Appendix C

Technology Assessment Report, Negative Pressure Wound Therapy Devices

Technology assessment on negative pressure wound therapy devices.

Appendix C: Evidence Tables

Table 16. Comparison Trials of NPWT Devices Used to Treat Chronic Wounds
Table 17. Comparison Trials of NPWT Used to Treat Acute Wounds
Table 18. Comparison Trials of NPWT Devices Used to Secure Skin Graft
Table 19. Key Study Design Characteristics of Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic Wounds
Table 20. Patient Characteristics in Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic Wounds
Table 21. Treatment-Related Characteristics in Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic Wounds
Table 22. Results for Outcome Measures Reported in Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic Wounds
Table 23. Study Design Characteristics of Comparison Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure Ulcers
Table 24. Patient Characteristics in Comparison Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure Ulcers
Table 25. Treatment-Related Characteristics in Comparison Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure Ulcers
Table 26. Results for Outcome Measures Reported in Comparison Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure Ulcers
Table 27. Key Study Design Characteristics of Comparison Studies of NPWT Devices* Used to Secure Skin Graft
Table 28. Patient Characteristics in Comparison Studies of NPWT Devices* Used to Secure Skin Graft
Table 29. Treatment-Related Characteristics in Comparison Studies of NPWT Devices* Used to Secure Skin Graft
Table 30. Results for Outcome Measures Reported in Comparison Studies of NPWT Devices* Used to Secure Skin Graft
Table 31. Key Study Design Characteristics of Comparison Studies of NPWT Devices* Used to Treat Acute Wounds
Table 32. Patient Characteristics in Comparison Studies of NPWT Devices* Used to Treat Acute Wounds
Table 33. Treatment-Related Characteristics in Comparison Studies of NPWT Devices* Used to Treat Acute Wounds
Table 34. Results for Outcome Measures Reported in Comparison Studies of NPWT Devices* Used to Treat Acute Wounds
Table 35. Characteristics of Patients with Acute Wounds
Table 35a. Characteristics of Patients with Chronic Wounds (continued)
Table 35b. Characteristics of Patients with Mixed Wound Types (continued)
Table 36. Treatment Details for All Wound Types
Table 37. Outcomes Reported for All Wound Types
Table 38. Adverse Events Reported for All Wound Types
Table 39. Characteristics of Systematic Reviews of NPWT Devices—High Quality Reviews
Table 39a. Characteristics of Systematic Reviews of NPWT Devices—Moderate Quality Reviews
Table 39b. Characteristics of Systematic Reviews of NPWT Devices—Low Quality Reviews
Table 40. Study Inclusion in Systematic Reviews
Table 41. Quality of Systematic Reviews
Table 42. Adverse Events Described in Systematic Reviews

Key Question 1

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

ReferenceWound TypeComparatorNumber of Patients EnrolledQuality Score*
Blume et al. 2008 (108)Diabetic Foot UlcerAdvanced Moist Wound Therapy (AMWT)342Moderate
Armstrong et al. 2007 (109)Diabetic Foot UlcerStandard wound therapy (SWT)162Moderate
Lavery et al. 2007 (341)Diabetic Foot UlcerWet-to-moist1,721Low
McCallon et al. 2000 (120)Diabetic Foot UlcerSaline-moistened gauze10Low
Schwien et al. 2005 (126)Pressure UlcerAny other wound care modality2,348Low
Wanner et al. 2003 (118)Pressure UlcerGauze soaked with Ringer's solution22Low
Ford et al. 2002 (110)Pressure UlcerHealthpoint System (HP)28Moderate
Joseph et al. 2000 (113)Pressure UlcerSaline wet-to-moist24Moderate
Denzinger et al. 2007 (135)Complex InguinalSaline moistened gauze16Low
Moues et al. 2007 (136)Full-thicknessStandard moistened gauze54Low
Siegel et al. 2007(119)Radiation-associatedStandard of care41Low
Braakenburg et al. 2006 (114)Chronic and acuteHydrocolloid dressings, alginates, acetic acid or Eusol (sodium hypochlorite)65Moderate
Bickels et al. 2005 (134)Soft tissue defectsStandard of care38Low
Page et al. 2004 (1)Open footStandard of care47Low

* 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

ReferenceWound TypeComparatorNumber of Patients EnrolledQuality Score*
Timmers et al. 2009 (106)Post-traumatic osteomyelitisSOC124Low
Simek et al. 2008 (123)Deep sternalConventional62Low
Yang et al. 2006 (72)FasciotomySOC68Low
Stannard et al. 2006 (125)Study 1: hematomaStudy 1: Pressure dressingStudy 1: 44Low
Study 2: fractureStudy 2: Post-operative dressingStudy 2: 44Low
Fuchs et al. 2005 (23)Deep sternalConventional68Low
Immer et al. 2005 (130)Deep sternal wound infectionSternal excision and primary musculocutaneous flap55Low
Segers et al. 2005 (122)Post-sternotomy mediastinitis (PM)Closed drainage63Low
Sjogren et al. 2005 (139)PMConventional101Low
Domkowski et al. 2003 (129)PMSOC102Low
Song et al. 2003 (124)SurgicalStandard of care (SOC)35Low
Doss et al. 2002 (128)Post-sternotomy osteomyelitisSOC42Low
Catarino et al. 2000 (137)PMClosed drainage and irrigation17Low
Shilt et al. 2004 (138)TraumaticSOC31Low
Kamolz et al. 2003 (343)BurnSilver sulphadiazine7Low
Gabriel et al. 2008 (339)InfectedSOC30Low
Ozturk et al. 2008 (117)Fournier's gangreneSOC10Low
Rinker et al. 2008 (121)Open tibia fractureSOC55Low
Huang et al. 2006 (127)LimbSOC24Low
Labler et al. 2004 (71)Soft tissueEpigard® dressing23Low

* 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

ReferenceWound TypeComparatorNumber of Patients EnrolledQuality Score*
Korber et al. 2008 (340)Chronic legStandard of care (SOC)54Low
Vuerstaek et al. 2006 (111)Chronic legConventional (hydrocolloids, alginates)60Moderate
Vidrine et al. 2005 (342)Skin grafted radial forearmBolster dressing plus splint44Low
Moisidis et al. 2004 (112)Clinically ready for skin graftBolster dressing22Moderate
Stone et al. 2004 (133)STSGCotton bolster dressing40Low
Scherer et al. 2002 (132)STSGCotton bolster dressing61Low
Genecov et al. 1998 (131)STSGOpsite10Low

* 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

ReferenceStudy TypeWound TypeNumber of Patients EnrolledComparison TreatmentInclusion CriteriaExclusion CriteriaLength of StudyAttrition
Moues et al. 2007 (136)RCT*Full-thickness54Standard moist gauzeFrom 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 characterMalignant disease, superficial bare blood vessels, deep fistulas, necrotic tissue, an unstable skin around the wound, sepsis, untreated Osteomyelitis, active bleeding, uncontrolled diabetes and psychiatric disordersReady for surgical readinessV.A.C.®—3
Control—2
Braakenburg et al. 2006 (114)RCT*Acute and chronic65

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 intentionNR
Denzinger et al. 2007 (135)Non-RCT*Inguinal wounds16Saline-moistened gauzePatients with inguinal regions subjected to lymphadenectomy for penile cancer between 2000 and 2006.NRComplete wound closureNR
Siegel et al. 2007 (119)Non-RCT*Radiation-associated41SOCNPWT:
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

NRUntil wound healing by either primary or secondary intention, skin grafting or soft tissue transpositionNR
Bickels et al. 2005 (134)Non-RCT*Soft tissue defects62SOCV.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 foot47Saline-soaked gauzePatients 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 interventionPersistent wound infection, necrotic tissue in the wound bed, and interruption in treatment or use of alternative therapies during the wound cavity filling timeNRNR

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

ReferenceStudy TypeNumber of PatientsMean (SD) Age (years)SexComorbiditiesNumber of WoundsMean (SD) Baseline Wound Area (cm2) or Volume (cm3)Severity of WoundsMean (SD) Duration of Ulcer
Moues et al.(136)RCTV.A.C.®: 2947.7 ±19.6NRDiabetes—6
Vascular compromised—8
Osteomyelitis—8
29NR12 early treated,
17 late treated
NR
RCTStandard moist: 2547.9 ±17.0NR
Diabetes—1
Vascular—3
Osteomyelitis—4
Spinal cord lesion—5
25 8 early treated,
17 late treated
 
Braakenburg et al.(114)RCTV.A.C.®: 3265.5 medianM20
F12
Diabetes—12 (37%)
Vascular surgery—9 (28%)
Cardiovascular disease—11 (34%)
Smoking—8 (29%)
3229.5 cm2 (median)
Range: 3 to 600 cm2
Chronic—64%
Acute—11%
Subacute—23
NR
RCTControl: 3369.2 medianM16
F17
NR3330 cm2 (median)
Range: 6 to 152 cm2
NRNR
Denzinger et al.(135)Non-RCTV.A.C.®: 564M5No difference reported634 cc
Range: 24-54
NRNR
Non-RCTSOC: 967M91037 cc
Range: 24-84
Siegel et al.(119)Non-RCTV.A.C.®: 2241 (24-78)NRNR22111 cm3
Range: 2.5-3,660
NRNR
Non-RCTSOC: 1946 (19-67)NR19410 cm3
Range: 4-3,800 cm3
NRNR
Bickels et al.(134)Non-RCTV.A.C.®: 23Median: 46.5
Range: 36-72
M8
F15
NR23Mean: 345 cm2
Range: 64 cm2 to 520 cm2
NRNR
Non-RCTSOC: 39 M21
F18
NRNRNRNRNR
Page et al.(1)Non-RCTV.A.C.®: 2266 (±12)M22Diabetes—17 (77%)22Wound dimensions were not consistently recorded

Wounds were divided into small, medium and large
Small 2 (9%)
Med 6 (27%)
Lg 14 (64%)

NRNR
Non-RCTControl: 2560 (±11)M25Diabetes—14 (56%)25Small 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

ReferenceStudy TypeTreatmentsTreatment ChangeWound AssessmentFrequency of MeasurementsTreatment DurationPrior TreatmentsConcurrent Treatments
Moues et al. (136)RCTV.A.C.®

Continuous pressure of 125 mmHg

Polyurethane foam dressing with a pore size of 400-600 um (V.A.C.® pack)

48 hrsTrace 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 treatmentEvery 48 hrsReady for surgical readiness or 30 days or prior to 30 days if treatment terminatedNR
  • 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
RCTStandard moist- saturated in either 0.9% saline, 0.2% nitrofuralam, 1% acetic acid or 2% sodium hypochlorite2x/day minimum
Braakenburg et al.(114)RCTV.A.C.®

CNP: -125 mmHg

Black polyurethane foam dressing with a pore size of 400 to 600 um

3x/wkPhotos and bacteriologic swabs—1x/wk

Wound surface measured with a standardized drape—2x/wk

Pain assessed with visual analogue scale—3x/wk

3x/wkNRNRSurgical debridement
RCTConventional1 or more times/day
Denzinger et al.(135)Non-RCTV.A.C.®

Continuous negative pressure (125 mmHg)

Foam dressing

Every 3dNRNRComplete wound closureInguinal lymphadenectomy for penile cancer
  • Surgical debridement
  • Secondary surgical debridement
  • Adjuvant radiotherapy or chemotherapy: 2 V.A.C.® and 3 SOC
Non-RCTSOC

+ hydrogel (n = 3)

+ hydrocolloid (n = 2)

Every other day
Siegel et al.(119)Non-RCTV.A.C.®

Continuous 125 mmHg

Sponge

Every 2-3dNRNRAverage: 41d over a 3 year periodSurgical 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)
Non-RCTSOC and/or additional soft tissue coverage procedures     
Bickels et al.(134)Non-RCTV.A.C.®

Continuous negative pressure: -125 mmHg

Polyurethane foam dressing

48 hours for 7 to 19 daysNRNR

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
Non-RCTSOCDailyNRNR
  • 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-RCTV.A.C.®NRNRNRNRNRNR
Saline moistened gauzeNRNRNRNRNRNR

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

ReferenceStudy TypeTreatmentsNWounds HealedMean (SD) Change in Wound Area (cm2) or Volume (cm3)Satisfactory HealingOther Important OutcomesAdverse Events Resulting in Discontinuation of Treatment
Moues et al. (136)RCTV.A.C.®29 3.8 ±0.5%/day (n = 15; reduction observed in 100%) SubgroupTime to surgical readiness: 6.00 ±0.52 daysNR2 (sepsis with unknown origin, ischaemic pain with increased tissue necrosis)
RCTStandard moist25 1.7 ±0.6%/day (n = 13; reduction observed in 77%)7.00 ±0.81d  
Braakenburg et al. (114)RCTV.A.C.®3226Overall change: 0.1 cm2/dayMedian 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)
RCTConventional3321Overall change: 0.1 cm2/dayMedian time in days (95% CI): 20 (16-24) 
Denzinger et al. (135)Non-RCTV.A.C.®56NR38.9d (median)Hospital stay: 13.2d (8-27)NR
Non-RCTSOC91069.8d28.4 (16-39)
Siegel et al. (119)Non-RCTV.A.C.®2221-329 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
Non-RCTSOC  NR

Split thickness graft—3
Rotational flaps—7
Free vascularized flap—4
Secondary intention—5

42d 
Bickels et al. (134)Non-RCTV.A.C.®2323 (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)NRHospital stay: 4-30d (Mean: 18.5; Median: 20d)NR
Non-RCTSOC3939NR Hospital stay: 15-72d (Mean: 37d; Median: 39d) 
Page et al. (1)Non-RCTV.A.C.®22NRMedian time of wound filling: 38d (95% CI: 26 to 70)NRMedian time to closure: 110d (79,184)NR
Non-RCTSOC25 

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

ReferenceStudy TypeWound TypeNumber of Patients EnrolledComparison TreatmentInclusion CriteriaExclusion CriteriaLength of StudyAttrition
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 debridementRecognized 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 amputation162

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 days19 NPWT and 19 SWT withdrew before wound closure
Wanner et al. 2003 (118)RCT*Pressure sores of the pelvic region22Gauze soaked with Ringer's solutionConsecutive 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.NRNRNR
Ford et al. 2002 (110)RCT*Full-thickness decubitus ulcers28Healthpoint 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 mlFistulas 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 hardware6 weeks6
Joseph et al. 2000 (113)RCT*Chronic non-healing24Saline wet-to-moist (WM) dressingsPatients 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 CenterInfection (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; fistulas6 weeksNR
Lavery et al. 2007 (341)Non-RCT*Diabetic Foot Ulcer1,721Wet-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 Ulcer2,348
(60 V.A.C.)
Any other wound care modalityData 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 ulcerPatients 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/proteinemiaNRNR
McCallon et al. 2000 (120)Non-RCT*Diabetic Foot10Saline-moistened gauzePatients 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 monthPatients presenting with venous disease, patients with active infections not resolved by initial debridement; and patients with coagulopathyUntil satisfactory healingNR

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

ReferenceStudy TypeNumber of patientsMean (SD) Age (years)SexComorbiditiesNumber of WoundsMean (SD) Baseline Wound Area
(cm2) or Volume (cm3)
Severity of WoundsMean (SD) Duration of Ulcer
Blume et al. (108)RCTV.A.C.®: 17258 ±12M 141
F 28

Smoker: 34
Uses alcohol: 37
Diabetes (type1): 15
Diabetes (type2): 154

16913.5 ±18.2NR198.3 ±323.5d
RCTAdvanced Moist Wound Therapy: 16959 ±12M 122
F 44

Smoker: 32
Uses alcohol: 45
Diabetes (type1): 14
Diabetes (type2): 152

16611.0 ±12.7 206.0 ±365.9d
Armstrong et al. (109)RCT77 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

RCT85 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

Wanner et al. (118)RCT11 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
RCT11 gauze soaked with Ringer's53 (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

Ford et al. (110)RCT

N = 22
V.A.C.®—NR

41.7 averageNRNR20NRStage III or IVNR
RCTHealthpoint system—NR54.4 average  15 
Joseph et al. (113)RCT

N = 2411
V.A.C.® NR

56M 66%NR

18

Pressure—18
Dehiscence—1
Trauma—1
Venous insufficiency—2
Radiation—1

38 cm3NRNR
RCTSaline wet-to-moist: NR49M 44% 

18

Pressure—14
Dehiscence—3
Trauma—1
Venous insufficiency—0
Radiation—0

24 cm3
Lavery et al. (341)Non-RCTV.A.C: 1,13558.5 ±9.4M 64.5%NR1,13513.8 ±15.8NR26.5 ±24.7 (wks)
Non-RCTWet-to-moist: 58658M 73.2%  1.61 30 (wks)
Schwien et al. (126)Non-RCTV.A.C.®: 6065 ±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

NRNRStage III or IVNR
Non-RCTControl: 2,28871.4 ±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

NRNR
McCallon et al. (120)Non-RCTV.A.C.®: 555.4 (±12.8)NRHemoglobin, albumin, and blood glucose levels comparable at baseline5NRNon-healingNR
Non-RCTControl: 550.2 (±8.7)  5

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

ReferenceStudy TypeTreatments (include type of NPWT dressing)Treatment ChangeWound AssessmentFrequency of MeasurementsTreatment DurationPrior TreatmentsConcurrent 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 tracingsWeekly for 4 weeks then every other week until day 112 or ulcer closureComplete ulcer closure defined as skin closure (100% re epithelization) without drainage or dressing requirements OR day 112Treated 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
RCTAdvanced Moist Wound Therapy (AMWT)As specified by Wound, Ostomy and Continence Nurses Society guidelines and institutional treatment protocolsTreated for ulcer infection prior to randomization: 45
Armstrong et al. (109)RCT

V.A.C.®

Foam dressing

Every 48 hrsDigital photos and tracingDays 0, 7, 14, 28, 42, 56, 84, and 112Until wound closure (100% re-epithelialization without drainage) or until completion of 112 day period of assessmentNR
  • 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
RCTStandard Wound Therapy (SWT)According to standardized guidelines
Wanner et al. (118)RCT

V.A.C.® continuous at 125 mmHg

Polyvinyl foam and transparent polyurethane dressing

Every 2-7 daysOne 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
RCTGauze soaked with Ringer's solution3x/day until clean granulation tissue was observed. Then wound kept wet with Ringer's and dressing changed 1 3x/day
Ford et al. (110)RCTV.A.C.®Mon/Wed/FriAt 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 weeks6 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
RCTHPonce or twice/daily     
Joseph et al. (113)RCT

V.A.C.®

Pressure NR

Open-cell foam dressing

Every 48 hoursPhotography and measured by volume displacement of alginate impression molds3 and 6 weeks or until wound closureComplete wound closure not a realistic end point since wounds were of variable sizes and anatomic locationsAll 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
RCTWM—closed system including Bioclusive Transparent Dressing (Johnson and Johnson)3x/day plus saline applied 3x/day
Lavery et al. (341)Non-RCT

V.A.C.®

NR

Every 48 hrsNR12 and 20 weeksSuccessful 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.NRSurgical debridement
Non-RCTWet-to-moistWell-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. 
Schwien et al. (126)Non-RCT

V.A.C.®
NR

NRNRTracked while NPWT was applied plus 7 days following removalNRNRNR
Non-RCT

Control

NR

NR Tracked start of care through end of careNRNRNR
McCallon et al. (120)Non-RCTV.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 hoursWound 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:

  1. Delayed primary intention. Split thickness skin graft, myocutaneous flap, or suture closure
  2. Secondary intention. Granulation tissue formation and epithelialization.
NR
  • Surgical debridement
  • Strict non-weight bearing or bedrest
Non-RCTSaline-moistened gauze (wounds not allowed to desiccate)Twice a day3x/week

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

ReferenceStudy TypeTreatmentsNWounds HealedMean (SD) Change in Wound Area (cm2) or Volume (cm3)Satisfactory HealingOther Important OutcomesAdverse Events Resulting in Discontinuation of Treatment
Blume et al. (108)RCTV.A.C.®16973 (43.2%)Reported for day 28
-4.32 (significant difference; P = 0.021)
63.6 ±36.57 days (mean ±SD)NR22
RCTAdvanced Moist Wound Therapy (AMWT)16648 (28.9%)Reported for day 28
-2.53
78.1 ±39.29 days (mean ±SD) 18
Armstrong et al. (109)RCTV.A.C.®63 acute (51.6%)
14 chronic (35%)
34 acute (54%)
9 chronic (64.3%)
NRLog-rank test comparing the time-to-event profiles was significant in favor of NPWT group over SWT for acute wounds (P = 0.030)NRNR
RCTStandard Wound Therapy (SWT)59 acute (48.4%)
26 chronic (65%)
22 acute (37.3%)
11 chronic (42.3%)
   
Wanner et al. (118)RCTV.A.C.®1111Decrease over time similar in both groups. Increase in volume was often measured 7d after first measurements in both groups.27 (10) d mean (SD)NRNR
RCTGauze soaked with Ringer's solution111128 (7) d mean (SD)  
Ford et al. (110)RCTV.A.C.®202 (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

NRNRCoronary artery disease—1
Respiratory arrest secondary to Guillain-Barre—1
Treatment group not reported
RCTHealthpoint System (HP)152 (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)RCTV.A.C.®NRNRPercent 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)

NRGranulation tissue formation in 13 (64% of wounds)NR
RCTMoist wound therapy  Percent change in wound volume over time: 30%

Change in depth: 20%

 An adequate (100%) granulating bed rarely seen
Lavery et al. (341)Non-RCTV.A.C.®113539.5% (12 wk)
46.3% (20 wk)
NR` NRNRNR
Non-RCTWet-to-moist58623.9% (12 wk)
32.8% (20 wk)
Schwien et al. (126)Non-RCTV.A.C.®NR NRNRInstances 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
Non-RCTControlNR NRNRInstances 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-RCTV.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 decreaseAverage:
22.8 (±17.4) days
NRNR
Non-RCTSaline-moistened gauze5# 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 increaseAverage:
42.8 (±32.5) days
NRNR

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

ReferenceStudy TypeWound TypeNumber of Patients EnrolledComparison TreatmentInclusion CriteriaExclusion CriteriaLength of StudyAttrition
Vuerstaek et al. 2006 (115)RCTChronic leg60Conventional (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 failedUlcer chronicity <6 months duration, age >85 years old, the use of immune suppression, allergy to wound products, malignant or vasculitis origin, or ABI <0.6012 months11
Moisidis et al. 2004 (112)RCTSplit-thickness skin graft (STSG)22 (patients used as own controls)Bolster dressingAdults admitted to Liverpool Hospital from July 2001 to July 2002 with wounds 25 cm2 or larger and clinically ready for skin graftingNR2 weeks2
Korber et al. 2008 (340)Non-RCTChronic leg ulcer54SOCMesh grafts transplanted in the Department of Dermatology, Essen, Germany from April 2003 to April 2005NRNRNR
Vidrine et al. 2005 (342)Non-RCTSTSG44Bolster dressing plus splintConsecutive skin-grafted radial forearm donor sites treated between October 2003 and November 2004NR4 weeksNR
Stone et al. 2004 (133)Non-RCTSTSG40Cotton bolster dressingTrauma patients admitted between January 2001 and January 2003 to Charleston Area Medical Center, WV who received STSG2 burn patients with heavily contaminated and extremely large woundsGrafts considered completely successful or total failures 
Scherer et al. 2002 (132)Non-RCTSTSG61Cotton bolster dressingIdentified all patients on the trauma surgery service who required STSG during an 18-month periodNRNRNR
Genecov et al. 1998 (131)Non-RCTSTSG10 (patients used as own controls)OpSitePatients requiring coverage of denuded surfacesNR7 daysNR

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

ReferenceStudy TypeNumber of PatientsMean (SD) Age (years)SexComorbiditiesNumber of WoundsMean (SD) Baseline Wound Area (cm2) or Volume
(cm3)
Severity of WoundsMean (SD) Duration of Wound
Vuerstaek et al. (115)RCTV.A.C.®: 30Median: 74 Range: 53-81M7
F23
Smoking: 6 (21%)
Diabetes mellitus type II: 5 (17%)
Immobility: 12 (41%)
Hypertension: 13 (45%)
Infection signs: 8 (28%)
NRMedian: 33
Range: 2-150
Ulcer type

Venous origin: 13
Combined venous/arterial origin: 4
Arteriolosclerotic origin: 13

8 Median
(Range: 6-24)
RCTControl: 30Median: 72 Range: 45-83M7
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)RCT20Median: 64
Range: 27-88
M12
F8
NR20128 cm2
Range: 35 to 450 cm2
Acute: 10
Subacute or chronic (>5d): 10
18d
(Range: 0 to 90d)
Korber et al. (340)Non-RCTTotal: 54
V.A.C.®: NR
66.1M23 F31Diabetes: 1528ComparableNRNR
Non-RCTControl: NR69.846
Vidrine et al. (342)Non-RCTV.A.C.®: NR62M16 to F19 ratioNR2059 (21)NRNR
Non-RCTControl: NR60M18 to F25 ratio 2556 (27) 
Stone et al. (133)Non-RCTV.A.C.®: 1735.4 ±14NRNR21105.6 (88)Wound Site:

Face:1
Torso: 3
Extremity: 17

NR
Non-RCTControl: 2339.0 ±16.7  25150.2 (78) 
Scherer et al. (132)Non-RCTV.A.C.®: 3433 ±23NRNRNRGraft size, cm2
387 ±573
NRNR
Non-RCTControl: 2741 ±20   984 ±996 
Genecov et al. (131)Non-RCT10Range: 39 to 81M4
F6
Paraplegia: 2
Diabetes mellitus: 4
Systemic infections: 2
Hemodialysis dependence: 3
Traumatic wounds: 3
1032-380 cm2NRNR

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

ReferenceStudy TypeTreatmentsTreatment ChangeWound AssessmentFrequency of MeasurementsTreatment DurationPrior TreatmentsConcurrent Treatments
Vuerstaek et al. (115)RCTV.A.C.®

Continuous Negative Pressure (CNP): -125 mmHg

Foam dressing

Day 4NRTwice a week until wound closureWound 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
RCTControl

SOC according to SIGN guideline and compression therapy

Day 4 
Moisidis et al. (112)RCTV.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 weeksNRGraft 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.
RCTControl
Mepitel, Acriflavice wool and foam sponge
Korber et al. (340)Non-RCTV.A.C.®

Black sponge

-125 mmHg

1st between postoperative day 5 or 7NRBetween day 10 and 14Mesh graft takeNRPostoperative compression therapy for patients with venous leg ulcer or a mixed ulcer
Control    
Vidrine et al. (342)Non-RCTV.A.C.®/ControlRemoved between day 4 and 6Senior authorDay 7 (1 week) and week 44 weeksNRNR
Stone et al. (133)Non-RCTV.A.C.®/controlNRNRNRCompletely successful graft takeNR 
Scherer et al. (132)Non-RCTV.A.C.®
CNP: -125 mmHg
4th postoperative day unless signs suggested infectionNRNRSuccessful graft takeNRBed rest, a sling, or a splint
Control
Genecov et al. (131)Non-RCTV.A.C.®Days 4 and 7Blinded assessor analyzed biopsies Degree of re-epithelializationNRNR
Control3.33

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

ReferenceStudy TypeTreatmentsNWounds HealedMean (SD) Change in Wound Area (cm2) or Volume (cm3)Satisfactory HealingOther Important OutcomesAdverse Events Resulting in Discontinuation of Treatment
Vuerstaek et al. (115)RCTV.A.C.®3029NR

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
RCTControl3029 

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

Moisidis et al. (112)RCTV.A.C.®20 patients used as own controls20NR

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%)

NRNR
Korber et al. (340)Non-RCTV.A.C.®

NR
(28 wounds)

26NRMesh graft take rate: 92.9%NRNR
Non-RCTControl

NR
(46 wounds)

31 67.4% 
Vidrine et al. (342)Non-RCTV.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%NRNR
Non-RCTControl

NR
(25 wounds)

25

Average graft take at 1 wk: 97%

Average graft take at 4 wk: 81

Overall complete STSG take rate: 52% 
Stone et al. (133)Non-RCTV.A.C.®

17
(21 grafts)

Graft take: 100%n/a

Duration of dressing:
4.8 ±0.8

Mean hospital stay:
20.9 ±10

NR
Non-RCTControl

23
(25 grafts)

1 graft failure 5.2 ±2.415.3 ±7.5
Scherer et al. (132)Non-RCTV.A.C.®34NRNR

Graft take, %
96 ±6

Repeat STSG to same site 1 (3%)

Total LOS, d 27 ±16

NR
Non-RCTControl27  89 ±20

Repeat STSG to same site 5 (19%)

Total LOS, d 32 ±25

Genecov et al. (131)Non-RCTV.A.C.®/ Control10 (used as own controls)10NR

V.A.C.® re-epithelialize faster than control: 7

No difference in rate of re-epithelialization: 2

More rapid re-epithelialization with OpSite: 1

NRNR

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

ReferenceStudy TypeWound TypeNumber of Patients EnrolledComparison TreatmentInclusion CriteriaExclusion CriteriaLength of StudyAttrition
Stannard et al. 2006 (125)RCTPostoperative woundsStudy 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.

NRNR
Timmers et al. (106)Non-RCTPost-traumatic osteomyelitis124SOCConsecutive patients with osteomyelitis with one recurrence who presented at the Leiden University Medical Center between March 1999 and February 2003.NRUntil 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-RCTDeep sternal62Conventional (debridement, chest rewiring, closed irrigation)Patients undergoing treatment for deep sternal wound infection from March 2002 to December 2007NR1 year follow upNR
Yang et al. (72)Non-RCTFasciotomy68Saline-soaked wet-to-dry dressingsPatients who underwent two-incision fasciotomies for documented, traumatic compartment syndrome of the leg with the release of all four compartmentsNRTime to definitive closure by either delayed primary closure with sutures or split-thickness skin graft coverageNR
Fuchs et al. 2005 (23)Non-RCTDeep sternal68ConventionalIncidence 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 PreventionNRFollow 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 sternumNR
Immer et al. 2005 (130)Non-RCTDeep sternal wound infection (DSWI)55Sternal excision and musculocutaneous flapPatients 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.NRNRNR
Segers et al. 2005 (122)Non-RCTPost sternotomy mediastinitis (PM)63Closed drainage technique (CDT)All patients treated from PM after cardiac surgery at the Academic Medical Center between 1/1/92 and 12/31/03NRNR29% (18 deaths; 9 NPWT, 9 control)
Sjogren et al. 2005 (139)Non-RCTPM101Conventional (open dressings, closed irrigation, pectoral muscle flaps or omentum flaps)At least one of the following CDC criteria for PM:
  1. An organism isolated from culture of mediastinal tissue or fluid
  2. Evidence of mediastinitis was seen during operation;
  3. 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 infectionsNRNR
Domkowski et al. 2003 (129)Non-RCTPM102Standard of Care (SOC)Between 1997 and 2002, patients from Duke University Hospital, The Durham VA HospitalPatients with superficial wound infections or fat necrosisNRNR
Song et al. 2003 (124)Non-RCTSternal35SOC35 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 sternumNRNRNR
Doss et al. 2002 (128)Non-RCTPost-sternotomy Osteomyelitis42SOCPatients treated for post-sternotomy Osteomyelitis (SOM) between 1998 and 2000NRNRNR
Catarino et al. 2000 (137)Non-RCTPost-sternotomy mediastinitis (PM)17Closed 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 dehiscencesUntil wound closureNR
Shilt et al. 2004 (138)Non-RCTTraumatic Wounds31Standard 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 injuriesLargest diameter of the wounds was <2 cm or if wound care consisted of primary closureUpon wound healing or further reoperation1 control lost to f/u
Kamolz et al. 2003 (343)Non-RCTBurn7Silver sulphadiazine crèmeAll patients of the last 5 months with bilateral partial thickness hand burnsPatients not admitted within the time interval of 6h after trauma; children <20 years of age, pregnant, and patients with a history of allergic reactionsUpon further reoperation or wound healNR
Gabriel et al. 2008 (339)Non-RCTInfected30SOCTrunk 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

NRUntil wound closureNR
Ozturk et al. 2008 (117)Non-RCTFournier's gangrene10SOCBetween January 2006 and August 2007 patients with Fournier's gangrene and treated at the Dept of General Surgery, Uludag University School of Medicine, Bursa, TurkeyNRTime to wound closureNR
Rinker et al. 2008 (121)Non-RCTOpen Tibia Fracture105 (55 subacute analyzed)SOCHospital 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.NRNRNR
Huang et al. 2006 (127)Non-RCTLimb24SOC (gauze soaked with saline)A diagnosis of acute necrotizing fasciitisNRNRNR
Labler et al. 2004 (71)Non-RCTSoft-tissue23Epigard® dressingPatients 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 traumaAll type IIIC fractures due to associated valcular injuries12 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

ReferenceStudy TypeNumber of PatientsMean (SD) Age (years)SexComorbiditiesNumber of WoundsMean (SD) Baseline Wound Area (cm2) or Volume (cm3)Severity of WoundsMean (SD) Duration of Wound
Stannard et al. (125)RCT

Hematoma study: 44

V.A.C.®: 13

48 yrs (21-96)

M 36

F 8

NR44NRInjury Severity Scores (ISS) 14.1<5d
RCTControl: 3113.9
RCT

Fracture study:

V.A.C.®: 20

41 yrs (19-78)

M 32
F 12

NR20NR

ISS
11.1

NR
RCTControl: 242410.1
Timmers et al. (106)Non-RCTV.A.C.®: 3052 (26-81)

M14
F16

18 (60%) diabetes mellitus, smoker, cardiovascular disease, pulmonary disease

30NRNRNR
Control: 9447 (9-85)

M58
F36

54 (57.4%) diabetes mellitus, smoker, cardiovascular disease, pulmonary disease

94
Simek et al. (123)Non-RCTV.A.C.®: 3466.4 ±9.8

M 52%
F 48%

Diabetes mellitus: 52.9%
COPD: 32.4%
Immunosuppressive therapy: 14.7%
Renal impairment: 23.5%

34NRNRNR
Non-RCTControl: 2871.2 ±7.9

M 68%

F 32%

Diabetes mellitus 60.7%
COPD: 25%
Immunosuppressive therapy: 10.7%
Renal impairment: 35.7%

28
Yang et al. (72)Non-RCTV.A.C.®: 34NRNRNR68NRNRNR
Control: 3470
Fuchs et al. (23)Non-RCTV.A.C.®: 3568.5 (63.9-74.5)M 76%

Diabetes—55%
Coronary heart disease—97%

35NR

Type I: 0
Type II: 9
Type IIIa: 12
Type IIIb: 10
Type V: 4

NR
Non-RCTControl: 3368.5 (64.4-74.9)M 85%

Diabetes—59%
Coronary heart disease—97%

33NR

Type I: 4
Type II: 1
Type IIIa: 17
Type IIIb: 4
Type V: 7

NR
Immer et al. (130)Non-RCTV.A.C.® only: 1960.1 ±11.8

M 13

F 6

COPD: 1 (5.3%)
Diabetes: 7 (36.8)
Immunosuppression: 2 (10.5%)
Arterial hypertension: 13 (68.4%)

19NRNRDiagnosis DSWI (days) 17.5 ±5.1
Non-RCTV.A.C.® plus Excision and flap: 1966.6 ±7.2

M 14

F 5

COPD: 3 (15.8%)
Diabetes 10 (52.6%)
Immunosuppression: 1 (5.3%)
Arterial hypertension: 14 (73.7%)

19NRNR71.7 ±213.7
Non-RCTExcision plus flap: 1769.5 ±8.1

M 10

F 7

COPD: 6 (35.3%)
Diabetes: 7 (41.2%)
Immunosuppression: 0
Arterial hypertension: 17 (100%)

17NRNR36.7 ±46.5
Segers et al. (122)Non-RCTV.A.C.®: 2965.9 (38-81)

M 17

F 12

Diabetes: 11 (37.9%)
COPD: 10 (34.5%)

29NR

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
Non-RCTControl: 3466.7 (20-81)

M 30

F 4

Diabetes: 8 (23.5%)
COPD: 6 (17.6%)

34NR

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-RCTV.A.C.®: 6167.3 (10.1)

M 44

F 17

Diabetes: 26 (43%)
Obesity: 23 (38%)
LVEF <0.30: 14 (23%)
COPD: 12 (20%)

61NR

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
Non-RCTControl: 4068.9 (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-RCTData only reported for total study populationNRNRNRNRNRNR
Song et al. (124)Non-RCTV.A.C.®: 1763 (31-88)

M 10

F 7

CABG: 14
Valve: 1
Aortic dissection: 3
Mediastinitis: 15
Chronic infection: 2
Sterile wound:1

17NRNRUp to 6 weeks
Non-RCTControl: 1863 (23-77)

M 14

F 4

CABG: 13
Valve: 2
Heart transplant: 1
Pericardiectomy: 1
Mediastinitis: 13
Chronic infection: 3
Sterile wound:1

18NR 
Doss et al. (128)Non-RCTV.A.C.®: 20Median: 66 (45-82)

M 9

F 11

Bilateral internal mammary artery: 5
Diabetes: 9
COPD: 4
Overweight: 7

20NRNRPostoperative presentation:
day 7 to 21
Non-RCTControl: 2266 (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-RCTV.A.C.®: 768 (64-74)

M 5

F 2

Coronary heart disease; diabetes; and high BMI7NRNRNR
Non-RCTControl: 1066 (46-75)

M 7

F 3

Coronary heart disease; diabetes; and high BMI10  
Shilt et al. (138)Non-RCTV.A.C.®: 163.9 (1-8)

M 10
F 6

NR16NRWith fractures—12NR
Non-RCTStandard of Care (SOC): 158.5 (2-18)

M 8
F 7

15With fractures—8
Kamolz et al. (343)Non-RCT

V.A.C.®: 7

Patients used as their own controls

44.2 (22.4)NRNR14NRPartial thickness<6h
Non-RCTSilver sulphadiazine crème (SSD): 7
Gabriel et al. (339)Non-RCTV.A.C.®: 1557.13 ±11.64NR

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

15127.33 ±137.87NRNR
Non-RCTStandard of Care (SOC): 1559.40 ±10.29 

Necrotizing fasciitis—4
Pressure ulcer—5
Open joint—6

15173.00 ±123.73  
Ozturk et al. (117)Non-RCTV.A.C.®: 556 (33-77)

M 4
F 1

NR5NR

3 local
2 disseminated

NR
Non-RCTV.A.C.®: 556 (31-64)

M 3
F 3

 5 

3 local
2 disseminated

 
Rinker et al. (121)Non-RCTV.A.C.®: 17Median: 40 (Range: 11-64) NR60 flapsNRNRSubacute wounds had flap performed on post-injury days 8 to 42
Non-RCTControl: 38
Huang et al. (127)Non-RCTV.A.C.®: 1257.75

M 7

F 5

Diabetes—6
Fever—6
Leukocytosis—7
Shock—3
Trauma—3
Infection- 9

12Wounds varied between 30 and 15 cm in length and 13 and 3 cm in widthNRNR
Non-RCTSOC: 1262.58

M 9

F 3

Diabetes—9
Fever—9
Leukocytosis –6
Shock—2
Trauma—4
Spontaneous infection—8
12Wounds varied between 32 and 12 cm in length and 12 and 4 cm in width  
Labler et al. (71)Non-RCTV.A.C.®: 12Range: 18-68M 8
F 4
NR14NRMangled Extremity Severity Score:
2 (n = 1); 3 (2); 4 (3); 5 (4); 6 (2); 7 (2)
 
Non-RCTControl: 11Range: 20-89M 8
F 3
NR12NRMangled 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

ReferenceStudy TypeTreatmentsTreatment ChangeWound AssessmentFrequency of MeasurementsTreatment DurationPrior TreatmentsConcurrent Treatments
Stannard et al. (125)RCT

Hematoma study:
V.A.C.®

At least every other dayNRNRUntil cessation of drainage of hematomaNRIf drainage continued at day 10, patients returned to the OR for an evacuation of the hematoma with irrigation and debridement
RCTDressingDaily  
RCT

Fracture study:
V.A.C.®

NRNRNRWound drainage had dropped to grade 3 or belowNRNR
RCTControl   
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 daysWound culturesEach dressing changeUntil 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
ControlNRNR    
Simek et al. (123)Non-RCTV.A.C.®NRNRNRWound 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 reclosedNRNR
Non-RCTControl
Yang et al. (72)Non-RCTV.A.C.®: CNP: -125 mmHgEvery 48 hoursNRNRUntil wound closure by delayed primary fashion or covered with STSGNRIrrigation and debridementNR
ControlNR
Fuchs et al. (23)Non-RCT

V.A.C.®

CNP: -125 to
-150 mmHg

With severe pain, -75 mmHg

3 polyurethane foam sponges

3-7dNRNRFreedom of the sternal wound from microbiological culturesNR
  • Wound incision and removal of sternal wires
  • Aggressive debridement
Non-RCTControlNR 
  • 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 hrsBacteriologic culturesNRNRNR
  • Intravenous antibiotics
  • Debridement every 48-72 hours
Non-RCTV.A.C.® plus secondary sternal excision and musculocutaneous flap
Non-RCTSternal excision + flap
Segers et al. (122)Non-RCT

V.A.C.®

Continuous Negative Pressure (CNP): -125 mmHg

Foam dressing

Initially after 48h; thereafter every 4-5dNRNRA 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 performedNR
  • Aggressive debridement
Non-RCTControlNR
Sjogren et al. (139)Non-RCTV.A.C.® NRNRWound 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 flapNR
  • Surgical debridement
Non-RCTControlSeveral times daily
Domkowski et al. (129)Non-RCTV.A.C.®NRNRNRNRNR
  • Debridement
SOCNRNRNRNRNR
  • Debridement
Song et al. (124)Non-RCT

V.A.C.®

CNP: -75 to
-125 mmHg

Foam dressing

Every other dayPlastic surgery and physical therapy staffNRDefinitive closure determined by the gross appearance of the wound and hemodynamic stability of the patientNR
  • Surgical debridement
  • Antimicrobial layer of Acticoat* (Smith & Nephew)
Non-RCTControlTwice a day
  • Surgical debridement
  • Topical antimicrobial agent
Doss et al. (128)Non-RCT

V.A.C.®

-125 mmHg

Foam dressing

Every 2-3dNRNRPrimary closure after granulation tissue filled the defect and all microbiological cultures were negativeNR
  • Debridement
Non-RCTControlNR
Catarino et al. (137)Non-RCT

V.A.C.®

CNP 125 mmHg

Foam dressing

48-72 hrsNRNRUntil wound closure; evident granulation tissue and negative microbiological culturesNR
  • Debridement
  • Broad-spectrum antibiotics
Non-RCTControl 
Shilt et al. (138)Non-RCTV.A.C.®Every 72 hoursNRNR16.7dAmputation 11

Oral antibiotics (9)
Intravenous antibiotic (15)

Non-RCTControl  14 
Kamolz et al. (343)Non-RCT

V.A.C.®

Open-cell polyurethane foam

Controlled dailyUse of Indocyanine Green (ICG) video angiographiesDailyNRNRIntravenous injections of 0.2 mg/kg ICG
Non-RCTControl
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

NRNRWeeklyUntil wound closureNR
  • Repeatedly sharply debrided
Non-RCTControlNR
Ozturk et al. (117)Non-RCT

V.A.C.®

CNP 125 mmHg

GranuFoam® large dressing

Every 72 hrs in the ORNRNRAfter wounds were clinically healed or wound cultures were negative, tertiary wound closure or split thickness grafting was performedNR
  • Surgical debridement
Non-RCTControlDaily or more if needed
  • 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 hoursNRNRNRNRNR
Non-RCTControl (wet-to-dry gauze or a moist occlusive dressing)NR     
Huang et al. (127)Non-RCT

V.A.C.®

Intermittent: -125 mmHg

48-72 hrsNRNRHealed completely or when a minor procedure for closure was required, i.e., simple wound stitching or skin grafting Mean debridement per patient: 4.41
Non-RCTControl3-6x/d3.33
Labler et al. (71)Non-RCTV.A.C.® Foam
CNP - 125 mmHG
Every 48 hours depending on wounds and patient's conditionBacterial culturesEvery 48 hoursUntil primary or secondary closureNR
  • 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-RCTControl

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

ReferenceStudy TypeTreatmentsNWounds HealedMean (SD) Change in Wound Area
(cm2) or Volume (cm3)
Satisfactory HealingOther Important OutcomesAdverse Events Resulting in Discontinuation of Treatment
Stannard et al. (125)RCTHematoma study:
V.A.C.®
1313NRDrainage (Mean)

1.6 (Range: 0-5)

Need for surgical evacuation:
1 (8%)
NR
RCTControl:31313.1 (Range: 0-11)5 (16%)
RCTFracture study:
V.A.C.®
2020NRDrainage (Mean):
1.8 (0-6)
No significant difference in rates of infection or wound dehiscenceNR
RCTControl2424 4.8 (0-24)
Timmers et al. (106)Non-RCTV.A.C.®3030NR7 (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
Control94 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)

Simek et al. (123)Non-RCTV.A.C.®34NRNR5.8% failure rateOverall length of therapy:14.9 ±7.9d
In-hospital mortality 5.8%
1-year mortality: 14.7%
NR
Non-RCTControl28  39.2% failure rateOverall 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)
NRNR
Control34

Wounds healed (70 (100%))

Ratio of wound closure to skin-grafted wounds: 45:25
 
Fuchs et al. (23)Non-RCTV.A.C.®3534NRPrimary 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
Non-RCTControl3329 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-RCTV.A.C.®19NRNRNR

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-RCTV.A.C.® plus excision plus flap19    
Non-RCTExcision plus flap17    
Segers et al. (122)Non-RCTV.A.C.®2921 (73%)NRTherapy duration (d):
22.8 (4-68)
Hospital stay SSI (mean):
46.1 (Range: 10-74)
Mortality caused by SSI: 4 (13.8%)
Non-RCTControl3414 (41%) Therapy duration(d):
16.5 (2-38)
35.7 (Range: 10-165)7 (20.6%)
Sjogren et al. (139)Non-RCTV.A.C.®6161NRTreatment 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
Non-RCTControl4040 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-RCTV.A.C.®96NRNROmental transposition: 33
Pectoralis flap: 10
Secondary closure: 53
NRMultisystem organ failure: 2
Overwhelming Sepsis: 2
Non-RCTControl6     
Song et al.(124)Non-RCTV.A.C.®1715 (14 by definitive closure; 1 by secondary intention (V.A.C.®))NRAverage days between initial debridement and definitive closure of the sternal wound (not significant)
6 ±1.3d
NRMortality:
3 (2 from aspiration pneumonia and
1 from multisystem organ failure)
Non-RCTControl1817 8 ±2.9d Mortality:
1 patient died due to aspiration pneumonia
Doss et al. (128)Non-RCTV.A.C.®20NRReduction in wound size:
4.63 cm2/day (Range: 2.9-6.5)
NRDuration of treatment:
Mean: 17.2 ±5.8

Total hospital stay:
Mean: 27.2 ±6.5d

Hospital mortality: 1 (5%)
Non-RCTControl22 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-RCTV.A.C.®77NR11d median (6-26d)LOS: 27d median (22-49)

Treatment failure: none (significantly greater for Control)

NR
Non-RCTControl10  13d median (8-20)LOS: 50d median (27-98)

Treatment failure: 5

 
Shilt et al.(138)Non-RCTV.A.C.®1616NRFree 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
Non-RCTStandard of Care (SOC)1515Free 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)

Kamolz et al.(343)Non-RCTV.A.C.®7 patients used as own controls14NRSkin grafts —2;
No operation —3;
Keratinocytes—2
A massive reduction of edema formation (up to 50 ml) within the burn woundNR
Non-RCTSilver sulphadiazine crème   Skin grafts—4;
No operation —3
  
Gabriel et al.(339)Non-RCTV.A.C.®15100%NRDays to wound closure:
13.20 ±6.75
Days to patient discharge:
14.67 ±9.18
NR
Non-RCTControl1566.7% 29.60 ±6.5439.20 ±12.07 
Ozturk et al.(117)Non-RCTV.A.C.®55NR9d (Range: 7-15)VAS 2.4
LOS: 14d; Range: 11-19
NR
Non-RCTControl55 10d (8-16)VAS 6.8
LOS: 13d;10-18
 
Rinker et al.(121)Non-RCTV.A.C.®17 (17 flaps)17 (100%)NRTime to bony union (Significantly less)
4.9 months
LOS, days
20.8 ±10.5
NR
Non-RCTControl38 (43 flaps)36 (84%) 7.2 months20.2 ±8.5
Huang et al.(127)Non-RCTV.A.C.®12NRReduction:
47% in dimension and 49% in volume
NRHospital stay:
32.1d (mean)
Deaths: 1 (8%)
Amputation: 2
Non-RCTControl12 Reduction:
41% in dimension and 39% in volume
 34.3d (mean)Deaths: 1 (8%)
Amputation: 2
Labler et al. (71)Non-RCTV.A.C.®1211NR11 of 13 healed uneventfullyRate of infection:
2 of 13
Early amputation; 1
Non-RCTControl115NR5 of 10 healed uneventfullyRate of infection: 6 of 11Early 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

ReferencePatient Population (n)Age (yrs)SexComorbiditiesWound TypeNumber of WoundsWound Area (cm2) or Volume (cm3)Severity of Wounds
Bannasch et al. 2008 (344)5Mean 37.8, Range: 8-584 M
1 F
1: DMPretibial 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 leg5NRNR
Bendewald et al. 2007 (82)5Median: 21 Range: 16-633 M
2 F
NRComplex pilonnidal disease underwent wide excision5Mean: 205 cm3 Range: 90 cm3-410 cm3 NR
Bendo et al. 2007 (76)13Mean: 58
Range: 34-83
5 M
8 F
6: diabetes 1: atrial fibrillation 1: HIVPosterior lumbar wound drainage management of the spine prior to debridement13NRNR
Brandi et al. 2008 (345)18Avg: 56,
Range: 45-78
NR12: Peripheral vascular disease (PVD) and 4 of these with type 2 DMTraumatic loss of tissue in the lower limbs involving exposure of bone and tendon structures18NRNR
Dhir et al. 2008 (346)19Mean: 63.2, Range: 48-7517 M
2 F
16: hypertension
4: IDDM
9: malnutrition
7: CAD
7: PVD
4: NIDDM
Complex head and neck wounds33Larger cutaneous defects >10 cm2Neck and facial abscesses
Rhode et al. 2008 (347)5Mean: 41.2, Range: 33-595 FBMI Range: 24.4 -36.1
2: smokers
Patients had radical excisional therapy for stage III vulvar hidradenitis suppurativa5NRNR
Rozen et al. 2008 (348)9Mean: 69,
Range: 32-99
9 F5: 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 grafts9NRNR
Steiert et al. 2008 (349)42Mean: 46,
Range: 15-84
29 M
13 F
NROpen extremity fractures33 lower extremity
10 upper extremity
NRSevere extremity trauma
Svensson et al. 2008 (149)28Median: 75, Range: 48-88Of the 33 wounds, 21 M
12 F
10: ≥80 yrs
12: women
14: DM
23: lower limb ischemia
Perivascular surgical site infections in groin33NRInfected groins
Bhattacharyya et al. 2007 (350)38Infected Mean: 39 ±8.8

Non-infected Mean: 39 ±10.5

32 M
6 F
7: smokers
1: DM
Gustilo grade III B open fractures3810 cm or larger11 wounds infected;
27 non-infected
Bollero et al. 2007 (141)35Avg: 40,
Range: 14-72
29 M
6 F
NRAcute complex traumas of lower limbs13 foot
5 ankle
15 leg
1 knee
3 thigh
NRNR
Dedmond et al. 2007 (27)49Avg: 36.8, Range: 18-7040 M
10 F
NRGrade/type III open tibial shaft fractures24 IIIA 24 IIIB 2 IIICNRNR
Helgeson et al. 2007 (351)NRNRNRNRExposed 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)13Range: 13-7110 M
3 F
NRSevere soft tissue injuries as a result of high energy pelvic trauma13NRNR
Machen 2007 (74)Over 50 patientsNRNRNRTraumatic war woundsOver 50 woundsNRNR
Peck et al. 2007 (353)192Range: 4-68NRNRMajor vascular injuries134 extremity
33 neck and vessel
25 torso
NRNR
Rao et al. 2007 (163)29Median: 60, Range: 31-8014 M
15 F
NROpen abdominal wounds29NRNR
Segers et al. 2007 (354)5NRNRNROpen window thoracostomy5NRNR
Senchenkov et al. 2007 (355)17Mean: 65,
Range: 42-82
9 M
8 F
17: soft tissue sarcoma
2: DM
1: smoker
Irradiated extremity wounds reconstructed w/split thickness skin grafts17Skin graft size:

Mean: 118 cm2

Range:
23-240 cm2

NR
Andrews et al. 2006 (88)12Average: 61.8 Range: 34-868 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 wounds13All in cm: 8x6 10x5 7x6 9x6 5x4 9x6 16x8 8x9 21x14 14x8 10x9 10x79: Bone exposure
Cothren et al. 2006 (356)14Men:
Mean: 41 ±5.7
79% M, 21% FNROpen abdomen14NRNR
DeFranzo et al. 2006 (156)100Range: infancy to 7848 M
52 F
NRPartial thickness and complete full-thickness abdominal wounds63 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)21Mean: 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 dehiscence21NRNR
Leininger et al. 2006 (111)77NRNRNRHigh-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)18Range: 13-6916 M
2 F
NROpen abdomen after laparotomy18NRNR
Rosenthal et al. 2005 (89)23Average: 5917 M 6 F4: Diabetes requiring insulin therapy during wound managementHead and neck reconstruction23NRNR
Stoeckel et al. 2005 (358)18Mean: 5218 F2: smokers
4: previous radiation therapy to affected breast
Complex breast wounds15NRNR
Savolainen et al. 2004 (359)36Median: 72, Range: 46-9821 M
15 F
NR
Inguinal wound in vascular surgery36
NR13 frank infection
11 non-infected
12 clinically contaminated
Stone et al. 2004 (90)48NRNRNRAbdominal trauma48NRNR
Herscovici et al. 2003 (360)21Avg: 45.9, Range: 16-8312 M
9 F
NRHigh energy soft tissue injuries6 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)15NR12 M
3 F
NRAbdominal wounds15NRAbdominal compartment syndrome, inability for abdominal closure at initial operation, or inability to close the abdomen upon re-exploration
Suliburk et al. 2003 (166)29Men:
Mean: 38 ±3
20 M
9 F
NROpen abdomen after severe trauma29NRNR
Garner et al. 2001 (86)14Mean: 40.1 + 4.74 M
10 F
NROpen abdomens14NRNR
DeFranzo et al. 2000 (157)75NRNRNRLower extremity wounds w/ exposed bone29 motor vehicle accidents
9 gunshot
11 other assorted trauma
13 dehisced or infected orthopedic surgical wounds
3 pressure sores
5 failed flaps
5 miscellaneous
NRNR
Avery et al. 2000 (92)15NRNRNRRadial forearm donor site with split skin graft15Mean: 36 cm2 NR

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

ReferencePatient Population (n)Age (yrs)SexComorbiditiesWound TypeNumber of WoundsWound 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 infections28 superficial 21 deepNRNR
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 Fascitis16NRNR
Chen et al. 2008 (160)26Mean: 69, Range: 49-8221 M
5 F
 Deep sternal wound infections26NRNR
Ennker et al. 2008 (361)45Avg: 6829 M
16 F

16: IDDM
35: hyperlipidemia
40: hypertension
19: COPD
7: Peripheral arterial disease
9: Carotid artery stenosis

Deep sternal wound infections452 cm x 2 cm to 2 cm x 18 cmNR
Fleck et al. 2008 (362)22Mean: 61.5 ±15,
Range: 8-79
15 M
7 F
NROpen chest22NRNR
Gdalevitch et al. 2008 (154)36Median: 67.1, Range: 49-8822 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 wounds36Depth:

19.4% ≥4 cm
80.6% ≤4 cm

NR
Ha et al. 2008 (140)74Median: 65.5, Range: 19-9540 M
34 F
60.8% DM
86.7% of DM had PVD, Stroke, retinopathy, dialysis
Surgical wounds25 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)10Mean: 65 ±165 M
5 F
6: DM
7: hypertension
Lymphatic fistulas (LFs) and lymphoceles: 9 patients groin lymphatic complications

1 patient neck lymphatic complication

10NRNR
Horch et al. 2008 (155)21Mean: 69.8, Range: 46-8012 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 joints21NRAll patients presented with necrotic tendons and or affected and exposed tibia or fistula bones
Labanaris et al. 2008 (364)80Men:
Mean: 63, Range: 53-84

Women:
Mean: 66, Range: 50-82

64 M
16 F
NRChronic wounds26 pressure ulcers
17 wound trauma
24 diabetic ulcer
13 venous stasis ulcer
NRNR
Lopez et al. 2008 (365)8 with 10 V.A.C.® applicationsAge at V.A.C.® application: 84.5 ±51 days6 M
2 F
NRComplex abdominal wounds8Mean:
13.6 ±6 cm2

Range:
8.5-25 cm2

Wound infection and dehiscence
Mokhtari et al. 2008 (366)38Mean: 69 ±SD 10.629 M
9 F
15: DM
10: BMI >30
9: COPD
16: recent MI
3: Renal Failure
Deep sternal wound infection38NRNR
Ploumis et al. 2008 (80)73Average: 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 smokingSpinal wound infections79NRNR
Wondberg et al. 2008 (161)30Avg: 63, Range: 27-8621 MNROpen abdomen caused by abdominal sepsis; origin of sepsis:

21 colon
3 stomach
5 stomach or bowel
1 unclear

30NRNR
Horn et al. 2007 (78)11Range: 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 wounds11NRRange of time of onset of infection: 2 weeks-5 years
Jones et al. 2007 (150)13Mean: 50.2, Range: 14 -76NSMalignant disease, anemiaDeep infections of the spine13NR6 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)68Mean: 8.5 yrs

Range:
7 days-18 yrs

36 M
32 F
NRPressure ulcers, extremity wounds, dehisced surgical wounds, open sternal wounds, wounds w/fistulas, complex abdominal wall defects13 pressure ulcers
18 extremity wounds
19 dehisced surgical wounds
10 open sternal wounds
3 wounds w/fistulas
6 complex abdominal wall defects
NRNR
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

37NRNR
Shrestha et al. 2007 (367)9Range: 30-675 M
4 F
NRDeep wound infection after renal transplantation9NRDehiscence, 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 infections34NRNR
Van Rhee et al. 2007 (368)6Avg: 12.63 M
3 F
NRDeep wound infection after instrumented spinal fusion in pediatric neuromuscular scoliosis6NRWound dehiscence
Gorlitzer et al. 2006 (369)5Avg: 69, Range: 24-723 M
2 F
1: DM
1: colon cancer, CRF, COPD, heart failure
Descending necrotizing mediastinitis5NRNR
Labler et al. 2006 (370)15Mean: 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 surgery15NRNR
Morgan et al. 2006 (164)9Range: 56-857 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 wounds12

All cm:
3x3

3x4
3x3
3x4
3x3
3x3
3x3
3x3
3x5

Non-healing ulcerations
Pelham et al. 2006 (371)10Mean: 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

108 patients had a wound exceeding 20 cm2Skin 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)5Range: 58-792 M
3 F
1: DM
2: COPD, obesity
Deep sternal wound infection5NRNR
Agarwal et al. 2005 (372)103Avg: 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 wounds103NR16 superficial infections

21 sterile

66 mediastinitis

Cowan et al. 2005 (373)22Mean:
67.9 ±10.9
68.2% MBMI 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 involvement22NR82% dehiscence
59% sternal instability
73% fluid collection by computed tomography
41% osteomyelitis
50% staphylococcus aureus
Lee et al. 2005 (374)9Range: 47-73NRNRRefractory sternal infection:

2 patients type IVA mediastinitis after one failed therapeutic trial

7 patients type IVB mediastinitis after more than one failed therapeutic trial

9NRNR
Mendonca et al. 2005 (375)15Avg: 49.3, 22-809 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 ankle18Avg: 7.41 cm2, Range: 2-10 cm211 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)46Mean:
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 mediastinitis46NRNR
Mehbod et al. 2004 (376)20Avg: 55, Range: 31-8112 M
8 F
3: DM
3: previous splenectomy
10: smokers
1: lupus
1: Hodgkin lymphoma
1: HIV
Deep spine infections w/ exposed instrumentation20NR16 draining wound 4 presented back pain & temperature
O'Conner et al. 2004 (377)17Avg: 43.5, Range: 24-7611 M
6 F
Group I:

1 DM and ESRD and steroids
1 chronic lymphocytic leukemia and prostate cancer
2 HIV positive

Chest woundsGroup I:

7 primary chest wall process

Avg 16x7 cm, Range: 7x3 cm to 21x11 cmGroup I:

4 necrotizing soft-tissue infections
3 penetrating trauma resulting in large contaminated wounds w/ significant loss of chest wall integrity

   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 woundsGroup II:

10 with empyema with extension to chest wall

Avg 16x7 cm, Range: 7x3 cm to 21x11 cmGroup II:

2 with empyema necessitates
6 with postpneumonic empyema
4 with postoperative empyema

Routledge et al. 2004 (378)6Range: 22-653 M
3 F
NRDeep wound infections after heart and lung transplantation6NRNR

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)7Mean: 74, 71-806 M
1 F
4: DM

All: cardiopulmonary bypass

Non-healing infected sternal surgical wound7NRWound dehiscence w/local inflammation followed by cloudy discharge some had low grade fever
Gustafsson et al. 2003 (146)40Median: 68, Range: 49-8726 M
14 F
NRDeep sternal wound infections40NRNR

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)14Average: 48 Range: 21-66NRNROrthopedic infections14

Average: 70 cm2

Range:
22.5-288 cm2

NR
Armstrong et al. 2002 (85)31Mean: 56.1 ± 11.7

24 M
7 F

DiabetesDiabetic foot ulcers31

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)17Avg: 64.48 M
9 F
13: DM
9: IDDM
10: peripheral neuropathy
8: severe PVD
Non-healing wounds of lower extremity5 midfoot/ forefoot
6 ankle/ hindfoot
6 lower limb
NR6 postoperative dehiscence of surgical incision
Fleck et al. 2002 (380)11Median: 64.4, Range: 50-785 M, 6 FNRSternal wound infection11NRNR
Gustafsson et al. 2001 (381)16Male:
Median: 68, Range: 49-82

Female:
Median: 67, Range: 63-73

13 M, 3 FNRDeep sternal wound infections16NRNR
Hersh et al. 2001 (94)16Range: 45-79

6 M
10 F

NRDeep sterna wounds16NRNR
De Lange et al. 2000 (167)Group 1: 23Group 1: Mean: 46,
Range 17-77
NRNRGroup 1: stage IV pressure soresGroup 1: 26NRNR
Group 2: 42Group 2:
Mean: 62,
Range: 20-89
NRNRGroup 2: major postoperative wound infection in abdomen, groin, knee, ankleGroup 2: 42NRNR
Group 3: 19Group 3:
Mean 67,
Range: 46-85
NRNRGroup 3: chest wall dehiscence after cardiac surgery complicated by mediastinitisGroup 3: 19NRNR
Group 4: 13Group 4:
Mean: 44,
Range: 21-80
NRNRGroup 4: subacute woundsGroup 4: 13NRNR
Group 5: 3Group 5:
Mean: 67,
Range: 59-73
NRNRGroup 5: soft tissue defect after radiation therapy, soft tissue defect after subcutaneous leakage chemo, diabetes ulcer on ankleGroup 5: 3NRNR
Deva et al. 2000 (382)30Mean: 50.7, Range: 15.4-88.320 M
10 F
NRWounds 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)82NR68 M
14 F
NRSoft tissue lesions of the ankle and foot82NRNR

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

ReferencePatient Population (n)Age (yrs)SexComorbiditiesWound TypeNumber of WoundsWound Area (cm2) or Volume (cm3)Severity of Wounds
Smith & Nephew Wound Management Unpublished Data (96)132Mean: 57, Range 20 - 9273 M, 58FNR55: 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)30Mean: 72.3, Range: 32-969 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)58Median: 10 yrs,
Range:
10 days-16 yrs
28 M
30 F
NRAcute and chronic18 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 cm3NR
Baharestani et al. 2007 (162)24Median: 11 yrs, Range:
14 days - 18 yrs
10 M, 14 FNRLeg, lumbar/sacral, abdomen, and chest wounds9 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)11Mean: 70.5 Range: 50-8111 FNR

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)26Mean: 54,
Range: 16-91
19 M
6 F
7: DMMechanical trauma, debridement of necrotic tissue, chronic13 chronic

7 debridement of necrotic tissue

6 mechanical trauma

Mean:
55.23 ±55.24 cm2
NR
Wada et al. 2006 (384)29Mean: 59.8, Range: 29-7818 M
11 F
13: DM
11: hypertension
10: CD
3: saphenectomy
2: vasculitis
Complex wounds19 lower extremities
7 sacral ulcers
1 abdomen
1 breast
1 trunk
NRNR
Adamkova et al. 2005 (152)6Range: 54-91NRCD hypertension, anemiaSubacute and chronic wounds2 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

NRNR
Butter et al. 2005 (144)16Avg: 12.1 yrs,
Range:
1 month—18 yrs
7 M
9 F
NR8 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
16NRNR
Caniano et al. 2005 (165)51Group 1:
Avg: 16, Range: 10-20
Group 2, 3, 4: NR
NRGroup 1: 67% obese Group 2, 3, 4: NRGroup 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
NRNR
Antony and Terrazas 2004 (385)42Sternal: 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 wounds12 sternal with variety of infections

14 lower extremity w/ variety of infections

16 spinal

NRNR
Bihariesingh et al. 2004 (386)6Mean: 60.2, Range: 33-763 M
3 F
NRComplex soft-tissue defects following various orthopedic procedures6NRNR
Loree et al. 2004 (387)14Median: 73, Range: 54-906 M, 8 FNRChronic leg ulcers:

9 malleolar
3 foot
2 leg
1 tendon calcaneus

15NRUlcer duration:

5 less than 6 months
6 between 6–24 months
4 between 24–360 months

Weed et al. 2004 (37)25NRNRDMAcute: lower extremity, trauma, sternal wound, and elbow trauma

Chronic: pressure ulcers and diabetic ulcers

26 V.A.C.® applicationsNRSerial quantitative cultures
Molnar et al. 2003 (388)8Mean: 40,
Range: 2-60
NR6: smokers
1: ovarian cancer, pulmonary embolus, chemo
1: DM and bladder cancer
1: CAD
1: hypertension
Complex wounds5 trauma
2 wound dehiscence
1 tumor excision
Mean: 250 cm2Bone exposed in 62.5%

joint exposed in 50%

tendon exposed in 37.5%

bowel exposed in 25%

Schimp et al. 2003 (147)27Median: 51, Range: 21-7727 FBMI 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 patients27Median: 330 cm3, Range:
2-4,400 cm3
NR
Mooney et al. 2000 (79)27

Range:
3 days - 18 years

14 M
13 F

NRAcute extremity wounds, chronic extremity wounds, chronic axial wounds27NRAcute 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)26NR17 M
9 F
NRChronic, acute, and subacute8 acute
7 subacute
11 chronic
NRNR
Argenta and Morykwas 1997 (148)300NRNRNRChronic wounds, subacute, and acute175 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: 17Group A: Mean: 82,
Range: 71-88
Group A:
5 M, 12 F
NRGroup A:
infected sacral pressure ulcers
Group A: 17Group A: Mean: 43 cm3, Range: 12-72Group A:
66% of patients the sacrum was exposed, more than 50% of wounds had active secretions
Group B: 12Group B: Mean: 35,
Range: 24-58
Group B:
5 M, 7 F
 Group B:
acute soft tissue defects
Group B: 12Group B: Mean: 20 cm3, Range: 6-80Group 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: 16Group 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: 16Group 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

ReferenceDeviceDressingPrior TreatmentsWound Preparation and Concurrent TreatmentsLength of Follow-up (months)
Smith & Nephew Wound Management Unpublished Data (96)VISTA™ or EZ-Care™ Smith and Nephew systemsAntimicrobial gauze, non-adherent gauzeNRNR7 days post treatment discontinuation
Baharestani et al. 2008 (93)V.A.C.®GranuFoam®NRNRNR
Bannasch et al. 2008 (344)V.A.C.®NRDoppler probe was placed against the drainage vein with the cuff secured around the vessel with nylon sutures, free flaps were split-skin graftedDoppler probeNR
Bapat et al. 2008 (153)V.A.C.®Polyurethane (PU) foamNRDebridement and antibioticsGroup 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 foamDebridement, skin graftCryo-preserved homologous de-epidermalized dermis (DED)Avg: 10 months
Campbell et al. 2008 (84)VISTA™, or Versatile-1™, or EZ-Care™ Smith and Nephew systemsSaline moistened antimicrobial gauzeNRNRNR
Chen et al. 2008 (160)V.A.C.®PU foamNRDebridement,
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®NRIncision, drainage, debridement; Hyperbaric oxygen treatment, dermal grafts, salivary diversion, regional flap reconstructionNR
Ennker et al. 2008 (361)V.A.C.®NRNRDebridementNR
Fleck et al. 2008 (362)V.A.C.®NRNRNRNR
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
NRNRMean: 12, Range: 3-34
Gdalevitch et al. 2008 (154)V.A.C.®Black PU foamNRNRNR
Ha et al. 2008 (140)V.A.C.®NRNRAntibioticsMedian: 85 days,
Range: 14-698 days
Hamed et al. 2008 (363)V.A.C.®PU foam spongeHeavy dressings and bed restNRMedian: 12, Range: 4-32
Horch et al. 2008 (155)V.A.C.®PU spongeConservative treatment with repeated chemical debridement, 1 biologic debridement, and antibiotic therapySerial surgical debridement, general or spinal anesthesia for dressing changes or injection of 1% lidocaineNR
Labanaris et al. 2008 (364)V.A.C.®NRNRDebridement and intravenous antibioticsNR
Lopez et al. 2008 (365)V.A.C.®GranuFoam®NRNRNR
Mokhtari et al. 2008 (366)V.A.C.®PU foamNRDebridement and irrigationNR
Ploumis et al. 2008 (80)V.A.C.®NRNRIrrigation and debridement for treatment preparation and Intravenous antibiotics throughout treatmentAverage: 14
Range: 12-28
Rhode et al. 2008 (347)V.A.C.®NR4 patients had skin graft approximately 1 week after surgery from lateral thighWound beds irrigated, debrided with sharp curetteAvg: 12.6, Minimum: 7
Rozen et al. 2008 (348)Conventional disposable closed system suction drain w/ associated tubing1Disposable foam baseNRAntibioticsNR
Steiert et al. 2008 (349)V.A.C.®PU spongeFracture fixationInitial debridement of necrotic tissue, perioperative antibiotic therapy minimum of 5 daysNR
Svensson et al. 2008 (149)V.A.C.®PU spongeNRNRMedian: 16
Wondberg et al. 2008 (161)V.A.C.®PU foamNRAntibiotic therapy16 patients
Median: 20.1, Range: 5-40
Baharestani et al. 2007 (162)V.A.C.®18: PU GranuFoam®
5: PVA
1: GranuFoam® silver
NR7 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.®NRNRNRRange: 6-14
Bendo et al. 2007 (76)V.A.C.®NRNRAntibioticsNR
Bhattacharyya et al. 2007 (350)V.A.C.®NRNRSerial debridement approximately every 48 hrs, antibiotics from presentation to 48 hrs after definitive wound closureInfected: 20.6 ±13.2,
noninfected: 14 ±5.5
Bollero et al. 2007 (141)V.A.C.®NRNRDebridementAvg: 265 days, Range: 33-874 days
Dedmond et al. 2007 (27)V.A.C.®NRNRIrrigation, debridement, antibioticsAvg: 19.6
Ferron et al. 2007 (83)V.A.C.®PU foamNRNRNR
Helgeson et al. 2007 (351)V.A.C.®NRNRIrrigation and debridementNR
Horn et al. 2007 (78)V.A.C.®Vers-Foam® and GranuFoam® if necessaryNRDebridements between dressing changes, sedation for dressing changesNR
Jones et al. 2007 (150)V.A.C.®PU spongeNRDebridement & irrigation, antibioticsAt least 90 days
Kotsis and Lioupis 2007 (73)V.A.C.®NRNRNRMean: 17.2 Range: 1-28
Labler and Trentz 2007 (352)V.A.C.®PU foamNRDebridement, antibioticsAvg: 19.8 ±1, Range: 7-38
Machen 2007 (74)V.A.C.®Black spongesNRNRNR
McCord et al. 2007 (142)V.A.C.®White and black foamNRDebridement, intravenous analgesic or general anesthesia, or conscious sedation for dressing changesUp to 7 months after negative pressure therapy start
Mendonca et al. 2007 (143)V.A.C.®NRChronic: debridement and topical destroying gels, regular moist wound healing dressing, maggot debridement therapy, compression bandaging for venous ulcersSystemic antibioticsNR
Peck et al. 2007 (353)V.A.C.®NRNRDebridement, operative washout (during) every 48-72 hoursNR
Perez et al. 2007 (95)V.A.C.®NRNRNR

Avg: 324 days
Range: 70-445

Rao et al. 2007 (163)V.A.C.®GranuFoam®NRNRNR
Segers et al. 2007 (354)V.A.C.®NRNRNRMean: 4.3 yrs,
Range: 53-3,350 days
Senchenkov et al. 2007 (355)V.A.C.®NRSkin graftingDebridementNR
Shrestha et al. 2007 (367)V.A.C.®NSPercutaneous drainage of localized collections and regular change of dressings and antibioticsNRNR
Strecker et al. 2007 (318)V.A.C.®NRNRRadical debridement23 ±13 months
van Rhee et al. 2007 (368)V.A.C.®NRNRSurgical debridement, antibioticsAvg: 25 months, Range: 9-42
Andrews et al. 2006 (88)V.A.C.®PU foamNRSharp debridement between dressingsNR
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 closureNRNR
DeFranzo et al. 2006 (156)V.A.C.®NRNRNR28 had 2 yrs follow-up
Gorlitzer et al. 2006 (369)V.A.C.®NRNRMediastinal necrosectomyNR
Heller et al. 2006 (87)V.A.C.®PU and PVA foamSaline soaked gauze dressings for 1-6 weeksDebridement prior and duringAt least 6
Labler et al. 2006 (370)V.A.C.®PU foamAntibiotics, surgical interventions, implant removal/changeNR14 patients Avg: 28.9,
Range: 15-40
Leininger et al. 2006 (111)V.A.C.®SpongeNRDebridement & operative irrigation, pulsatile lavageAll patients scheduled for f/u in outpatient clinic for 1-12 weeks after discharge
Morgan et al. 2006 (164)V.A.C.®NRTotal contact casting, regular casting, negative pressure therapy, enzymatic debridement, resection of infected bone/soft tissue, mechanical debridement, placement of various biological dressingsNRAvg: 13, Range: 1-21
Pelham et al. 2006 (371)V.A.C.®PU foamNRIrrigation and sharp surgical debridement; intravenous antibioticsMean: 24, Range: 14-32
Sartipy et al. 2006 (151)V.A.C.®PU foamNRNRNR
Wada et al. 2006 (384)V.A.C.®NRNRNRNR
Adamkova et al. 2005 (152)V.A.C.®Black PU spongeNRDebridementNR
Agarwal et al. 2005 (372)V.A.C.®PU spongeNRDebridement, antibioticNR
Butter et al. 2005 (144)V.A.C.®Black or white sponge8 pilonidal sinus
24-48 hours wet to dry dressings
NRAvg: 8
Caniano et al. 2005 (165)V.A.C.®NRNRNRGroup 1: Avg: 13, Range: 8-36
Group 2, 3, 4: NR
Cowan et al. 2005 (373)V.A.C.®PU foamNRIrrigation & debridement, antibioticsNR
Labler et al. 2005 (357)V.A.C.®PU foamNRNRRange: 5-33
Lee et al. 2005 (374)V.A.C.®PU spongeConventional methodsDebridementMean: 35, Range: 5-70
Mendonca et al. 2005 (375)V.A.C.®Open-cell foamSurgically debrided and wound dressing, amputation, antibioticsDebridementAvg: 6.3, Range: 1-18
Rosenthal et al. 2005 (89)V.A.C.®NRNRNRMinimum: 5
Sjogren et al. 2005 (179)V.A.C.®NRNRNRAvg: 2.7 ±1.7 patient years,
Range: 0-5.8 patient years
Stoeckel et al. 2005 (358)V.A.C.®FoamNRNRNR
Antony and Terrazas 2004 (385)V.A.C.®PU foamNROperative and non-operative debridement, pulse lavage irrigation, antimicrobialsNR
Bihariesingh et al. 2004 (386)V.A.C.®Open-cell foamAntibiotics and local wound managementDebridementMean: 514.8 days,
Range: 246-693 days
Loree et al. 2004 (387)V.A.C.®PU ether, open-cell foamMultiple treatment modalities (not specified) and had been treated with at least 3 other modern materials used for debridementDebridement, analgesiaNR
Mehbod et al. 2004 (376)V.A.C.®NRNRIrrigation and debridement, antibiotic therapyAvg: 10, Range: 6-24
O'Conner et al. 2004 (377)V.A.C.®NRNRSedation and analgesia with dressing changesAvg: 7, Range: 3-21
Routledge et al. 2004 (378)V.A.C.®PU foam and PVA foamNRDebridement and antibioticsNR
Savolainen et al. 2004 (359)V.A.C.®Polyvinyl foamNRAnesthesiaNR
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.®NRNRDebridementNR
Demaria et al. 2003 (145)V.A.C.®PU foamConventional therapies, polyvidone-iodine bandages, oral antimicrobial therapySurgical debridement, polyvidone-iodine applied & rinsed at dressing changesNR
Gustafsson et al. 2003 (146)V.A.C.®PU foamNRAntibioticsMedian: 13, Range: 3- 41
Herscovici et al. 2003 (360)V.A.C.®PU ether sterile foamNRSurgical debridementNR
Isago et al. 2003 (91)V.A.C.®PU foamNRNRNR
Molnar et al. 2003 (388)V.A.C.®NRNRIntegra incorporation (artificial skin substitute)NR
Schimp et al. 2003 (147)V.A.C.®Black PU foam or white PVA soft foamNRNRMean: 52 days, Range: 0-270 days
Stonerock et al. 2003 (77)V.A.C.®PU foamNRNR6
Suliburk et al. 2003 (166)V.A.C.®PU spongeNRWashed out at each dressingNR
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 dressing15 serial wound debridement, dressing changes, oral antibiotics
13 operative irrigation and debridement
6 revascularization procedures
5 had amputation
NRNR
Fleck et al. 2002 (380)V.A.C.®PU foamNRDebridement, irrigation with 1 liter of dilute povidone-iodine solution (dressing changes), antibioticsNR
Garner et al. 2001 (86)V.A.C.®PU foamNRNRNR
Gustafsson et al. 2001 (381)V.A.C.®PU foamNRAntibioticsAt least 3 months
Hersh et al. 2001 (94)V.A.C.®PU spongeNRDebridementNR
DeFranzo et al. 2000 (157)V.A.C.®Open-cell foamNRDebridementWounds have been stable from 6 months to 6 yrs
De Lange et al. 2000 (167)V.A.C.®Open-cell PU foamNRDebridement, local or systemic anesthetic (lidocaine 1%)Range: 2-35
Deva et al. 2000 (382)V.A.C.®FoamNRNRAt least 3
Mooney et al. 2000 (79)V.A.C.®NRNRConscious sedation or brief general anesthesia for dressing changesNR
Avery et al. 2000 (92)V.A.C.®Opsite by Smith and NephewNRNRNR
Wu et al. 2000 (158)V.A.C.®PU or PVA foamNRDebridement, non steroidal anti-inflammatory drugs or morphineNR
Lang et al. 1999 (159)Vacuum sealing technique1PVANRDebridementAvg: 13, Range: 3-35
Argenta and Morykwas 1997 (148)V.A.C.®PU ether foamDressing changes, topical treatments, surgical proceduresDebridementNR
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

ReferenceDuration of TreatmentTime to 50% Reduction of Initial VolumePercent Change in VolumeTime to Complete Wound ClosurePercent of Wound Completely HealedHealing of Infected WoundsReduction in Sepsis, Edema, or AmputationSurvivalQuality of Life/ Satisfaction with TreatmentImproved Wound ConditionFacilitation of Surgical Closure
Smith & Nephew Wound Management Unpublished Data (96)XXXXXXX  X 
Baharestani et al. 2008 (93)X    X X XX
Bannasch et al. 2008 (344)X   X X  XX
Bapat et al. 2008 (153)X    X   XX
Brandi et al. 2008 (345)X         X
Campbell et al. 2008 (84)XXX X    X 
Chen et al. 2008 (160)X   XX X XX
Dhir et al. 2008 (346)    X     X
Ennker et al. 2008 (361)X         X
Fleck et al. 2008 (362)X  X   X XX
Gabriel et al. 2008 (383)X  X  X  XX
Gdalevitch et al. 2008 (154)X          
Ha et al. 2008 (140)X   XX X XX
Hamed et al. 2008 (363)X   X    X 
Horch et al. 2008 (155)   X X  XXX
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  XXX   X 
Rhode et al. 2008 (347)X   X    XX
Rozen et al. 2008 (348)X         X
Steiert et al. 2008 (349)X  X     XX
Svensson et al. 2008 (149)X  XXX X XX
Wondberg et al. 2008 (161)X  X  X XXX
Baharestani et al. 2007 (162)X  XXX   XX
Bendewald et al. 2007 (82)X  XX    X 
Bendo et al. 2007 (76)X  X       
Bhattacharyya et al. 2007 (350)   X X   XX
Bollero et al. 2007 (141)X   X    XX
Dedmond et al. 2007 (27)X  XXX   XX
Ferron et al. 2007 (83)X  XXXXXXXX
Helgeson et al. 2007 (351)   X  X  XX
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   XX
Machen 2007 (74)    XXX  XX
McCord et al. 2007 (142)XXX   X  XX
Mendonca et al. 2007 (143)XXX XX  XXX
Peck et al. 2007 (353)   X     XX
Perez et al. 2007 (95)X      XXXX
Rao et al. 2007 (163)X          
Segers et al. 2007 (354)X  X   X   
Senchenkov et al. 2007 (355)X  XX    XX
Shrestha et al. 2007 (367)X   XX   X 
Strecker et al. 2007 (318)X    X   XX
van Rhee et al. 2007 (368)   X X   X 
Andrews et al. 2006 (88)X        XX
Cothren et al. 2006 (356)   X     X 
DeFranzo et al. 2006 (156)X  XXX X XX
Gorlitzer et al. 2006 (369)X        XX
Heller et al. 2006 (87)X     X  XX
Labler et al. 2006 (370)X  XXX   XX
Leininger et al. 2006 (111)   X X   XX
Morgan et al. 2006 (164)    X    XX
Pelham et al. 2006 (371)X  XXX   XX
Sartipy et al. 2006 (151)X      X   
Wada et al. 2006 (384)X  X     XX
Adamkova et al. 2005 (152)X  XXXX  XX
Agarwal et al. 2005 (372)X    X   XX
Butter et al. 2005 (144)X  XX    XX
Caniano et al. 2005 (165)X   X    XX
Cowan et al. 2005 (373)XXXX XXX XX
Labler et al. 2005 (357)X  X XXX XX
Lee et al. 2005 (374)X  XXX   XX
Mendonca et al. 2005 (375)  X XXX  XX
Rosenthal et al. 2005 (89)X        XX
Sjogren et al. 2005 (179)       X   
Stoeckel et al. 2005 (358)X   X    XX
Antony and Terrazas 2004 (385)X  X X   X 
Bihariesingh et al. 2004 (386)X  X     XX
Loree et al. 2004 (387)X X      X 
Mehbod et al. 2004 (376)X  X     XX
O'Conner et al. 2004 (377)X   XX   XX
Routledge et al. 2004 (378)X   XX   X 
Savolainen et al. 2004 (359)X   XX   XX
Scholl et al. 2004 (81)X  XXX   XX
Stone et al. 2004 (90)   X  XX XX
Weed et al. 2004 (37)X   XX   XX
Demaria et al. 2003 (145)X   XX   XX
Gustafsson et al. 2003 (146)X          
Herscovici et al. 2003 (360)X         X
Isago et al. 2003 (91)X X  XX  XX
Molnar et al. 2003 (388)X        XX
Schimp et al. 2003 (147)X X X    XX
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    XX
Fleck et al. 2002 (380)X   XX X XX
Garner et al. 2001 (86)X        X 
Gustafsson et al. 2001 (381)X  X X   XX
Hersh et al. 2001 (94)X    X X XX
DeFranzo et al. 2000 (157)     XX  XX
De Lange et al. 2000 (167)X   XXX  XX
Deva et al. 2000 (382)XXX XX   XX
Mooney et al. 2000 (79)         XX
Avery et al. 2000 (92)X        XX
Wu et al. 2000 (158)X    X    X
Lang et al. 1999 (159)X  XXX   XX
Argenta and Morykwas 1997 (148)X XXXXX  XX
Mullner et al. 1997 (389)X XXXXX  XX

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Table 38. Adverse Events Reported for All Wound Types

ReferencePainBleedingInfection/
Bacterial
Load
MortalityOther
Complications
Smith & Nephew Wound Management Unpublished Data (96)  X  
Baharestani et al. 2008 (93)     
Bannasch et al. 2008 (344)     
Bapat et al. 2008 (153)  XX 
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) XXX 
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) XXX 
Kotsis and Lioupis 2007 (73)     
Labler and Trentz 2007 (352)     
Machen 2007 (74)     
McCord et al. 2007 (142)XX  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)XX   
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

CitationObjectiveSearch StrategyKey Inclusion/ Exclusion CriteriaEvidence Base/
Method of Assessing Study Quality
Participant CharacteristicsOutcomes AssessedResults
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 therapySearches 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 healingStudies 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 burnsThe 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 complicationsPreliminary 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

CitationObjectiveSearch StrategyKey Inclusion/ Exclusion CriteriaEvidence Base/
Method of Assessing Study Quality
Participant CharacteristicsOutcomes AssessedResults
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 centersA 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 ulcersA 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:

  1. A group of examined patients consists entirely or partly of patients with pressure ulcers
  2. The outcome measurement is in any case wound healing in terms of volume and or surface reduction or increase in granulation tissue
  3. 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 ulcersOutcomes 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 woundsLiterature 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 traumaA 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 woundsOutcomes 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 NPWTHTA 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.® therapyMEDLINE, 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 typesMedline, 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:
  1. Does NPWT improve healing of chronic wounds when compared to topical treatments?
  2. Does NPWT improve skin graft survival when compared to other topical treatments?
  3. 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 outcomesSearches 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

CitationObjectiveSearch StrategyKey Inclusion/ Exclusion CriteriaEvidence Base/
Method of Assessing Study Quality
Participant CharacteristicsOutcomes AssessedResults
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 woundsNRArticles 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?

NRArticles were identified by search of PubMed and MedlineIncluded experimental animal studies, RCTs, observations of clinical applications and case reportsStudies:
  • 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 surgeryMedline 1996 to November 2006 using OVID interface, EMBASE 1980 to 2006 Week 52NRStudies:
  • 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 woundsOutcomes 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 NPWTMedline, PubMed and Cochrane databases were searched from 1995-2006.NRStudies:
  • 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 situationsA 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.
NRAuthors 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)
NRNRNR

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 therapyThe 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)

ReferenceContractor 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    XX
ASERNIP 2003           
Augustin 2007           
Avalia-T 2005           
Berg 2000           
Braakenburg 2006           
Catarino 2000 X         
Costa 2005           
Cowan 2005           
Davydov 1994  XX       
Domkowski 2003           
Doss 2002 X  X      
Eginton 2003 X XX    X 
Etoz 2004    X    X 
Evans 2006           
Evans 2001 X         
Fleck 2002           
Ford 2002 XXXX X   X
Fuchs 2005           
Genecov 1998 XXXX      
Greer 1999           
Gupta 2004           
Gustafsson 2002           
Heath 2002           
Higgins 2003 (CCE)           
IQWiG 2006           
Jeschke 2004           
Joseph 2000 XXX  X X X
Kamotz 2004    X      
Llanos 2006           
Loree 2004        X  
Luckraz 2003           
MAAS 2006           
McCallon 2000  XXX 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 XX      
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 XX X   X
Weed 2004        X  
Wild 2004    X      
Willy 2006           
Yang 2006       X   
Total Studies***145916NR43**646

Part II (Pham-Wasiak)

ReferencePham 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 XX 
ASERNIP 2003         X 
Augustin 2007    X      
Avalia-T 2005         X 
Berg 2000   X       
Braakenburg 2006    X XXXX 
Catarino 2000X  X       
Costa 2005           
Cowan 2005   X       
Davydov 1994X          
Domkowski 2003   X       
Doss 2002X          
Eginton 2003X X XXX XX 
Etoz 2004      X XX 
Evans 2006           
Evans 2001           
Fleck 2002   X       
Ford 2002X X XXXXXX 
Fuchs 2005   X       
Genecov 1998X        X 
Greer 1999X          
Gupta 2004           
Gustafsson 2002   X       
Heath 2002X          
Higgins 2003 (CCE)         X 
IQWiG 2006           
Jeschke 2004X     X  X 
Joseph 2000X X XXXXXX 
Kamotz 2004           
Llanos 2006      X XX 
Loree 2004           
Luckraz 2003   X       
MAAS 2006         X 
McCallon 2000X X XXX XX 
McGill 2005         X 
Mendonca 2006    X    X 
Moisidis 2004X     X XX 
Molnar 2004          X
Morris 2007    X      
Moues 2004X X XXXXXX 
OHTAC 2006           
Page 2003         X 
Pham 2006           
Samson 2004    X      
Scherer 2004X        X 
Schrank 2004         X 
Schwien 2005           
Segers 2005   X       
Shilt 2004           
Sjogren 2005   X       
Sjogren 2005           
Song 2003X          
Stannard 2006        XX 
Stone 2004           
Vuerstaek 2006    XXX XX 
Wanner 2003X X XXXXXX 
Weed 2004           
Wild 2004           
Willy 2006         X 
Yang 2006           
Total Studies16NI61014713513251

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

ReferenceWas 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)NNNNNNNNNANNLow
Gregor et al. 2008 (173)CAYYYNNYYYYYHigh
Noble-Bell and Forbes 2008 (70)CAYYYYNNYNANNModerate
Schimmer et al. 2008 (175)CANNYNNNYNANNModerate
Schintler and Prandl 2008 (170) )CANYNNNNNNANNLow
Ubbink et al. 2008 (174)YYYYYYYYNAYYHigh
Ubbink et al. 2008 (183)CAYYYNNYYNANNModerate
van den Boogaard et al. 2008 (107)YYYYNNYYNANNModerate
Vikatmaa et al. 2008 (178)CAYYYNNYYNNYModerate
Kanakaris et al. 2007 (25)CANYYNNNYNANYModerate
Raja and Berg 2007 (186)YNYNNNNNNANNLow
Vlayen et al. 2007 (180)CAYYYYYYYNANNModerate
Wasiak and Cleland 2007 (172)YYYYYYYYNAYYHigh
Mendonca et al. 2006 (187)CANYNNNNNNANNLow
Ontario Health Technology Advisory Committee (OHTAC) 2006 (184)NNYYYYYYNANNModerate
Pham et al. 2006 (176)YYYYNNYYNANNModerate
Costa et al. 2005 (181)CANYYNNNNANANNModerate
Gray & Peirce 2004 (177)CANYYNNYYNANNModerate
Gupta & Cho 2004 (188)NNNYNNNNNANNLow
Samson et al. 2004 (182)CAYYYYYYYNANNModerate

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

ReferenceIncluded StudyWound TypeTreatment(s)ComplicationComorbidities
Contractor et al. 2008 (185)Trop 2006BurnNPWTMassive hematoma in 2 burn patients in the absence of anticoagulation therapy in both a graft and a graft-donor siteNR
Baharestani 2007Open fracture, abdominal compartment syndrome, sacral, sternal, degloving injuryNPWTEnterocutaneous fistula developing in a patient's exposed bowelNR
McCord 2007Pressure ulcers, extremity, dehisced surgical, sternal, fistulas, abdominal defectsNPWT6 wounds failed to healIncluded infection, an enterocutaneous fistula, and/or immunosuppression
Gregor et al. 2008 (173)Armstrong 2005DFUNPWTInfections—more common in NWPTNR
Standard of care 
Noble-Bell and Forbes 2008 (70)McCallon 2000DFUNPWTBleeding and pain at time of dressing changeNR
Etoz 2004NPWTBleeding and pain at time of dressing change
Eginton 2003NPWTWithdrawal due to incorrect pressure setting (too low)
Schimmer et al. 2008 (175)Segers 2005Post-sternotomy mediastinitisV.A.C.® NR
Primary closure with suction/ irrigation systemHigher rates of recurring infection, therapeutic failure at discharge
Ubbink et al. 2008 (174)Joseph 2000ChronicTNP vs. gauze3 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 significantNR
Vuerstaek 2006Chronic ulcersTNP vs. choice of hydrocolloid or alginate dressingNo 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 2003SternalV.A.C.®Subcutaneous fistulas—3NR
Domkowski 2003SternalV.A.C.®Hospital mortality—4 (3.7%) for all patientsNR
Standard of care
Luckraz 2003SternalV.A.C.®Mortality—4NR
V.A.C.® followed by a myocutaneous flap or primary wound closureMortality—7.7%
Treatment failure rate—15%
Doss 2002SternalV.A.C.®Mortality—1NR
Standard of careMortality—1NR
Vlayen et al. 2007 (180)Armstrong 2005DFUNPWTInfection—17%
Treatment related adverse events—12%
NR
Standard of careInfection—6%
Treatment related adverse events—13%
Joseph 2000Chronic non-healingNPWTInfection—0%NR
GauzeInfection—33%
Vuerstaek 2006Leg ulcersNPWTInfection—0%
Cutaneous damage secondary to therapy—23%
NR
Standard of careInfection—3%
Cutaneous damage secondary to therapy—7%
Braakenburg 2006Chronic and acuteNPWTDiscontinuation of treatment—2 patients due to pain during dressing changes or during NPWTNR
Various dressings 
Mendonca et al. 2006 (187)DeFranzo 2001Lower extremityNPWT3 cases of osteomyelitisNR
OHTAC 2006 (184)Armstrong 2005DFUNPWTInfection—13 (17%) 4 severeNR
Standard of careInfection—5 (6%) 2 were severe
Costa et al. 2005 (181)Song 2003SternalNPWTOsteomyelitis—1 (6%)
Calcaneal fractures—2 (11%)
NR
Standard of careOsteomyelitis—2 (11%)
Fistulas—2 (11%)
Wound infection—6 (33%)
Genecov 1998Skin graftsNPWTChronically draining wound—1 (7%)
Mediastinitis—1 (7%)
Omental flap losses—0
Intestinal evisceration—0
Hernia - 0
NR
OpSiteChronically draining wound—1 (6%)
Mediastinitis—1 (6%)
Omental flap losses—2 (12%)
Intestinal evisceration—1 (6%)
Hernia—1 (6%)
Argenta 1997MixedV.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)NRNPWTCalcaneal bone fractures—2
Osteomyelitis—1
NR
Topical treatment 
Fisher et Brady 2003 (SR)NRNPWTPain—induced from application of pressure or the intermittent pressure associated with sponge changes
Argenta 1997NRNPWTTissue erosion—around the egress tube when placed too close to a bony prominence or when excessive pressure is placed over the sponge dressingNR
Gwan-Nulla and Casal 2001*NRNPWTToxic shock syndrome—1NR
Chester and Waters 2002*NRNPWTBacteremia and sepsis—1NR
Standard of careNRNR
Samson et al. 2004 (182)Ford 2002Decubitus ulcersV.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 2000Chronic non-healingV.A.C.®3 of 18 V.A.C.® wounds developed complications including fistulas, wound infection, osteomyelitis, and calcaneal fracturesNR
Standard are8 of 18 wounds developed complications including fistulas, wound infection, osteomyelitis, and calcaneal fracturesNR

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