present for more than 6 weeks) 4 subacute wounds (present for 1-4 weeks) All wounds classified as complex, defined as having exposed bone, exposed tendon, or exposed orthopedic implants and/or open joint space with stripped bone	10	8 patients had a wound exceeding 20 cm²	Skin breakdown distal tibia; large anterior skin slough with exposed hardware; long-standing draining sinus with partially exposed lateral plate; long-standing exposed total knee arthroplasty hardware with large anterior skin and soft-tissue slough; long-standing exposed hardware; Infected total knee arthroplasty with skin breakdown; infected open reduction internal fixation; open wound exposed hardware, infected open reduction internal fixation, infected open reduction internal fixation
Sartipy et al. 2006 (151)	5	Range: 58-79	2 M 3 F	1: DM 2: COPD, obesity	Deep sternal wound infection	5	NR	NR
Agarwal et al. 2005 (372)	103	Avg: 52, Range: 3-91	67 M 36 F	Pulmonary: 2 congenital 16 COPD Cardiovascular: 17 congenital 6 endocarditis/pericarditis 5 myopathy 65 CAD 14 CHF Renal: 6 insufficiency/failure 11 End-stage renal disease (ESRD) Autoimmune: 11 transplant 5 connective tissue 42 hypertension 37 DM	Sternal wounds	103	NR	16 superficial infections 21 sterile 66 mediastinitis
Cowan et al. 2005 (373)	22	Mean: 67.9 ±10.9	68.2% M	BMI 30.9 ±7.8 40.9% smokers 54.6% DM 36.4% RF 31.8% CHF 58.1% hypertension 18.2% COPD	Deep sternal wounds with or without bony involvement	22	NR	82% dehiscence 59% sternal instability 73% fluid collection by computed tomography 41% osteomyelitis 50% staphylococcus aureus
Lee et al. 2005 (374)	9	Range: 47-73	NR	NR	Refractory sternal infection: 2 patients type IVA mediastinitis after one failed therapeutic trial 7 patients type IVB mediastinitis after more than one failed therapeutic trial	9	NR	NR
Mendonca et al. 2005 (375)	15	Avg: 49.3, 22-80	9 M 6 F	10: DM 2: chronic osteomyelitis 2: Peripheral vascular disease (PVD) 1: spina bifida 11: peripheral neuropathy, RF, and wound dehiscence	Chronic, non-healing wounds on foot and ankle	18	Avg: 7.41 cm², Range: 2-10 cm²	11 clinical evidence of active infection 5 stage II wounds 10 stage III wounds (stages are based on Wagner-Meggitt classification)
Sjogren et al. 2005 (179)	46	Mean: 68.5 ±SD 10.3	32 M 14 F	11: DM 22: BMI >30 2: preoperative dialysis 23: recent MI 8: COPD 14: HF 6: RF	Post sternotomy mediastinitis	46	NR	NR
Mehbod et al. 2004 (376)	20	Avg: 55, Range: 31-81	12 M 8 F	3: DM 3: previous splenectomy 10: smokers 1: lupus 1: Hodgkin lymphoma 1: HIV	Deep spine infections w/ exposed instrumentation	20	NR	16 draining wound 4 presented back pain & temperature
O'Conner et al. 2004 (377)	17	Avg: 43.5, Range: 24-76	11 M 6 F	Group I: 1 DM and ESRD and steroids 1 chronic lymphocytic leukemia and prostate cancer 2 HIV positive	Chest wounds	Group I: 7 primary chest wall process	Avg 16x7 cm, Range: 7x3 cm to 21x11 cm	Group I: 4 necrotizing soft-tissue infections 3 penetrating trauma resulting in large contaminated wounds w/ significant loss of chest wall integrity
O'Conner et al. 2004 (377)				Group II: 1 multiple sclerosis and PVD and steroids 1 closed head injury 1 DM and morbid obesity 1 cerebral abscess 1 DM and COPD and CAD 1 cerebral vascular accident 1 cardiomyopathy	Chest wounds	Group II: 10 with empyema with extension to chest wall	Avg 16x7 cm, Range: 7x3 cm to 21x11 cm	Group II: 2 with empyema necessitates 6 with postpneumonic empyema 4 with postoperative empyema
Routledge et al. 2004 (378)	6	Range: 22-65	3 M 3 F	NR	Deep wound infections after heart and lung transplantation	6	NR	NR
Scholl et al. 2004 (81)	13	Mean: 61 Range: 43-73	11 M 2 F	4: History of diabetes mellitus 5: History of CABG	Postoperative deep sternal wounds	13	NR	7: Acute purulent sternal infections 6: chronic sternal osteomyelitis
Demaria et al. 2003 (145)	7	Mean: 74, 71-80	6 M 1 F	4: DM All: cardiopulmonary bypass	Non-healing infected sternal surgical wound	7	NR	Wound dehiscence w/local inflammation followed by cloudy discharge some had low grade fever
Gustafsson et al. 2003 (146)	40	Median: 68, Range: 49-87	26 M 14 F	NR	Deep sternal wound infections	40	NR	NR
Isago et al. 2003 (91)	10	Mean: 61.2 + 4.5 Range: 43-88	7 M 3 F	All paralyzed or bedridden	Pressure ulcers	10	Mean area: 62.6 cm² Mean depth: 1.9 cm	Stage IV - penetration into the deep fascia with involvement of muscle and bone
Wongworawat et al. 2003 (75)	14	Average: 48 Range: 21-66	NR	NR	Orthopedic infections	14	Average: 70 cm² Range: 22.5-288 cm²	NR
Armstrong et al. 2002 (85)	31	Mean: 56.1 ± 11.7	24 M 7 F	Diabetes	Diabetic foot ulcers	31	Surface area: 27.9 + 19.5 cm²	3.2%: Grade 1 lesions 45.2%: Grade 2 lesions 51.6%: Grade 3 lesions (Grades based on University of Texas' diabetic foot classification system)
Clare et al. 2002 (379)	17	Avg: 64.4	8 M 9 F	13: DM 9: IDDM 10: peripheral neuropathy 8: severe PVD	Non-healing wounds of lower extremity	5 midfoot/ forefoot 6 ankle/ hindfoot 6 lower limb	NR	6 postoperative dehiscence of surgical incision
Fleck et al. 2002 (380)	11	Median: 64.4, Range: 50-78	5 M, 6 F	NR	Sternal wound infection	11	NR	NR
Gustafsson et al. 2001 (381)	16	Male: Median: 68, Range: 49-82 Female: Median: 67, Range: 63-73	13 M, 3 F	NR	Deep sternal wound infections	16	NR	NR
Hersh et al. 2001 (94)	16	Range: 45-79	6 M 10 F	NR	Deep sterna wounds	16	NR	NR
De Lange et al. 2000 (167)	Group 1: 23	Group 1: Mean: 46, Range 17-77	NR	NR	Group 1: stage IV pressure sores	Group 1: 26	NR	NR
	Group 2: 42	Group 2: Mean: 62, Range: 20-89	NR	NR	Group 2: major postoperative wound infection in abdomen, groin, knee, ankle	Group 2: 42	NR	NR
	Group 3: 19	Group 3: Mean 67, Range: 46-85	NR	NR	Group 3: chest wall dehiscence after cardiac surgery complicated by mediastinitis	Group 3: 19	NR	NR
	Group 4: 13	Group 4: Mean: 44, Range: 21-80	NR	NR	Group 4: subacute wounds	Group 4: 13	NR	NR
	Group 5: 3	Group 5: Mean: 67, Range: 59-73	NR	NR	Group 5: soft tissue defect after radiation therapy, soft tissue defect after subcutaneous leakage chemo, diabetes ulcer on ankle	Group 5: 3	NR	NR
Deva et al. 2000 (382)	30	Mean: 50.7, Range: 15.4-88.3	20 M 10 F	NR	Wounds unsuitable for surgical closure (pressure sores)	8 sacral 7 ischial 8 trochanter/hip 7 lower limb	Mean width: 5.7 cm, Range: 1.7-22 cm Mean length: 9.9 cm, Range: 1.9-27 cm Mean depth: 3 cm, Range: 0.5-9 cm Mean volume: 171 cm³, Range: 16.1-2,228 cm³	Grade III pressure sores (full thickness ulceration down to but not through deep fascia) Mean pretreatment duration: 418 days, Range: 8-1,650 days
Lang et al. 1999 (159)	82	NR	68 M 14 F	NR	Soft tissue lesions of the ankle and foot	82	NR	NR

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Table 35b. Characteristics of Patients with Mixed Wound Types (continued)

Reference	Patient Population (n)	Age (yrs)	Sex	Comorbidities	Wound Type	Number of Wounds	Wound Area (cm²) or Volume (cm³)	Severity of Wounds
Smith & Nephew Wound Management Unpublished Data (96)	132	Mean: 57, Range 20 - 92	73 M, 58F	NR	55: Surgical 14: Traumatic 29: Pressure ulcer 11: Diabetic foot ulcer 3: Leg ulcer 19: Graft site 1: Other	132	Median area: 25.6 cm², Range 1 cm²-1099.6 cm² Median depth: 1.5 cm, Range 0 cm-18 cm	21 clinically infection
Campbell et al. 2008 (84)	30	Mean: 72.3, Range: 32-96	9 M, 21 F	73%: Diabetes 40%: Venous disease 20%: Cancer 23%: RD	11: Chronic 11: Surgical dehiscence 8: Surgical incision	30	Median volume: 43.9 cm³ Area: 20.2 cm² Depth: 1.9 cm	NR
Gabriel et al. 2008 (383)	58	Median: 10 yrs, Range: 10 days-16 yrs	28 M 30 F	NR	Acute and chronic	18 trauma 17 abnormal 15 surgical soft tissue deficit 5 stage III/IV pressure ulcer 3 fasciotomy	Abdominal 120 cm³ Trauma 112 cm³ Pressure ulcer 60 cm³Soft tissue 150 cm³Fasciotomy 60 cm³	NR
Baharestani et al. 2007 (162)	24	Median: 11 yrs, Range: 14 days - 18 yrs	10 M, 14 F	NR	Leg, lumbar/sacral, abdomen, and chest wounds	9 leg 7 lumbar/sacral 4 abdomen 4 chest	6 traumatic: median baseline area 22.4 cm² 4 wounds treated were secondary to abdominal dehiscence: Median baseline area: 16.4 cm²	12 infected wounds
Ferron et al. 2007 (83)	11	Mean: 70.5 Range: 50-81	11 F	NR	10: Severe chest wall radionecrosis after breast cancer treatment 1: Locally advanced breast cancer	11	Mean: 360 cm² Range: 80-750 cm²	NR
Mendonca et al. 2007 (143)	26	Mean: 54, Range: 16-91	19 M 6 F	7: DM	Mechanical trauma, debridement of necrotic tissue, chronic	13 chronic 7 debridement of necrotic tissue 6 mechanical trauma	Mean: 55.23 ±55.24 cm²	NR
Wada et al. 2006 (384)	29	Mean: 59.8, Range: 29-78	18 M 11 F	13: DM 11: hypertension 10: CD 3: saphenectomy 2: vasculitis	Complex wounds	19 lower extremities 7 sacral ulcers 1 abdomen 1 breast 1 trunk	NR	NR
Adamkova et al. 2005 (152)	6	Range: 54-91	NR	CD hypertension, anemia	Subacute and chronic wounds	2 varicose ulcer lower extremity 2 loss of skin after an inflammation secondary to infection 1 high risk patient for deep burns 1 deep defect caused by inappropriate medical care	NR	NR
Butter et al. 2005 (144)	16	Avg: 12.1 yrs, Range: 1 month—18 yrs	7 M 9 F	NR	8 tissue loss after pilonidal sinus excision 3 wound dehiscence of the abdomen 2 sternum 1 back 1 leg 1 after chronic perineal fistula post-abdominoperineal resection	16	NR	NR
Caniano et al. 2005 (165)	51	Group 1: Avg: 16, Range: 10-20 Group 2, 3, 4: NR	NR	Group 1: 67% obese Group 2, 3, 4: NR	Group 1: pilonidal disease Group 2: sacral and extremity ulcers Group 3: traumatic soft tissue wounds Group 4: extensive tissue loss	Group 1: 21 Group 2: 9 Group 3: 9 Group 4: 12	NR	NR
Antony and Terrazas 2004 (385)	42	Sternal: 72 Lower extremity: 62 Spinal: 59	Sternal: 8 M, 4 F Spinal: 5 M, 11 F Lower extremity: NR	Sternal: all DM and CAD Lower extremity: 8 DM, CAD, and PVD Spine: 8 DM, Rheumatoid arthritis (RA), and spinal stenosis	Non-healing sternal, spinal, and lower extremity wounds	12 sternal with variety of infections 14 lower extremity w/ variety of infections 16 spinal	NR	NR
Bihariesingh et al. 2004 (386)	6	Mean: 60.2, Range: 33-76	3 M 3 F	NR	Complex soft-tissue defects following various orthopedic procedures	6	NR	NR
Loree et al. 2004 (387)	14	Median: 73, Range: 54-90	6 M, 8 F	NR	Chronic leg ulcers: 9 malleolar 3 foot 2 leg 1 tendon calcaneus	15	NR	Ulcer duration: 5 less than 6 months 6 between 6–24 months 4 between 24–360 months
Weed et al. 2004 (37)	25	NR	NR	DM	Acute: lower extremity, trauma, sternal wound, and elbow trauma Chronic: pressure ulcers and diabetic ulcers	26 V.A.C.® applications	NR	Serial quantitative cultures
Molnar et al. 2003 (388)	8	Mean: 40, Range: 2-60	NR	6: smokers 1: ovarian cancer, pulmonary embolus, chemo 1: DM and bladder cancer 1: CAD 1: hypertension	Complex wounds	5 trauma 2 wound dehiscence 1 tumor excision	Mean: 250 cm²	Bone exposed in 62.5% joint exposed in 50% tendon exposed in 37.5% bowel exposed in 25%
Schimp et al. 2003 (147)	27	Median: 51, Range: 21-77	27 F	BMI Median: 36 kg/m², Range: 14-62 6: smokers 8: history of radiation therapy 17: ≥2 abdominal surgeries 9: ≥2 comorbidities	Complex wound failures in gynecologic oncology patients	27	Median: 330 cm³, Range: 2-4,400 cm³	NR
Mooney et al. 2000 (79)	27	Range: 3 days - 18 years	14 M 13 F	NR	Acute extremity wounds, chronic extremity wounds, chronic axial wounds	27	NR	Acute extremity: wounds associated with open fractures considered too extensive for acute or delayed closure Chronic extremity: failed flap coverage, failed primary closure, extensive soft tissue and bony defects Chronic axial: abdominal or sternal dehiscence, myelodysplasia with compromised skin and soft tissue was treated for deep spinal wound infection
Wu et al. 2000 (158)	26	NR	17 M 9 F	NR	Chronic, acute, and subacute	8 acute 7 subacute 11 chronic	NR	NR
Argenta and Morykwas 1997 (148)	300	NR	NR	NR	Chronic wounds, subacute, and acute	175 chronic 94 subacute 31 acute	Venous stasis or other vasculitic ulcers: Range: 6-120 cm²	Subacute: 36 dehisced 37 open w/ exposed orthopedic hardware or bone, and other misc. wounds Acute: large soft tissue avulsions, contaminated wounds, hematomas, abscesses that were evacuated, gunshot wounds, eviscerations, extensive edema and contamination of exposed tissue
Mullner et al. 1997 (389)	Group A: 17	Group A: Mean: 82, Range: 71-88	Group A: 5 M, 12 F	NR	Group A: infected sacral pressure ulcers	Group A: 17	Group A: Mean: 43 cm³, Range: 12-72	Group A: 66% of patients the sacrum was exposed, more than 50% of wounds had active secretions
	Group B: 12	Group B: Mean: 35, Range: 24-58	Group B: 5 M, 7 F		Group B: acute soft tissue defects	Group B: 12	Group B: Mean: 20 cm³, Range: 6-80	Group B: 5 patients skin defect secondary to excision of necrotic skin overlying subcutaneous haematoma; 5 patients had deep infection and 30% of these had active secretions
	Group C: 16	Group C: Mean: 55, Range: 27-81	Group C: 10 M, 6 F		Group C: infected soft tissue defect involving exposed bone and/or implants	Group C: 16	Group C: Avg: 12 cm³, Range: 8-18

AF—Atrial Fibrillation
AS —Aortic Stenosis
CAD —Coronary Artery Disease
CAS —Carotid Artery Stenosis
CCF —Congestive Cardiac Failure
CD —Coronary Disease
CHD —Coronary Heart Disease
CHF —Congestive Heart Failure
CKD —Chronic Kidney Disease
CLD —Chronic Lung Disease
COPD—Chronic Obstructive Pulmonary Disease
CRF —Chronic Renal Failure
DM —Diabetes Mellitus
ESRD—End Stage Renal Disease
ESRF—End Stage Renal Failure
HF —Heart Failure
IDDM—Insulin Dependent Diabetes Mellitus
IHD —Ischaemic Heart Disease
MI —Myocardial Infarction
NIDDM—Non Insulin Dependent Diabetes Mellitus
NR —Not Reported
NS —Not Specified
PA —Peripheral Arteriopathy
PAD —Peripheral Arterial Disease
PAOD—Peripheral Artery Occlusive Disease
PVD—Peripheral Vascular Disease
RD —Renal Disease
RF —Renal Failure

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Table 36. Treatment Details for All Wound Types

Reference	Device	Dressing	Prior Treatments	Wound Preparation and Concurrent Treatments	Length of Follow-up (months)
Smith & Nephew Wound Management Unpublished Data (96)	VISTA™ or EZ-Care™ Smith and Nephew systems	Antimicrobial gauze, non-adherent gauze	NR	NR	7 days post treatment discontinuation
Baharestani et al. 2008 (93)	V.A.C.®	GranuFoam®	NR	NR	NR
Bannasch et al. 2008 (344)	V.A.C.®	NR	Doppler probe was placed against the drainage vein with the cuff secured around the vessel with nylon sutures, free flaps were split-skin grafted	Doppler probe	NR
Bapat et al. 2008 (153)	V.A.C.®	Polyurethane (PU) foam	NR	Debridement and antibiotics	Group A: Median: 23, Range: 12-35 Group B: Median: 17.5, Range: 6-21 Group C: Median: 22.5, Range: 13-34 Group D: Median: 16, Range: 7-22
Brandi et al. 2008 (345)	V.A.C.®	PU foam	Debridement, skin graft	Cryo-preserved homologous de-epidermalized dermis (DED)	Avg: 10 months
Campbell et al. 2008 (84)	VISTA™, or Versatile-1™, or EZ-Care™ Smith and Nephew systems	Saline moistened antimicrobial gauze	NR	NR	NR
Chen et al. 2008 (160)	V.A.C.®	PU foam	NR	Debridement, Median: 2 ±1, Range: 1-6	Median: 17, Range: 1-43
Dhir et al. 2008 (346)	V.A.C.®	Black V.A.C. GranuFoam® and white V.A.C. Vers-Foam®	NR	Incision, drainage, debridement; Hyperbaric oxygen treatment, dermal grafts, salivary diversion, regional flap reconstruction	NR
Ennker et al. 2008 (361)	V.A.C.®	NR	NR	Debridement	NR
Fleck et al. 2008 (362)	V.A.C.®	NR	NR	NR	NR
Gabriel et al. 2008 (383)	V.A.C.®	38: PU GranuFoam® 14: GranuFoam® silver dressing 6: abdominal dressing system Polyvinyl alcohol (PVA) foam under GranuFoam® in 3 fasciotomy cases	NR	NR	Mean: 12, Range: 3-34
Gdalevitch et al. 2008 (154)	V.A.C.®	Black PU foam	NR	NR	NR
Ha et al. 2008 (140)	V.A.C.®	NR	NR	Antibiotics	Median: 85 days, Range: 14-698 days
Hamed et al. 2008 (363)	V.A.C.®	PU foam sponge	Heavy dressings and bed rest	NR	Median: 12, Range: 4-32
Horch et al. 2008 (155)	V.A.C.®	PU sponge	Conservative treatment with repeated chemical debridement, 1 biologic debridement, and antibiotic therapy	Serial surgical debridement, general or spinal anesthesia for dressing changes or injection of 1% lidocaine	NR
Labanaris et al. 2008 (364)	V.A.C.®	NR	NR	Debridement and intravenous antibiotics	NR
Lopez et al. 2008 (365)	V.A.C.®	GranuFoam®	NR	NR	NR
Mokhtari et al. 2008 (366)	V.A.C.®	PU foam	NR	Debridement and irrigation	NR
Ploumis et al. 2008 (80)	V.A.C.®	NR	NR	Irrigation and debridement for treatment preparation and Intravenous antibiotics throughout treatment	Average: 14 Range: 12-28
Rhode et al. 2008 (347)	V.A.C.®	NR	4 patients had skin graft approximately 1 week after surgery from lateral thigh	Wound beds irrigated, debrided with sharp curette	Avg: 12.6, Minimum: 7
Rozen et al. 2008 (348)	Conventional disposable closed system suction drain w/ associated tubing¹	Disposable foam base	NR	Antibiotics	NR
Steiert et al. 2008 (349)	V.A.C.®	PU sponge	Fracture fixation	Initial debridement of necrotic tissue, perioperative antibiotic therapy minimum of 5 days	NR
Svensson et al. 2008 (149)	V.A.C.®	PU sponge	NR	NR	Median: 16
Wondberg et al. 2008 (161)	V.A.C.®	PU foam	NR	Antibiotic therapy	16 patients Median: 20.1, Range: 5-40
Baharestani et al. 2007 (162)	V.A.C.®	18: PU GranuFoam® 5: PVA 1: GranuFoam® silver	NR	7 chest wounds: white foam, Xeroform (2) and Vaseline gauze (5) 6 total parenteral nutrition (TPN) 3 received enteral feedings systemic antibiotic	NR
Bendewald et al. 2007 (82)	V.A.C.®	NR	NR	NR	Range: 6-14
Bendo et al. 2007 (76)	V.A.C.®	NR	NR	Antibiotics	NR
Bhattacharyya et al. 2007 (350)	V.A.C.®	NR	NR	Serial debridement approximately every 48 hrs, antibiotics from presentation to 48 hrs after definitive wound closure	Infected: 20.6 ±13.2, noninfected: 14 ±5.5
Bollero et al. 2007 (141)	V.A.C.®	NR	NR	Debridement	Avg: 265 days, Range: 33-874 days
Dedmond et al. 2007 (27)	V.A.C.®	NR	NR	Irrigation, debridement, antibiotics	Avg: 19.6
Ferron et al. 2007 (83)	V.A.C.®	PU foam	NR	NR	NR
Helgeson et al. 2007 (351)	V.A.C.®	NR	NR	Irrigation and debridement	NR
Horn et al. 2007 (78)	V.A.C.®	Vers-Foam® and GranuFoam® if necessary	NR	Debridements between dressing changes, sedation for dressing changes	NR
Jones et al. 2007 (150)	V.A.C.®	PU sponge	NR	Debridement & irrigation, antibiotics	At least 90 days
Kotsis and Lioupis 2007 (73)	V.A.C.®	NR	NR	NR	Mean: 17.2 Range: 1-28
Labler and Trentz 2007 (352)	V.A.C.®	PU foam	NR	Debridement, antibiotics	Avg: 19.8 ±1, Range: 7-38
Machen 2007 (74)	V.A.C.®	Black sponges	NR	NR	NR
McCord et al. 2007 (142)	V.A.C.®	White and black foam	NR	Debridement, intravenous analgesic or general anesthesia, or conscious sedation for dressing changes	Up to 7 months after negative pressure therapy start
Mendonca et al. 2007 (143)	V.A.C.®	NR	Chronic: debridement and topical destroying gels, regular moist wound healing dressing, maggot debridement therapy, compression bandaging for venous ulcers	Systemic antibiotics	NR
Peck et al. 2007 (353)	V.A.C.®	NR	NR	Debridement, operative washout (during) every 48-72 hours	NR
Perez et al. 2007 (95)	V.A.C.®	NR	NR	NR	Avg: 324 days Range: 70-445
Rao et al. 2007 (163)	V.A.C.®	GranuFoam®	NR	NR	NR
Segers et al. 2007 (354)	V.A.C.®	NR	NR	NR	Mean: 4.3 yrs, Range: 53-3,350 days
Senchenkov et al. 2007 (355)	V.A.C.®	NR	Skin grafting	Debridement	NR
Shrestha et al. 2007 (367)	V.A.C.®	NS	Percutaneous drainage of localized collections and regular change of dressings and antibiotics	NR	NR
Strecker et al. 2007 (318)	V.A.C.®	NR	NR	Radical debridement	23 ±13 months
van Rhee et al. 2007 (368)	V.A.C.®	NR	NR	Surgical debridement, antibiotics	Avg: 25 months, Range: 9-42
Andrews et al. 2006 (88)	V.A.C.®	PU foam	NR	Sharp debridement between dressings	NR
Cothren et al. 2006 (356)	V.A.C.®	Large black sponges and white sponges "Covering bowel with multiple white sponges overlapped like patchwork, and the fascia is placed under moderate tension over the white sponges with number 1-polydioxanone sutures"	Subfascial 1010 Steri Drape (3M healthcare), blue towel, or laparotomy pad coverage, Jackson Pratt (Bard) drain placement and Ioben (3M) coverage for temporary closure	NR	NR
DeFranzo et al. 2006 (156)	V.A.C.®	NR	NR	NR	28 had 2 yrs follow-up
Gorlitzer et al. 2006 (369)	V.A.C.®	NR	NR	Mediastinal necrosectomy	NR
Heller et al. 2006 (87)	V.A.C.®	PU and PVA foam	Saline soaked gauze dressings for 1-6 weeks	Debridement prior and during	At least 6
Labler et al. 2006 (370)	V.A.C.®	PU foam	Antibiotics, surgical interventions, implant removal/change	NR	14 patients Avg: 28.9, Range: 15-40
Leininger et al. 2006 (111)	V.A.C.®	Sponge	NR	Debridement & operative irrigation, pulsatile lavage	All patients scheduled for f/u in outpatient clinic for 1-12 weeks after discharge
Morgan et al. 2006 (164)	V.A.C.®	NR	Total contact casting, regular casting, negative pressure therapy, enzymatic debridement, resection of infected bone/soft tissue, mechanical debridement, placement of various biological dressings	NR	Avg: 13, Range: 1-21
Pelham et al. 2006 (371)	V.A.C.®	PU foam	NR	Irrigation and sharp surgical debridement; intravenous antibiotics	Mean: 24, Range: 14-32
Sartipy et al. 2006 (151)	V.A.C.®	PU foam	NR	NR	NR
Wada et al. 2006 (384)	V.A.C.®	NR	NR	NR	NR
Adamkova et al. 2005 (152)	V.A.C.®	Black PU sponge	NR	Debridement	NR
Agarwal et al. 2005 (372)	V.A.C.®	PU sponge	NR	Debridement, antibiotic	NR
Butter et al. 2005 (144)	V.A.C.®	Black or white sponge	8 pilonidal sinus 24-48 hours wet to dry dressings	NR	Avg: 8
Caniano et al. 2005 (165)	V.A.C.®	NR	NR	NR	Group 1: Avg: 13, Range: 8-36 Group 2, 3, 4: NR
Cowan et al. 2005 (373)	V.A.C.®	PU foam	NR	Irrigation & debridement, antibiotics	NR
Labler et al. 2005 (357)	V.A.C.®	PU foam	NR	NR	Range: 5-33
Lee et al. 2005 (374)	V.A.C.®	PU sponge	Conventional methods	Debridement	Mean: 35, Range: 5-70
Mendonca et al. 2005 (375)	V.A.C.®	Open-cell foam	Surgically debrided and wound dressing, amputation, antibiotics	Debridement	Avg: 6.3, Range: 1-18
Rosenthal et al. 2005 (89)	V.A.C.®	NR	NR	NR	Minimum: 5
Sjogren et al. 2005 (179)	V.A.C.®	NR	NR	NR	Avg: 2.7 ±1.7 patient years, Range: 0-5.8 patient years
Stoeckel et al. 2005 (358)	V.A.C.®	Foam	NR	NR	NR
Antony and Terrazas 2004 (385)	V.A.C.®	PU foam	NR	Operative and non-operative debridement, pulse lavage irrigation, antimicrobials	NR
Bihariesingh et al. 2004 (386)	V.A.C.®	Open-cell foam	Antibiotics and local wound management	Debridement	Mean: 514.8 days, Range: 246-693 days
Loree et al. 2004 (387)	V.A.C.®	PU ether, open-cell foam	Multiple treatment modalities (not specified) and had been treated with at least 3 other modern materials used for debridement	Debridement, analgesia	NR
Mehbod et al. 2004 (376)	V.A.C.®	NR	NR	Irrigation and debridement, antibiotic therapy	Avg: 10, Range: 6-24
O'Conner et al. 2004 (377)	V.A.C.®	NR	NR	Sedation and analgesia with dressing changes	Avg: 7, Range: 3-21
Routledge et al. 2004 (378)	V.A.C.®	PU foam and PVA foam	NR	Debridement and antibiotics	NR
Savolainen et al. 2004 (359)	V.A.C.®	Polyvinyl foam	NR	Anesthesia	NR
Scholl et al. 2004 (81)	V.A.C.®	PU foam	NR	NR	Mean: 14
Stone et al. 2004 (90)	V.A.C.®	NR	NR	NR	NR
Weed et al. 2004 (37)	V.A.C.®	NR	NR	Debridement	NR
Demaria et al. 2003 (145)	V.A.C.®	PU foam	Conventional therapies, polyvidone-iodine bandages, oral antimicrobial therapy	Surgical debridement, polyvidone-iodine applied & rinsed at dressing changes	NR
Gustafsson et al. 2003 (146)	V.A.C.®	PU foam	NR	Antibiotics	Median: 13, Range: 3- 41
Herscovici et al. 2003 (360)	V.A.C.®	PU ether sterile foam	NR	Surgical debridement	NR
Isago et al. 2003 (91)	V.A.C.®	PU foam	NR	NR	NR
Molnar et al. 2003 (388)	V.A.C.®	NR	NR	Integra incorporation (artificial skin substitute)	NR
Schimp et al. 2003 (147)	V.A.C.®	Black PU foam or white PVA soft foam	NR	NR	Mean: 52 days, Range: 0-270 days
Stonerock et al. 2003 (77)	V.A.C.®	PU foam	NR	NR	6
Suliburk et al. 2003 (166)	V.A.C.®	PU sponge	NR	Washed out at each dressing	NR
Wongworawat et al. 2003 (75)	V.A.C.®	PVA foam	NR	NR	NR
Armstrong et al. 2002 (85)	V.A.C.®	NR	NR	Sharp debridement	NR
Clare et al. 2002 (379)	V.A.C.®	Foam dressing	15 serial wound debridement, dressing changes, oral antibiotics 13 operative irrigation and debridement 6 revascularization procedures 5 had amputation	NR	NR
Fleck et al. 2002 (380)	V.A.C.®	PU foam	NR	Debridement, irrigation with 1 liter of dilute povidone-iodine solution (dressing changes), antibiotics	NR
Garner et al. 2001 (86)	V.A.C.®	PU foam	NR	NR	NR
Gustafsson et al. 2001 (381)	V.A.C.®	PU foam	NR	Antibiotics	At least 3 months
Hersh et al. 2001 (94)	V.A.C.®	PU sponge	NR	Debridement	NR
DeFranzo et al. 2000 (157)	V.A.C.®	Open-cell foam	NR	Debridement	Wounds have been stable from 6 months to 6 yrs
De Lange et al. 2000 (167)	V.A.C.®	Open-cell PU foam	NR	Debridement, local or systemic anesthetic (lidocaine 1%)	Range: 2-35
Deva et al. 2000 (382)	V.A.C.®	Foam	NR	NR	At least 3
Mooney et al. 2000 (79)	V.A.C.®	NR	NR	Conscious sedation or brief general anesthesia for dressing changes	NR
Avery et al. 2000 (92)	V.A.C.®	Opsite by Smith and Nephew	NR	NR	NR
Wu et al. 2000 (158)	V.A.C.®	PU or PVA foam	NR	Debridement, non steroidal anti-inflammatory drugs or morphine	NR
Lang et al. 1999 (159)	Vacuum sealing technique1	PVA	NR	Debridement	Avg: 13, Range: 3-35
Argenta and Morykwas 1997 (148)	V.A.C.®	PU ether foam	Dressing changes, topical treatments, surgical procedures	Debridement	NR
Mullner et al. 1997 (389)	V.A.C.®	PVA foam	Group A: wet to dry dressings Group B and C: irrigation, debridement & cultured, intravenous aminopenicillin and sulbactam 6.6 g per day for infected wounds or if cultures were positive, and wet to dry dressings	Group B: intravenous antibiotics	NR

Vacuum Assisted Closure (V.A.C.®) manufactured by KCI
¹ Manufacturer not specified
NR—Not reported
PU—Polyurethane
PVA—Polyvinyl alcohol

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Table 37. Outcomes Reported for All Wound Types

Reference	Duration of Treatment	Time to 50% Reduction of Initial Volume	Percent Change in Volume	Time to Complete Wound Closure	Percent of Wound Completely Healed	Healing of Infected Wounds	Reduction in Sepsis, Edema, or Amputation	Survival	Quality of Life/ Satisfaction with Treatment	Improved Wound Condition	Facilitation of Surgical Closure
Smith & Nephew Wound Management Unpublished Data (96)	X	X	X	X	X	X	X			X
Baharestani et al. 2008 (93)	X					X		X		X	X
Bannasch et al. 2008 (344)	X				X		X			X	X
Bapat et al. 2008 (153)	X					X				X	X
Brandi et al. 2008 (345)	X										X
Campbell et al. 2008 (84)	X	X	X		X					X
Chen et al. 2008 (160)	X				X	X		X		X	X
Dhir et al. 2008 (346)					X						X
Ennker et al. 2008 (361)	X										X
Fleck et al. 2008 (362)	X			X				X		X	X
Gabriel et al. 2008 (383)	X			X			X			X	X
Gdalevitch et al. 2008 (154)	X
Ha et al. 2008 (140)	X				X	X		X		X	X
Hamed et al. 2008 (363)	X				X					X
Horch et al. 2008 (155)				X		X			X	X	X
Labanaris et al. 2008 (364)	X						X				X
Lopez et al. 2008 (365)	X			X				X		X
Mokhtari et al. 2008 (366)						X		X			X
Ploumis et al. 2008 (80)	X			X	X	X				X
Rhode et al. 2008 (347)	X				X					X	X
Rozen et al. 2008 (348)	X										X
Steiert et al. 2008 (349)	X			X						X	X
Svensson et al. 2008 (149)	X			X	X	X		X		X	X
Wondberg et al. 2008 (161)	X			X			X		X	X	X
Baharestani et al. 2007 (162)	X			X	X	X				X	X
Bendewald et al. 2007 (82)	X			X	X					X
Bendo et al. 2007 (76)	X			X
Bhattacharyya et al. 2007 (350)				X		X				X	X
Bollero et al. 2007 (141)	X				X					X	X
Dedmond et al. 2007 (27)	X			X	X	X				X	X
Ferron et al. 2007 (83)	X			X	X	X	X	X	X	X	X
Helgeson et al. 2007 (351)				X			X			X	X
Horn et al. 2007 (78)	X			X		X				X
Jones et al. 2007 (150)	X										X
Kotsis and Lioupis 2007 (73)	X				X		X
Labler and Trentz 2007 (352)	X					X				X	X
Machen 2007 (74)					X	X	X			X	X
McCord et al. 2007 (142)	X	X	X				X			X	X
Mendonca et al. 2007 (143)	X	X	X		X	X			X	X	X
Peck et al. 2007 (353)				X						X	X
Perez et al. 2007 (95)	X							X	X	X	X
Rao et al. 2007 (163)	X
Segers et al. 2007 (354)	X			X				X
Senchenkov et al. 2007 (355)	X			X	X					X	X
Shrestha et al. 2007 (367)	X				X	X				X
Strecker et al. 2007 (318)	X					X				X	X
van Rhee et al. 2007 (368)				X		X				X
Andrews et al. 2006 (88)	X									X	X
Cothren et al. 2006 (356)				X						X
DeFranzo et al. 2006 (156)	X			X	X	X		X		X	X
Gorlitzer et al. 2006 (369)	X									X	X
Heller et al. 2006 (87)	X						X			X	X
Labler et al. 2006 (370)	X			X	X	X				X	X
Leininger et al. 2006 (111)				X		X				X	X
Morgan et al. 2006 (164)					X					X	X
Pelham et al. 2006 (371)	X			X	X	X				X	X
Sartipy et al. 2006 (151)	X							X
Wada et al. 2006 (384)	X			X						X	X
Adamkova et al. 2005 (152)	X			X	X	X	X			X	X
Agarwal et al. 2005 (372)	X					X				X	X
Butter et al. 2005 (144)	X			X	X					X	X
Caniano et al. 2005 (165)	X				X					X	X
Cowan et al. 2005 (373)	X	X	X	X		X	X	X		X	X
Labler et al. 2005 (357)	X			X		X	X	X		X	X
Lee et al. 2005 (374)	X			X	X	X				X	X
Mendonca et al. 2005 (375)			X		X	X	X			X	X
Rosenthal et al. 2005 (89)	X									X	X
Sjogren et al. 2005 (179)								X
Stoeckel et al. 2005 (358)	X				X					X	X
Antony and Terrazas 2004 (385)	X			X		X				X
Bihariesingh et al. 2004 (386)	X			X						X	X
Loree et al. 2004 (387)	X		X							X
Mehbod et al. 2004 (376)	X			X						X	X
O'Conner et al. 2004 (377)	X				X	X				X	X
Routledge et al. 2004 (378)	X				X	X				X
Savolainen et al. 2004 (359)	X				X	X				X	X
Scholl et al. 2004 (81)	X			X	X	X				X	X
Stone et al. 2004 (90)				X			X	X		X	X
Weed et al. 2004 (37)	X				X	X				X	X
Demaria et al. 2003 (145)	X				X	X				X	X
Gustafsson et al. 2003 (146)	X
Herscovici et al. 2003 (360)	X										X
Isago et al. 2003 (91)	X		X			X	X			X	X
Molnar et al. 2003 (388)	X									X	X
Schimp et al. 2003 (147)	X		X		X					X	X
Stonerock et al. 2003 (77)	X			X			X			X
Suliburk et al. 2003 (166)	X			X						X
Wongworawat et al. 2003 (75)	X		X							X
Armstrong et al. 2002 (85)	X			X			X			X
Clare et al. 2002 (379)	X				X					X	X
Fleck et al. 2002 (380)	X				X	X		X		X	X
Garner et al. 2001 (86)	X									X
Gustafsson et al. 2001 (381)	X			X		X				X	X
Hersh et al. 2001 (94)	X					X		X		X	X
DeFranzo et al. 2000 (157)						X	X			X	X
De Lange et al. 2000 (167)	X				X	X	X			X	X
Deva et al. 2000 (382)	X	X	X		X	X				X	X
Mooney et al. 2000 (79)										X	X
Avery et al. 2000 (92)	X									X	X
Wu et al. 2000 (158)	X					X					X
Lang et al. 1999 (159)	X			X	X	X				X	X
Argenta and Morykwas 1997 (148)	X		X	X	X	X	X			X	X
Mullner et al. 1997 (389)	X		X	X	X	X	X			X	X

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Table 38. Adverse Events Reported for All Wound Types

Reference	Pain	Bleeding	Infection/ Bacterial Load	Mortality	Other Complications
Smith & Nephew Wound Management Unpublished Data (96)			X
Baharestani et al. 2008 (93)
Bannasch et al. 2008 (344)
Bapat et al. 2008 (153)			X	X
Brandi et al. 2008 (345)
Campbell et al. 2008 (84)
Chen et al. 2008 (160)					X
Dhir et al. 2008 (346)
Ennker et al. 2008 (361)
Fleck et al. 2008 (362)
Gabriel et al. 2008 (383)
Gdalevitch et al. 2008 (154)			X
Ha et al. 2008 (140)	X				X
Hamed et al. 2008 (363)
Horch et al. 2008 (155)			X
Labanaris et al. 2008 (364)
Lopez et al. 2008 (365)
Mokhtari et al. 2008 (366)
Ploumis et al. 2008 (80)
Rhode et al. 2008 (347)
Rozen et al. 2008 (348)
Steiert et al. 2008 (349)
Svensson et al. 2008 (149)		X	X	X
Wondberg et al. 2008 (161)					X
Baharestani et al. 2007 (162)					X
Bendewald et al. 2007 (82)					X
Bendo et al. 2007 (76)
Bhattacharyya et al. 2007 (350)
Bollero et al. 2007 (141)	X
Dedmond et al. 2007 (27)
Ferron et al. 2007 (83)
Helgeson et al. 2007 (351)
Horn et al. 2007 (78)	X
Jones et al. 2007 (150)		X	X	X
Kotsis and Lioupis 2007 (73)
Labler and Trentz 2007 (352)
Machen 2007 (74)
McCord et al. 2007 (142)	X	X			X
Mendonca et al. 2007 (143)	X
Peck et al. 2007 (353)
Perez et al. 2007 (95)					X
Rao et al. 2007 (163)					X
Segers et al. 2007 (354)
Senchenkov et al. 2007 (355)
Shrestha et al. 2007 (367)
Strecker et al. 2007 (318)
van Rhee et al. 2007 (368)
Andrews et al. 2006 (88)	X
Cothren et al. 2006 (356)
DeFranzo et al. 2006 (156)			X
Gorlitzer et al. 2006 (369)
Heller et al. 2006 (87)					X
Labler et al. 2006 (370)
Leininger et al. 2006 (111)
Morgan et al. 2006 (164)					X
Pelham et al. 2006 (371)
Sartipy et al. 2006 (151)		X		X
Wada et al. 2006 (384)
Adamkova et al. 2005 (152)		X
Agarwal et al. 2005 (372)
Butter et al. 2005 (144)	X				X
Caniano et al. 2005 (165)					X
Cowan et al. 2005 (373)
Labler et al. 2005 (357)
Lee et al. 2005 (374)
Mendonca et al. 2005 (375)
Rosenthal et al. 2005 (89)
Sjogren et al. 2005 (179)
Stoeckel et al. 2005 (358)
Antony and Terrazas 2004 (385)
Bihariesingh et al. 2004 (386)
Loree et al. 2004 (387)
Mehbod et al. 2004 (376)
O'Conner et al. 2004 (377)
Routledge et al. 2004 (378)
Savolainen et al. 2004 (359)
Scholl et al. 2004 (81)
Stone et al. 2004 (90)					X
Weed et al. 2004 (37)			X
Demaria et al. 2003 (145)	X
Gustafsson et al. 2003 (146)	X				X
Herscovici et al. 2003 (360)
Isago et al. 2003 (91)	X
Molnar et al. 2003 (388)
Schimp et al. 2003 (147)	X	X
Stonerock et al. 2003 (77)			X
Suliburk et al. 2003 (166)					X
Wongworawat et al. 2003 (75)
Armstrong et al. 2002 (85)			X		X
Clare et al. 2002 (379)
Fleck et al. 2002 (380)
Garner et al. 2001 (86)			X
Gustafsson et al. 2001 (381)
Hersh et al. 2001 (94)
DeFranzo et al. 2000 (157)			X
De Lange et al. 2000 (167)					X
Deva et al. 2000 (382)
Mooney et al. 2000 (79)		X
Avery et al. 2000 (92)
Wu et al. 2000 (158)			X
Lang et al. 1999 (159)			X
Argenta and Morykwas 1997 (148)	X		X		X
Mullner et al. 1997 (389)

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Systematic Reviews of NPWT Devices

Table 39. Characteristics of Systematic Reviews of NPWT Devices—High Quality Reviews

Citation	Objective	Search Strategy	Key Inclusion/ Exclusion Criteria	Evidence Base/ Method of Assessing Study Quality	Participant Characteristics	Outcomes Assessed	Results and/or Authors' Conclusions
Gregor et al. 2008 (173) Negative Pressure Wound Therapy: A Vacuum of Evidence?	To systematically examine the clinical effectiveness and safety of NPWT compared with conventional wound therapy	Searches were completed in MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials. Systematic reviews were identified by searching the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, and the HTA Database thru October 2005. The U.S. F.D.A., other health agencies, clinical experts, and 2 manufacturers were asked to provide clinical data.	Included RCTs and non-RCTs if they had a concurrent control group and evaluated the effect of NPWT versus conventional wound therapy on wound healing. All languages were included. Abstracts were excluded if 2 investigators classified them as not relevant or if not available as full-text articles.	Studies: 7 RCTs 10 non-RCTs Comparators: Standard of care. Healthpoint System. Bolster dressing. OpSite N = 602 Wounds = 667 Quality Assessment: IQWIG Steering Committee Methods (2006)	Patients with the following wound types: Diabetic foot amputations. Chronic diabetic wounds. Pressure ulcers. Chronic wounds. Skin grafts. Open wounds/abdomen. Infected sternotomy. Acute burns.	Included: Incidence of complete wound closure Time to wound closure	Authors reported benefit to patients treated with NPWT for surrogate variables of wound healing. Firstly, a significant advantage in favor of NPWT was reported in 4 of 7 studies reporting wound closure. Secondly, pooled data from 6 studies showed a significant reduction in wound size in favor of NPWT. In addition, 1 large RCT (Armstrong) reported a significantly faster rate of generation of granulation tissue in patients treated with NPWT. Despite these favorable results, overall evidence was insufficient to clearly prove an additional clinical benefit of NPWT.
Ubbink et al. 2008* (174) Topical negative pressure for treating chronic wounds	To assess the effects of NPWT on chronic wound healing	Studies were identified by searching Cochrane Wounds Group Specialised Register (searched 12/17/07), the Cochrane Central Register of Controlled Trials, Ovid MEDLINE (1950 to November 2007), Ovid EMBASE (1982 to 2007), and Ovid CINAHL (1980 to December 2007) databases. Reference lists of identified studies were searched as well as offer to Kinetic Concepts to submit unpublished or ongoing trials.	All RCTs evaluating the effects of NPWT on patients with chronic wounds and reporting at least one of the following outcomes: Time to complete healing. Rate of change in wound area and/or volume. Proportion of wounds completely healed. Time to surgical readiness. Survival rate (risk of graft failure) of split-thickness skin grafts.	Studies: 7 RCTs Comparators: Soaked gauze in either 0.9% saline or Ringer's solution (k = 4). Hydrocolloid gel plus gauze (k = 1). Papain-urea topical (k = 1). Cadexomer iodine or hydrocolloid, hydrogels, alginate and foam (k = 1). N = 205 Quality Assessment: Based on the Dutch Cochrane Collaboration checklist	Patients with the following wound types: Non-healing ulcers. Diabetic foot ulcers. Wound management before surgical closure. Pressure ulcers. Soft tissue defects. Full-thickness pressure ulcers. Chronic ulcers.	Outcomes included: Time to complete healing. Change in wound surface area or volume. Time to surgical readiness.	Authors conclude no significant benefit was shown in the treatment of chronic wounds with NPWT when compared to moistened gauze dressings or other topical agents. The methodological quality of the studies was rated poor due to small study populations, unclear allocation methods, lack in blinding of outcome assessors, and short duration of follow-up The authors recommend upcoming trials should focus on more patient relevant outcomes such as time to complete wound healing; use validated measures when documenting QOL, pain, or comfort; and include longer term follow-up.
Wasiak and Cleland 2007 (172) Topical negative pressure (TNP) for partial thickness burns	To assess the effectiveness of NPWT for those people with partial thickness burns	The Cochrane Wounds Group Specialised Register, the Cochrane Central Register of Controlled Trials, Ovid MEDLINE (1950 to April 2007), Ovid EMBASE (1980 to Week 18 2007) and Ovid CINAHL (1982 to April 2007); and hand searches of retrieved studies were undertaken for identifiable studies. Contact was made with authors of relevant studies to submit details of unpublished or ongoing investigations.	All RCTs and controlled clinical trials involving adults aged 18 years or older with partial thickness burns and evaluating the effectiveness of topical negative pressure (NPWT) were included.	Study: 1 RCT Comparator: Silver sulphadiazine (SSD) N = 20 Quality Assessment: based on the method outlined by Schultz (1995)	Patients aged 20-70 years with total burn surface areas ranging from 5-401% with bilateral thermal hand burns treated less than 24 hours.	Rate of change in wound area and treatment complications	Preliminary data from one study of 20 patients (serving as their own controls). Patients were randomized to receive either a 48 hour treatment of NPWT or silver sulphadiazine. A significant difference in burn size at days 3 and day 5 was reported however no difference was reported at day 14 for NPWT treatment. Methods of randomization and allocation concealment, as well as absence of reporting on clinically relevant outcomes were noted as study shortcomings. The Molnar study was reported as methodologically poor however this assessment was limited to the available text in the abstract.

Citation

Objective

Search Strategy

Key Inclusion/ Exclusion Criteria

Evidence Base/
Method of Assessing Study Quality

Participant Characteristics

Outcomes Assessed

Results
and/or Authors' Conclusions

Gregor et al. 2008 (173)

Negative Pressure Wound Therapy: A Vacuum of Evidence?

To systematically examine the clinical effectiveness and safety of NPWT compared with conventional wound therapy

Searches were completed in MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials. Systematic reviews were identified by searching the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, and the HTA Database thru October 2005. The U.S. F.D.A., other health agencies, clinical experts, and 2 manufacturers were asked to provide clinical data.

Included RCTs and non-RCTs if they had a concurrent control group and evaluated the effect of NPWT versus conventional wound therapy on wound healing. All languages were included.

Abstracts were excluded if 2 investigators classified them as not relevant or if not available as full-text articles.

Studies:
7 RCTs
10 non-RCTs

Comparators:

Standard of care.
Healthpoint System.
Bolster dressing.
OpSite

N = 602
Wounds = 667

Quality Assessment: IQWIG Steering Committee Methods (2006)

Patients with the following wound types:

Diabetic foot amputations.
Chronic diabetic wounds.
Pressure ulcers.
Chronic wounds.
Skin grafts.
Open wounds/abdomen.
Infected sternotomy.
Acute burns.

Included:

Incidence of complete wound closure
Time to wound closure

Authors reported benefit to patients treated with NPWT for surrogate variables of wound healing. Firstly, a significant advantage in favor of NPWT was reported in 4 of 7 studies reporting wound closure. Secondly, pooled data from 6 studies showed a significant reduction in wound size in favor of NPWT. In addition, 1 large RCT (Armstrong) reported a significantly faster rate of generation of granulation tissue in patients treated with NPWT.

Despite these favorable results, overall evidence was insufficient to clearly prove an additional clinical benefit of NPWT.

Ubbink et al. 2008* (174)

Topical negative pressure for treating chronic wounds

To assess the effects of NPWT on chronic wound healing

Studies were identified by searching Cochrane Wounds Group Specialised Register (searched 12/17/07), the Cochrane Central Register of Controlled Trials, Ovid MEDLINE (1950 to November 2007), Ovid EMBASE (1982 to 2007), and Ovid CINAHL (1980 to December 2007) databases.

Reference lists of identified studies were searched as well as offer to Kinetic Concepts to submit unpublished or ongoing trials.

All RCTs evaluating the effects of NPWT on patients with chronic wounds and reporting at least one of the following outcomes:

Time to complete healing.
Rate of change in wound area and/or volume.
Proportion of wounds completely healed.
Time to surgical readiness.
Survival rate (risk of graft failure) of split-thickness skin grafts.

Studies:
7 RCTs

Comparators:

Soaked gauze in either 0.9% saline or Ringer's solution (k = 4).
Hydrocolloid gel plus gauze (k = 1).
Papain-urea topical (k = 1).
Cadexomer iodine or hydrocolloid, hydrogels, alginate and foam (k = 1).

N = 205

Quality Assessment:
Based on the Dutch Cochrane Collaboration checklist

Patients with the following wound types:

Non-healing ulcers.
Diabetic foot ulcers.
Wound management before surgical closure.
Pressure ulcers.
Soft tissue defects.
Full-thickness pressure ulcers.
Chronic ulcers.

Outcomes included:

Time to complete healing.
Change in wound surface area or volume.
Time to surgical readiness.

Authors conclude no significant benefit was shown in the treatment of chronic wounds with NPWT when compared to moistened gauze dressings or other topical agents.

The methodological quality of the studies was rated poor due to small study populations, unclear allocation methods, lack in blinding of outcome assessors, and short duration of follow-up

The authors recommend upcoming trials should focus on more patient relevant outcomes such as time to complete wound healing; use validated measures when documenting QOL, pain, or comfort; and include longer term follow-up.

Wasiak and Cleland 2007 (172)

Topical negative pressure (TNP) for partial thickness burns

To assess the effectiveness of NPWT for those people with partial thickness burns

The Cochrane Wounds Group Specialised Register, the Cochrane Central Register of Controlled Trials, Ovid MEDLINE (1950 to April 2007), Ovid EMBASE (1980 to Week 18 2007) and Ovid CINAHL (1982 to April 2007); and hand searches of retrieved studies were undertaken for identifiable studies.

Contact was made with authors of relevant studies to submit details of unpublished or ongoing investigations.

All RCTs and controlled clinical trials involving adults aged 18 years or older with partial thickness burns and evaluating the effectiveness of topical negative pressure (NPWT) were included.

Study:
1 RCT

Comparator:
Silver sulphadiazine (SSD)

N = 20

Quality Assessment: based on the method outlined by Schultz (1995)

Patients aged 20-70 years with total burn surface areas ranging from 5-401% with bilateral thermal hand burns treated less than 24 hours.

Rate of change in wound area and treatment complications

Preliminary data from one study of 20 patients (serving as their own controls). Patients were randomized to receive either a 48 hour treatment of NPWT or silver sulphadiazine. A significant difference in burn size at days 3 and day 5 was reported however no difference was reported at day 14 for NPWT treatment.

Methods of randomization and allocation concealment, as well as absence of reporting on clinically relevant outcomes were noted as study shortcomings.

The Molnar study was reported as methodologically poor however this assessment was limited to the available text in the abstract.

HTA = Health technology assessment
* Reports contain duplicate studies however one report focuses on chronic wounds (174) and excludes 5 studies.

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Table 39a. Characteristics of Systematic Reviews of NPWT Devices—Moderate Quality Reviews

Citation	Objective	Search Strategy	Key Inclusion/ Exclusion Criteria	Evidence Base/ Method of Assessing Study Quality	Participant Characteristics	Outcomes Assessed	Results and/or Authors' Conclusions
Schimmer et al. 2008 (175) Management of post-sternotomy mediastinitis: experience and results of different therapy modalities	To provide an overview of current literature referring to the primary treatment of post-sternotomy mediastinitis, and to outline the treatment options used in all 79 German heart centers	A systematic search of the MEDLINE database from years 2000-2006 for text written in English or German. A questionnaire distributed from November 2006 to January 2007 to 79 German heart centers.	Articles including “treatment of deep sternal wound infection” and “post-sternotomy mediastinitis” and including an overview of V.A.C.® therapy or referring to both V.A.C.® therapy and primary closure with suction/irrigation systems.	Studies: 2 retrospective 8 non-randomized comparisons Comparators: Primary closure with suction/ irrigation systems. Removal of the sternum and a thoracic closure by means of plastic reconstruction (k = 1). N = 611 Quality Assessment: NR	Patients with post-sternotomy mediastinitis (PM)	Mortality. Recurrence rate. Overall survival. Quality of life (QOL). Hospital stay. Treatment failure. Infection.	This review included 2 retrospective studies evaluating V.A.C.® therapy and 8 non-randomized comparisons evaluating use of V.A.C.® and primary sternal closure, with a closed mediastinal catheter suction/irrigation system. Benefits to treatment with V.A.C.® included less treatment failure, shorter postoperative stay, lower rates of recurring infection, improved QOL, and increase in overall survival. Study flaws mentioned include the lack of differentiation of patients according to PM types, small study populations, and the lack of randomized trials.
Ubbink et al. 2008* (183) A systematic review of topical negative pressure therapy for acute and chronic wounds	To summarize up-to-date, high-level evidence on the effectiveness of NPWT on wound healing, in both acute and chronic settings	A search of the following databases: CINAHL, EMBASE and MEDLINE to June 2007 and the Cochrane controlled trials register to issue 4, 2007. One manufacturer, (Kinetic Concepts, Inc.) was contacted to submit unpublished articles.	RCTs evaluating the use and effectiveness of NPWT in patients aged 18 years and over with wounds with various etiologies. Included trials assessed wound healing as primary endpoint; also assessed change in wound surface area, proportion of wounds healed within the trial period, survival rate of split-thickness skin grafts or wound condition ready for surgery or skin grafting. Secondary endpoints were infection, pain, quality of life, edema, microcirculation, bacterial load, adverse events and duration of hospital stay.	Studies: 13 RCTs Comparators: Soaked gauze in either 0.9% saline or Ringer's solution. Hydrocolloid gel plus gauze. Papain-urea topical. Cadexomer iodine or hydrocolloid, hydrogels, alginate and foam. Compression dressing. Bolster dressing. N = 554 patients (573 wounds) Quality Assessment: Based on the Dutch Cochrane Collaboration checklist	Patients with the following wound types: Chronic (venous, arterial, diabetic or pressure. Acute including split skin grafts.	See inclusion criteria.	In this review, Ubbink and co-investigators evaluated the use of NPWT in the treatment of chronic and acute wounds. The authors conclude that there is "no worthwhile evidence to support the use of NPWT in the treatment of various wounds."
van den Boogaard et al. 2008 (107) The effectiveness of topical negative pressure in the treatment of pressure ulcers: a literature review	To gain insight into the effectiveness of NPWT in the treatment of pressure ulcers	A systematic search of MEDLINE, EMBASE, and CINAHL databases was undertaken. There were no language or publication restrictions.	Randomized controlled clinical studies evaluating the effect of topical negative pressure (TNP) compared to a control intervention in patients with pressure ulcers were included. Key inclusion criteria also included: A group of examined patients consists entirely or partly of patients with pressure ulcers The outcome measurement is in any case wound healing in terms of volume and or surface reduction or increase in granulation tissue The control intervention has been described.	Studies: 5 RCTs Comparators: Healthpoint System (k = 1). Standard of care (k = 3). Various dressings (k = 1). N = 19 Quality Assessment: Dutch Cochrane quality criteria for RCTs	Patients with pressure ulcers	Outcomes included: Wound volume. Wound healing. Granulation tissue formation. Wound surface. Cost.	2 RCTs only including patients with pressure sores found no significant differences for wound healing. Remaining 3 studies examining wounds with different etiologies found significant differences in wound healing specifically in the decrease of wound treatment time. Study authors conclude that topical negative pressure wound therapy has not proven to be more effective than various control interventions.
Vikatmaa et al. 2008 (178) Negative Pressure Wound Therapy: a Systematic Review on Effectiveness and Safety	To review the use of NPWT for problematic wounds	Literature searches of Medline, Medline in-progress, PubMed and Cochrane Controlled Trials Register from 1996. Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effectiveness, NHS Economic Evaluation Database, and Health Technology Assessment Database; Cliniclaltrials.gov, National Research Register and meta Register; Aggressive Research Intelligence Facility and manufacturers Web sites were also searched. Searches undertaken in July 2006 and updated in January 2008.	RCT in which NPWT was compared with any other local wound therapy for any wound indication were included.	Studies: 14 RCTs Comparators: Healthpoint System. Gauze soaked with Ringer's. Standard of care. Hydrocolloids, foams or hydrogels, alginates. Pressure dressing. Mepitel® silicone-dressing. Quality Assessment: Method according to Samson et al. (182)	Patients with the following wound types: Pressure. Post-traumatic. DFU. Chronic.	Primary outcomes included: Total healing. Time to halve the wound volume. Time to reach minimal incision drainage. Area of skin graft loss. 100% re-epithelialization before 112 days. Wound volume decrease. Definitive closure. Wound healing time.	NPWT appears to be a safe alternative treatment and is at least as good as or better than current local treatment for wounds. The effectiveness of NPWT is clearly warranted in the treatment of chronic leg ulcers and post-traumatic ulcers. A majority of the studies were classified as having poor internal validity.
Costa et al. 2005 (modified 2007) (181) Vacuum-assisted wound closure therapy (V.A.C.®) McGill University Health Centre (MUHC) Technology Assessment Unit (TAU)		Articles published through March 27, 2005 in PubMed, EMBASE, Cochrane Database of Systematic Reviews, and CHSPR, ICES, MCHP, and INAHTA databases published in English/French. Hand searches of reference lists of clinical studies, systematic reviews, and technology assessment reports were also undertaken.	Comparative clinical and economic studies, or systematic reviews	Studies: 4 RCTs 2 non-randomized prospective 1 cross-over with subjects receiving a randomly selected alternate 2 week treatment 1 trial in which different halves of wounds received V.A.C.® and moist dressing treatment 5 retrospective reviews 1 systematic review (N not reported) Comparators: Standard of care. OpSite. Total study population reported by: Patients = 312 Wounds = 96 Quality Assessment: NR	Patients aged 4-81 years with the following wound types: Decubitus ulcers. Diabetic foot. Skin graft. Pressure sores. Lawnmower injuries. Post-sternotomy osteomyelitis. Sternal. Post-sternotomy mediastinitis.	Included: Wound area. Wound volume/ depth. Complete healing. Graft appearance. Time to surgery. Hospital stay. % graft take. N requiring free flap. Treatment duration. Treatment failure.	Authors conclude there is insufficient evidence to recommend the routine use of V.A.C.® therapy. Study results are inconsistent although the more credible evidence suggested no benefit from V.A.C.® therapy. Additional study weaknesses include small and possible heterogeneity of patient populations, inadequate reporting of baseline wound dimensions, and high attrition rates.
Kanakaris et al. 2007 (25) The efficacy of negative pressure wound therapy in the management of lower extremity trauma: Review of clinical evidence	To present the existing clinical evidence on the usefulness of NPWT in the acute setting of lower limb trauma	A search was undertaken of Medline and OVID through 1/08/07.	Studies evaluating NPWT in the acute phase (1st week) of lower limb trauma were included. Studies including less than 6 patients; studies in non-English languages; and manuscripts that evaluated clinical applications in different clinical conditions were excluded.	Studies: Acute lower limb trauma 1 RCT 1 prospective comparative 1 retrospective comparative 8 case series Burn wounds 1 RCT 2 non-randomized controlled trials 2 case series Comparators: SSD. Standard of care. N = 430 Quality Assessment: NR	Patients with acute lower limb trauma and burn wounds	Outcomes included: Time to closure. Complications. Hospitalization stay.	Based on evidence from a limited number of controlled trials, authors recommend the use of NPWT in the acute phase of blunt, penetrating and thermal trauma of the extremities.
Vlayen et al. 2007 (180) Vacuumgeassisteerde Wondbehandeling: een Rapid Assessment	To provide a clear synthesis of the evidence on the clinical effectiveness, safety and cost-effectiveness of NPWT	HTA database, Cochrane Library [OVID], Medline [OVID], Pre-Medline [OVID], Embase [Embase.com], Cinahl [OVID], and British Nursing Index [OVID] were searched. Grey literature was accessed via Google and with contact by suppliers and manufacturers.	HTA, systematic reviews, meta-analysis, and RCTs; use of subatmospheric pressure for the treatment of acute or chronic wounds; major outcomes of interest: wound closure, adverse events, and health-related quality of life were included. Excluded were narrative reviews, letters, commentaries, case series, case studies; articles on primary closed wound drainage, the sandwich-vacuum pack technique, etc. and target conditions other than mentioned above.	Studies: 7 HTAs. 15 RCTs. 5 SRs. Comparators: Modified NPWT system. Healthpoint System. Gauze (saline or Ringers). Bolster dressing. Conventional grafting. Standard of care. N = 726 Quality Assessment: INAHTA checklist to assess HTA reports and Dutch Cochrane Centre checklist for SRs and RCTs	Patients with the following wound types: Traumatic. DFU. Pressure ulcers. Skin grafts. Complex and traumatic. Other.	Outcomes included: Time to complete healing. Time to recurrence. % graft loss. Change in amount of wound surface. Total nursing time. Complete wound closure. Second amputation. Surgical readiness.	Previously identified HTA and SR authors reported that the evidence to-date did not justify widespread use of NPWT. The study authors concluded that the newly available evidence did not allow them to make a clear statement about the clinical efficacy and safety of NPWT. RCT study flaws included low methodological quality and small patient populations. Of the 15 RCTs reviewed, only 2 were found to be of moderate quality while none were considered to be of good quality. With the exception of one study (Armstrong, n = 162), study populations ranged from 10 to 65 patients.
Ontario Health Technology Advisory Committee (OHTAC) 2006 (184) Negative Pressure Wound Therapy: Update	To update a 2004 report from the Medical Advisory Secretariat's (MAS) which concluded that no additional funding be provided for V.A.C.® therapy	MEDLINE, EMBASE, MEDLINE In-Process and Non-Indexed Citations, INAHTA, Cochrane Database of Systematic Reviews, and a vacuum therapy Web Site (http://www.vacuumtherapo.co.uk/index.htm) were searched.	Peer-reviewed, published RCTs with sample size of 20 or more patients involved in a human study analyzing negative pressure wound therapy were included. Non-randomized trials were excluded.	Studies: 6 RCTs Comparators: Standard of care (k = 3). Healthpoint System (k = 1). Saline gauze (k = 1). Bolster dressing (k = 1). N = 346 Quality Assessment: Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria	Patients with mean age ranging between 42 and 64 years with the following wound types: Surgical wounds after amputation (k = 1). Non-healing wounds (k = 2). Decubitus ulcers (k = 2). Pressure sores (k = 1).	Outcomes included: Wound area. Wound volume. Complete wound closure.	This report's recommendation was based on 1 highly rated RCT due to the “low” or “very low” quality rating of the remaining 5 RCTs. Armstrong & Lavery, a 16 week multicentre study, included 162 patients who had acute, surgical wounds from partial foot amputations and were randomized to NPWT or standard care. In addition some underwent surgical wound closure. OHTAC concludes there was not a statistically significant difference between NPWT and standard care in the rate of complete wound closure in patients who had complete wound closure but did not undergo surgical wound closure. It was not possible to discuss whether or not NPWT decreased the time to complete wound closure due to the lack of reporting on this outcome for patients who did not undergo surgical wound closure.
Pham et al. 2006 (176) The safety and efficacy of topical negative pressure in non-healing wounds: a systematic review	To compare the efficacy and safety outcomes of NPWT with those of conventional methods in treating particular wound types	Medline, PreMEDLINE, Embase, Current Contents, PubMed and Cochrane Library were searched for articles published until October 2004. The York (UK) Centre for Reviews and Dissemination databases, clinicaltrials.gov, National Research Register, Grey Literature Reports, relevant online journals and Internet were searched in October 2004. Searches were again performed in July 2005 for new RCTs.	Articles were chosen if the abstract included safety and efficacy data in the form of RCTs, other controlled or comparatives studies, or case series with consecutive patients; and if wound type was stated. If relevant safety and efficacy data was present then conference abstracts, manufacturers information, and English abstracts from foreign-language articles was also included.	Studies: 2 SRs. 10 RCTs. 4 non-randomized comparative. 7 case series. Comparators: Gauze. Healthpoint System. Bolster dressings. Compression dressings. OpSite dressing. Conventional dressings. Quality Assessment: NR	Patients with the following wound types: DFUs. Skin grafts. Pressure ulcers. Sternal wounds. Chronic wounds and complex/severe wounds.	Outcomes included: Wound size. Rate of epithelialization. Required repeat split-thickness grafts. Time to reach surgical readiness. Median hospital stay. Treatment duration.	Some studies demonstrated a benefit to treatment by NPWT, although a majority of studies were probably too small to detect significant differences. Both foot ulcers and chronic and complex wounds treated with NPWT demonstrated significantly greater reduction in wound volume, depth and treatment duration compared to those managed with saline-moistened gauze and wet-to-moist treatment, respectively. NPWT appears to be more effective than absorbent film-backed dressing and bolster dressings in skin-graft management. Authors conclude that NPWT appears to be a promising alternative for the management of various wounds.
Gray & Peirce 2004 (177) Is Negative Pressure Wound Therapy Effective for the Management of Chronic Wounds?	To respond to the following questions: Does NPWT improve healing of chronic wounds when compared to topical treatments? Does NPWT improve skin graft survival when compared to other topical treatments? What adverse side effects have been associated with the use of NPWT?	Searches were undertaken of the MEDLINE and CINAHL databases from January 1966 to January 2004; and OVID databases search service including ACP Journal Club, Cochrane Database of Systematic Review, Cochrane Central Register of Controlled Trials and Database of Abstracts of Reviews of Effects.	Articles reporting original research, English-language abstracts and review articles or chapters from key references in the wound, ostomy, and continence (WOC) nursing literature were included. Research used to judge efficacy was limited to systematic literature reviews, results of experimental (RCTs), and quasi-experimental studies. Results from individual case studies and clinical series (summaries of experience based on multiple case studies) were included to address Question 3 (safety).	Studies: 2 systematic reviews including 2 RCTs 3 non-randomized comparison 1 interim analysis and 3 quasi-experimental Comparators: Saline (gauze or Ringer's) (k = 3). Healthpoint System (k = 1). Conventional (k = 1). Gel and gauze (k = 1). Silver sulfadine or mafenide acetate and gauze (k = 1). OpSite dressing (k = 1). Bolster dressing (k = 1). N = 279 Quality Assessment: NR	Patients with the following wound types: Pressure. Wound dehiscence. Venous insufficiency. Radiation. Trauma. Diabetic foot wounds. Sternal. Burn.	Outcomes included: Healing time Change in wound dimensions Duration of treatment Time to suture removal	Key questions addressing the benefit of NPWT compared to other topical treatments and the adverse side effects associated with the treatment were included in this review. The authors concluded that NPWT may be superior to saline-moistened gauze in the treatment of chronic wounds. In addition, superiority of NPWT was determined in the treatment of soft-tissue flaps and skin grafts when compared to topical antimicrobial agents and gauze. Authors were unable to determine whether NPWT is superior to advanced dressings in the treatment of pressure ulcers and diabetic foot ulcers. The study also confirms previous reports that adverse events with NPWT are uncommon.
Samson et al. 2004 (182) Wound-Healing Technologies: Low-Level Laser and Vacuum-Assisted Closure Prepared for the Agency for Healthcare Research and Quality	To systematically review evidence on low-level laser and V.A.C.® on wound healing outcomes	Searches were completed of MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. Kinetic Concepts Inc., manufacturer of V.A.C.® was invited to submit clinical data.	Only RCTs of vacuum-assisted closure compared to other wound healing interventions or with sham intervention. Trials must report on one of the outcomes of interest.	Studies: 6 RCTs Comparators: Standard of care dressings (k = 5). Healthpoint System (k = 1). N = 148 Quality Assessment: U.S. Preventive Services Task Force	Patients with mean ages ranging from 41.7 to 56 with the following wound types: Full-thickness wounds. Pressure ulcers. Non-healing wounds. DFUs.	Primary outcomes included: Incidence of complete wound closure. Time to complete closure. Adverse events. Secondary outcomes included: Need for debridement. Infections. Pain. Quality of life.	Only 6 RCTs qualified for inclusion in this review; five studies included fewer than 25 patients. All studies were of poor quality with only one study having a clearly stated randomization method. Study authors concluded that V.A.C.® trials did not find a significant advantage for intervention on primary endpoint, complete healing and did not consistently find significant differences on secondary endpoints.

DFU = Diabetic foot ulcer
HTA = Health technology assessment
NR = Not reported
SR = Systematic review
* Reports contain duplicate studies however one report focuses on chronic wounds (174) and excludes 5 studies.

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Table 39b. Characteristics of Systematic Reviews of NPWT Devices—Low Quality Reviews

Citation	Objective	Search Strategy	Key Inclusion/ Exclusion Criteria	Evidence Base/ Method of Assessing Study Quality	Participant Characteristics	Outcomes Assessed	Results and/or Authors' Conclusions
Contractor et al. 2008 (185) Negative Pressure Wound Therapy With Reticulated Open Cell Foam in Children: An Overview	To discuss the versatility of NPWT/ROCF in exclusively pediatric patients with infected wounds	NR	Articles discussing NPWT with reticulated open cell foam (NPWT/ROCF) exclusively in pediatric patients were included.	Studies: 9 retrospective reviews. 11 case studies. Comparators: N/A Quality Assessment: NR	Children ranging in age from neonates to young adults with the following wound types: Open fracture. Traumatic soft tissue. Chronic extremity wound. Pressure ulcer. Pilonidal disease. Sternal. Spine fusion. Fistula. Burns.	Outcomes included: Frequency of change. Pain. Complications. Time for wound closure. Recurrence. Infection.	This review focused on the unique challenges facing the use of NPWT in pediatric patients with infected wounds. The evaluation of single case studies revealed V.A.C.® as a safe alternative to traditional methods in treating axial, chronic extremity wounds and complex lawnmower injuries. Additional benefits included a reduction in infection rates in tibial shaft fractures and spinal fusions. RCTs are necessary to determine consensus on foam (white or black) selection, optimum amount of negative pressure, frequency of NPWT/ROCF dressing changes, and interposing contact layer selection.
Schintler and Prandl 2008 (170) Vacuum-assisted closure—what is evidence based?	NR	Articles were identified by search of PubMed and Medline	Included experimental animal studies, RCTs, observations of clinical applications and case reports	Studies: 7 RCTs. 3 SRs. 2 retrospective reviews. 1 cost-effective analysis. 1 consensus study. Comparators: Standard of care Saline gauze Gel products N = 445 (RCTs) Quality Assessment: NR	Patients with the following wound types: Chronic leg ulcers. Acute and chronic. Post-amputation stumps. Chronic non-healing. DFU	Wound dimensions. Time to surgery. Rate of granulation tissue formation. # of wounds healed. Need for further surgery.	A majority of this review focused on the mechanisms of action of vacuum therapy (VT). The investigators concluded that VT, when used by experienced surgeons, is an excellent option to support wound healing.
Raja and Berg 2007 (186) Should vacuum-assisted closure therapy be routinely used for management of deep sternal wound infection after cardiac surgery?	To address the question whether V.A.C.® should be routinely used for management of deep sternal wound infection after cardiac surgery	Medline 1996 to November 2006 using OVID interface, EMBASE 1980 to 2006 Week 52	NR	Studies: 7 retrospective analysis. 2 reviews. 4 case series. Comparators: Standard of care V.A.C.® plus myocutaneous flap or primary wound closure Quality Assessment: NR	Patients with deep sternal wounds	Outcomes included: In-hospital stay. Rewiring. Survival.	Current evidence is weak to support the routine use of V.A.C.® for management of deep sternal wound infection after cardiac surgery.
Mendonca et al. 2006 (187) Negative-pressure wound therapy: a snapshot of the evidence	To provide an overview of clinical studies using NPWT and propose avenues for further research to elucidate the exact mechanism of NPWT	Medline, PubMed and Cochrane databases were searched from 1995-2006.	NR	Studies: 1 SR. 5 RCTs. 10 case series. 5 basic science. Comparators: Saline gauze Standard of care Quality Assessment: NR	Patients with the following wound types: Acute and chronic. Traumatic wounds. Sternal, spinal and lower limb. High-energy. Pressure ulcers. DFUs. Infected wounds.	Outcomes included: Rate of wound healing. Wound volume. Need for further surgery. Readmission rate. Complication rate.	Key points stated by the authors include benefits and complications to treatment by NPWT, role for future research, cost savings and clinical effectiveness. Due to the mixed results in the few RCTs examined, authors cannot confirm a clear clinical effectiveness of TNP. The benefits to treatment, however, include a decrease in time to healing and limb salvage for DFUs an aid in the healing of skin grafts and a valuable adjunct to conventional treatment of sternal wound infection.
Gupta & Cho 2004 (188) A Literature Review of Negative Pressure Wound Therapy	To assess existing published data supporting the use of NPWT in multiple clinical situations	A search of the Medline database and a hand search of bibliographies were conducted. Authors also asked clinicians who may be considered experts in wound reconstruction and wound care to submit references.	Retrospective case studies, individual case reports, published letters/comments, animal studies and prospective trial were included.	NR Quality Assessment: rating system developed by study authors	Patients with the following wound types: Sternal wounds. Skin grafts. Pressure sores. Abdominal wall/laparotomy. Enterocutaneous fistulae. Diabetic wounds. Lower extremity wounds/trauma.	NR	Authors conclude that the clinical outcomes demonstrate significance in all of the comparative studies with overall outcome data supporting its effectiveness.
Fisher and Brady 2003 (168) Vacuum assisted wound closure therapy The Canadian Coordinating Office for Health Technology Assessment (CCOHTA)	NR	NR	NR	Studies: 4 randomized controlled trials (RCTs) 1 interim analysis Comparators: Saline gauze (k = 2). OpSite (k = 1). Conventional treatment (k = 1). Healthpoint System (k = 1). N = 145 Quality Assessment: NR	Patients with the following wound types: Post-operative diabetic foot. Requiring skin grafts. Elective surgery patients—postoperative ventral hernia repair. Pressure ulcers (interim analysis).	Included: Changes in wound volume/depth. Duration of treatment. Length of hospital stay. Time to suture removal.	Outcomes from four small RCTs and 1 interim analysis treated with vacuum assisted closure (V.A.C.®) therapy include a statistically significant positive impact on healing rate, faster healing and a greater reduction in wound surface area. Due to study flaws including short-term follow-up, questionable methods of randomization and allocation concealment, the authors conclude that the studies provide only poor quality data and weak evidence that V.A.C.® therapy may be superior to conventional methods used in healing wounds.
Higgins 2003 (169) The effectiveness of vacuum assisted closure (V.A.C.®) in wound healing Clayton, Australia, Centre for Clinical Effectiveness (CCE)	To assess the effectiveness of V.A.C.® in terms of healing time and wound closure compared to passive wound therapy	The Cochrane Library Ovid Biological Abstracts, Medline, EBM Reviews, CINAHL, and PreMEDLINE Australasian Medical Index National Guidance Clearinghouse Scottish Intercollegiate Guideline Network and website “www.vacuumtherapy.co.uk/index.htm” were all searched through August 2003.	Studies comparing vacuum assisted closure with any other form of dressing in patients with acute and chronic wounds were included. Level III and IV Evidence, studies published in non-English language, presenting data published in another report and narrative reviews were excluded.	Studies: 1 Systematic review including 2 RCTs 1 RCT 1 interim analysis Comparators: Saline gauze (k = 2). Wet-to-dry/wet-to-wet dressings (gauze soaked with Ringers solution) (k =1). Healthpoint System (k = 1). N = 78 Quality Assessment: based on NHMRC guidelines (2000)	Patients with the following wound types: Pressure sores (paraplegic or tetraplegic patients). Chronic wounds. Diabetic foot ulcers. Ischial, sacral, malleolar, trochanteric and calcaneal.	Outcomes included: Time for wound size to reduce to 50% of the initial volume. Time to complete healing. Rate of change in wound area. Wound volume. Proportion of wounds completely healed within trial period.	In this update to the Evans and Land (2003) systematic review, investigators confirm previous findings that V.A.C.®, when compared to other wound therapies, may provide an additional treatment benefit to patients. The methodological limitations and small study size of the four included studies, however, limits the validity of any study conclusions.

DFU = Diabetic foot ulcer
NR = Not reported
SR = Systematic review

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Table 40. Study Inclusion in Systematic Reviews

Part I (Contractor-OHTAC) (select for Part II)

Reference	Contractor 2008 (185)***	Costa 2005 (181)	Fisher 2003 (CCOHTA) (168)	Gray 2004 (177)	Gregor 2008 (173)	Gupta 2004 (188)*	Higgins 2003 (169)	Kanakaris 2007 (25)**	Mendonca 2006 (187)**	Noble-Bell and Forbes (70)	OHTAC 2006 (184)
Argenta 1997									X
Armstrong 2005					X					X	X
ASERNIP 2003
Augustin 2007
Avalia-T 2005
Berg 2000
Braakenburg 2006
Catarino 2000		X
Costa 2005
Cowan 2005
Davydov 1994			X	X
Domkowski 2003
Doss 2002		X			X
Eginton 2003		X		X	X					X
Etoz 2004					X					X
Evans 2006
Evans 2001		X
Fleck 2002
Ford 2002		X	X	X	X		X				X
Fuchs 2005
Genecov 1998		X	X	X	X
Greer 1999
Gupta 2004
Gustafsson 2002
Heath 2002
Higgins 2003 (CCE)
IQWiG 2006
Jeschke 2004
Joseph 2000		X	X	X			X		X		X
Kamotz 2004					X
Llanos 2006
Loree 2004									X
Luckraz 2003
MAAS 2006
McCallon 2000			X	X	X		X			X
McGill 2005
Mendonca 2006
Moisidis 2004		X			X						X
Molnar 2004
Morris 2007
Moues 2004		X			X				X		X
OHTAC 2006
Page 2003		X			X				X
Pham 2006
Samson 2004
Scherer 2004		X		X	X
Schrank 2004					X
Schwien 2005
Segers 2005
Shilt 2004		X						X
Sjogren 2005
Sjogren 2005
Song 2003		X		X
Stannard 2006								X
Stone 2004					X
Vuerstaek 2006
Wanner 2003		X		X	X		X				X
Weed 2004									X
Wild 2004					X
Willy 2006
Yang 2006								X
Total Studies	*******	14	5	9	16	NR	4	3**	6	4	6

Part II (Pham-Wasiak)

Reference	Pham 2006 (176) **	Raga and Berg 2007 (186) **	Samson 2004 (182)	Schimmer 2008 (175)	Schintler and Prandl 2008 (170)	Ubbink 2008 (174)	Ubbink 2008 (183)	van den Boogaard 2008 (107)	Vikatmaa 2008 (178)	Vlayen et al. 2007 (180)	Wasiak 2007 (172)
Argenta 1997					X
Armstrong 2005					X		X		X	X
ASERNIP 2003										X
Augustin 2007					X
Avalia-T 2005										X
Berg 2000				X
Braakenburg 2006					X		X	X	X	X
Catarino 2000	X			X
Costa 2005
Cowan 2005				X
Davydov 1994	X
Domkowski 2003				X
Doss 2002	X
Eginton 2003	X		X		X	X	X		X	X
Etoz 2004							X		X	X
Evans 2006
Evans 2001
Fleck 2002				X
Ford 2002	X		X		X	X	X	X	X	X
Fuchs 2005				X
Genecov 1998	X									X
Greer 1999	X
Gupta 2004
Gustafsson 2002				X
Heath 2002	X
Higgins 2003 (CCE)										X
IQWiG 2006
Jeschke 2004	X						X			X
Joseph 2000	X		X		X	X	X	X	X	X
Kamotz 2004
Llanos 2006							X		X	X
Loree 2004
Luckraz 2003				X
MAAS 2006										X
McCallon 2000	X		X		X	X	X		X	X
McGill 2005										X
Mendonca 2006					X					X
Moisidis 2004	X						X		X	X
Molnar 2004											X
Morris 2007					X
Moues 2004	X		X		X	X	X	X	X	X
OHTAC 2006
Page 2003										X
Pham 2006
Samson 2004					X
Scherer 2004	X									X
Schrank 2004										X
Schwien 2005
Segers 2005				X
Shilt 2004
Sjogren 2005				X
Sjogren 2005
Song 2003	X
Stannard 2006									X	X
Stone 2004
Vuerstaek 2006					X	X	X		X	X
Wanner 2003	X		X		X	X	X	X	X	X
Weed 2004
Wild 2004
Willy 2006										X
Yang 2006
Total Studies	16	NI	6	10	14	7	13	5	13	25	1

NI = Not included
NR = Not reported

* Did not reference study by name.
** Case series or chart reviews not included in listing.
*** Based on 9 retrospective reviews and 11 case studies not listed.

We assessed the quality of each review using the ‘assessment of multiple systematic reviews' (AMSTAR) measurement tool.(171) The AMSTAR consists of 11 items, which have been tested for face and content validity. The items assess whether or not a systematic review includes important elements, such as a comprehensive literature search, assessment of study quality, appropriate methods to combine study findings, and assessment of publication bias. Responses to each item are checked as ‘Yes' if the review includes that item, ‘No' if it does not, ‘CA' if the item cannot be answered by the information provided in the review, or ‘NA' if the item is not applicable. The AMSTAR does not provide a method for rating the quality of a review. To rate the quality of the reviews, we applied the following criteria: a rating of ‘High' if the review received mostly ‘yes' responses (at least 8), a rating of ‘Low' if the review received mostly ‘no' responses (at least 8), and a rating of ‘Moderate' if the review received mixed responses.

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Table 41. Quality of Systematic Reviews

Reference	Was an ‘a priori' design provided?	Was there duplicate study selection and abstraction?	Was a comprehensive literature search performed?	Was the status of publication (i.e., English only) used as inclusion criterion?	Was a list of studies (included and excluded) provided?	Were the characteristics of the included studies assessed and documented?	Was the scientific quality of the included studies assessed and documented?	Was the scientific quality of the included studies used appropriately in formulating the conclusions?	Were methods used to combine the findings of studies appropriate?	Was the likelihood of publication bias assessed?	Was any conflict of interest stated?	Overall Rating
Contractor et al. 2008 (185)	N	N	N	N	N	N	N	N	NA	N	N	Low
Gregor et al. 2008 (173)	CA	Y	Y	Y	N	N	Y	Y	Y	Y	Y	High
Noble-Bell and Forbes 2008 (70)	CA	Y	Y	Y	Y	N	N	Y	NA	N	N	Moderate
Schimmer et al. 2008 (175)	CA	N	N	Y	N	N	N	Y	NA	N	N	Moderate
Schintler and Prandl 2008 (170) )	CA	N	Y	N	N	N	N	N	NA	N	N	Low
Ubbink et al. 2008 (174)	Y	Y	Y	Y	Y	Y	Y	Y	NA	Y	Y	High
Ubbink et al. 2008 (183)	CA	Y	Y	Y	N	N	Y	Y	NA	N	N	Moderate
van den Boogaard et al. 2008 (107)	Y	Y	Y	Y	N	N	Y	Y	NA	N	N	Moderate
Vikatmaa et al. 2008 (178)	CA	Y	Y	Y	N	N	Y	Y	N	N	Y	Moderate
Kanakaris et al. 2007 (25)	CA	N	Y	Y	N	N	N	Y	NA	N	Y	Moderate
Raja and Berg 2007 (186)	Y	N	Y	N	N	N	N	N	NA	N	N	Low
Vlayen et al. 2007 (180)	CA	Y	Y	Y	Y	Y	Y	Y	NA	N	N	Moderate
Wasiak and Cleland 2007 (172)	Y	Y	Y	Y	Y	Y	Y	Y	NA	Y	Y	High
Mendonca et al. 2006 (187)	CA	N	Y	N	N	N	N	N	NA	N	N	Low
Ontario Health Technology Advisory Committee (OHTAC) 2006 (184)	N	N	Y	Y	Y	Y	Y	Y	NA	N	N	Moderate
Pham et al. 2006 (176)	Y	Y	Y	Y	N	N	Y	Y	NA	N	N	Moderate
Costa et al. 2005 (181)	CA	N	Y	Y	N	N	N	NA	NA	N	N	Moderate
Gray & Peirce 2004 (177)	CA	N	Y	Y	N	N	Y	Y	NA	N	N	Moderate
Gupta & Cho 2004 (188)	N	N	N	Y	N	N	N	N	NA	N	N	Low
Samson et al. 2004 (182)	CA	Y	Y	Y	Y	Y	Y	Y	NA	N	N	Moderate

Source: Shea et al. 2007, AMSTAR: a measurement tool to assess the quality of systematic reviews.(171)
ECRI Institute applied overall assessment ratings using the following criteria: “High” if a study had mostly yes's (at least 8), “Moderate” if a mix of yes, no's, and can't answer, and “Low” if a study had mostly no's (at least 8)

CA = Can't answer
NA = Not applicable

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Table 42. Adverse Events Described in Systematic Reviews

Reference	Included Study	Wound Type	Treatment(s)	Complication	Comorbidities
Contractor et al. 2008 (185)	Trop 2006	Burn	NPWT	Massive hematoma in 2 burn patients in the absence of anticoagulation therapy in both a graft and a graft-donor site	NR
	Baharestani 2007	Open fracture, abdominal compartment syndrome, sacral, sternal, degloving injury	NPWT	Enterocutaneous fistula developing in a patient's exposed bowel	NR
	McCord 2007	Pressure ulcers, extremity, dehisced surgical, sternal, fistulas, abdominal defects	NPWT	6 wounds failed to heal	Included infection, an enterocutaneous fistula, and/or immunosuppression
Gregor et al. 2008 (173)	Armstrong 2005	DFU	NPWT	Infections—more common in NWPT	NR
Gregor et al. 2008 (173)	Armstrong 2005	DFU	Standard of care		NR
Noble-Bell and Forbes 2008 (70)	McCallon 2000	DFU	NPWT	Bleeding and pain at time of dressing change	NR
	Etoz 2004		NPWT	Bleeding and pain at time of dressing change
	Eginton 2003		NPWT	Withdrawal due to incorrect pressure setting (too low)
Schimmer et al. 2008 (175)	Segers 2005	Post-sternotomy mediastinitis	V.A.C.®		NR
Schimmer et al. 2008 (175)	Segers 2005	Post-sternotomy mediastinitis	Primary closure with suction/ irrigation system	Higher rates of recurring infection, therapeutic failure at discharge	NR
Ubbink et al. 2008 (174)	Joseph 2000	Chronic	TNP vs. gauze	3 complications in the NPWT group (n=18) and 8 (n=18) in the gauze group (RR: 2.67; 95% CI: 0.84 to 8.46). Difference not statistically significant	NR
Ubbink et al. 2008 (174)	Vuerstaek 2006	Chronic ulcers	TNP vs. choice of hydrocolloid or alginate dressing	No significant difference in the complication rate between groups (40% in the NPWT group compared with 23% in the wound gel group; (RD:0.17; 95%CI: -0.06 to 0.40) No significant difference in mean score for present pain intensity (PPI) in the eighth week of treatment (0.2 (SD 0.7) for NPWT and 0.4 (SD:0.6) for the control group; (WMD:-0.20; 95% CI: -0.53 to 0.13)	NR
Raja and Berg 2007 (186)	Gustafsson 2003	Sternal	V.A.C.®	Subcutaneous fistulas—3	NR
	Domkowski 2003	Sternal	V.A.C.®	Hospital mortality—4 (3.7%) for all patients	NR
	Domkowski 2003	Sternal	Standard of care	Hospital mortality—4 (3.7%) for all patients	NR
	Luckraz 2003	Sternal	V.A.C.®	Mortality—4	NR
	Luckraz 2003	Sternal	V.A.C.® followed by a myocutaneous flap or primary wound closure	Mortality—7.7% Treatment failure rate—15%	NR
	Doss 2002	Sternal	V.A.C.®	Mortality—1	NR
	Doss 2002	Sternal	Standard of care	Mortality—1	NR
Vlayen et al. 2007 (180)	Armstrong 2005	DFU	NPWT	Infection—17% Treatment related adverse events—12%	NR
	Armstrong 2005	DFU	Standard of care	Infection—6% Treatment related adverse events—13%	NR
	Joseph 2000	Chronic non-healing	NPWT	Infection—0%	NR
	Joseph 2000	Chronic non-healing	Gauze	Infection—33%	NR
	Vuerstaek 2006	Leg ulcers	NPWT	Infection—0% Cutaneous damage secondary to therapy—23%	NR
	Vuerstaek 2006	Leg ulcers	Standard of care	Infection—3% Cutaneous damage secondary to therapy—7%	NR
	Braakenburg 2006	Chronic and acute	NPWT	Discontinuation of treatment—2 patients due to pain during dressing changes or during NPWT	NR
	Braakenburg 2006	Chronic and acute	Various dressings		NR
Mendonca et al. 2006 (187)	DeFranzo 2001	Lower extremity	NPWT	3 cases of osteomyelitis	NR
OHTAC 2006 (184)	Armstrong 2005	DFU	NPWT	Infection—13 (17%) 4 severe	NR
OHTAC 2006 (184)	Armstrong 2005	DFU	Standard of care	Infection—5 (6%) 2 were severe	NR
Costa et al. 2005 (181)	Song 2003	Sternal	NPWT	Osteomyelitis—1 (6%) Calcaneal fractures—2 (11%)	NR
	Song 2003	Sternal	Standard of care	Osteomyelitis—2 (11%) Fistulas—2 (11%) Wound infection—6 (33%)	NR
	Genecov 1998	Skin grafts	NPWT	Chronically draining wound—1 (7%) Mediastinitis—1 (7%) Omental flap losses—0 Intestinal evisceration—0 Hernia - 0	NR
	Genecov 1998	Skin grafts	OpSite	Chronically draining wound—1 (6%) Mediastinitis—1 (6%) Omental flap losses—2 (12%) Intestinal evisceration—1 (6%) Hernia—1 (6%)	NR
	Argenta 1997	Mixed	V.A.C.®	Pain—traumatic wounds required narcotics due to pain level Bleeding—excessive ingrowth of granulation tissue particularly if dressing kept >48 hours Erosion of adjacent tissue—when positioned over bone or if patient lies on the tube Fistulas—1 case Wound infection—2 (5.4%)—due to overgrowth of granulation tissue	NR
Gray & Peirce 2004 (177)	Evans 2004 (SR)	NR	NPWT	Calcaneal bone fractures—2 Osteomyelitis—1	NR
	Evans 2004 (SR)	NR	Topical treatment
	Fisher et Brady 2003 (SR)	NR	NPWT	Pain—induced from application of pressure or the intermittent pressure associated with sponge changes
	Argenta 1997	NR	NPWT	Tissue erosion—around the egress tube when placed too close to a bony prominence or when excessive pressure is placed over the sponge dressing	NR
	Gwan-Nulla and Casal 2001*	NR	NPWT	Toxic shock syndrome—1	NR
	Chester and Waters 2002*	NR	NPWT	Bacteremia and sepsis—1	NR
	Chester and Waters 2002*	NR	Standard of care	NR	NR
Samson et al. 2004 (182)	Ford 2002	Decubitus ulcers	V.A.C.® vs. Healthpoint System	2 deaths (group assignment NR) 1 patient required distal lower-extremity amputation	NR Diabetes, hypertension, vascular insufficiency and sepsis
	Joseph 2000	Chronic non-healing	V.A.C.®	3 of 18 V.A.C.® wounds developed complications including fistulas, wound infection, osteomyelitis, and calcaneal fractures	NR
	Joseph 2000	Chronic non-healing	Standard are	8 of 18 wounds developed complications including fistulas, wound infection, osteomyelitis, and calcaneal fractures	NR

SR = Systematic review
* Case study

The Medical Advisory Secretariat performed a post hoc calculation to determine if the difference in the rate of wound infections was statistically significant between groups, and calculated a statistically significant higher rate of wound infection in the NPWT group compared to control (P = 0.04), based on a 2-tailed Fisher's exact test. MAS did not take into account the severity of the wounds.

Current as of November 2009

Internet Citation: Appendix C: Technology Assessment Report, Negative Pressure Wound Therapy Devices. November 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/findings/ta/negative-pressure-wound-therapy/appendix-c.html