Results

Key Question 1: Does any single NPWT system have a significant therapeutic distinction in terms of wound healing outcomes compared to any other NPWT system for the treatment of acute or chronic wounds?

Based on our defined search strategies (go to Appendix A) and submissions from interested parties (Appendix D), no studies comparing one NPWT system to another NPWT system were identified that addressed this Key Question.

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Quantitative Synthesis of the Evidence Base

Due to the lack of studies that directly compared the efficacy and safety of one NPWT system to another NPWT system, we were unable to perform a quantitative synthesis to determine whether one system has any significant therapeutic distinction over another.

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Qualitative Synthesis of the Evidence Base

For the same reasons listed above for quantitative synthesis, no qualitative synthesis was possible.

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Was an indirect comparison possible?

Based on our pre-determined methodology, evidence for indirect comparisons was to be obtained from RCTs of commercially available NPWT systems versus a common comparator. Of 40 studies comparing a NPWT system to another wound care therapy, all were studies of the Kinetics Concepts Inc. (KCI) V.A.C.® system and only nine were RCTs. Therefore no indirect comparisons with other NPWT systems were possible.

In order to determine whether we could form evidence-based conclusions using methods of indirect comparison, we tabled important information from studies that compared NPWT to other wound therapies. Our systematic search of the literature, together with the submissions provided by manufacturers, identified 40 controlled studies comparing NPWT to other wound treatments. The material submitted by manufacturers contained two comparison studies involving NPWT systems that were not identified in our searches.(71,72) During the review process of the report, we also identified one additional comparison study of interest.(106) None of the submitted materials contained unpublished comparison studies with sufficient information to be included in this report. All of the identified studies evaluated the V.A.C.® Therapy system (KCI) in comparison to other wound therapies. Thus, we were unable to perform any indirect comparisons.

Despite the fact that we could not use the studies to answer the Key Question, we assessed the comparison studies for risk of bias and extracted data on treatment procedures, patient characteristics, wound types, comparator treatments, and study outcomes. We have provided tables with this information in Appendix C for the interested reader, and briefly discuss these studies here. The overall quality of the evidence base of 40 studies was considered low (significant potential for bias) based on a median quality score of 4.32 (go to Study Quality Assessment in Methods Section). None of the studies received a high-quality rating; seven (18%) were rated moderate, and 33 (82%) were rated low. Typical study limitations included lack of concealment of treatment allocation, lack of blinding patients and assessors, lack of reporting patient characteristics, and small study populations.

Blinding patients, treating physicians and outcome assessors to treatment increases the internal validity of intervention studies. In a situation where patients are being treated by NPWT systems, blinding the patient and the physician providing care is not feasible. To prevail over these limitations, van den Boogaard et al.(107) recommend overcoming all other potential shortcomings, i.e., wound assessors should be blinded to treatment, patient groups must be comparable, group allocation should be concealed, and full follow-up of a sufficient portion of all included patients should be performed.

None of the studies that we assessed reported that the physicians were blinded to treatment assignment, and only five (12%) of the studies reported blinding of outcome assessors. In only 7% of studies was there concealment of allocation to treatment. Only 14 (35%) studies had similar populations (i.e., wound size, wound severity and comorbidities), and 30% of the studies did not have similar follow-up times. Over 75% of the studies either reported a potential conflict of interest in terms of funding (k = 9) or made no report of their funding source (k = 22). Lastly, over 50% of the studies had a study size of fewer than 50 patients, in 85% of the studies there were fewer than 75 patients. Assessments of all included comparison studies can be found in Appendix B.

The seven moderate quality studies evaluated the use of the V.A.C.® system in the treatment of diabetic foot ulcers,(108,109) pressure ulcers,(110) chronic leg ulcers,(111) and wounds with mixed etiologies.(112-114) Two studies evaluated the use of the V.A.C.® system to secure split-thickness skin grafts.(112,115) Comparators included bolster dressings,(112) standard of care,(113) the Healthpoint System of topical gel products,(110) and advanced moist wound therapy (i.e., hydrogels, hydrocolloids, or alginates).(108,109,111,114) Primary endpoints included measures of wound reduction or time to complete wound healing.

Four studies concluded that the V.A.C.® system provided additional benefit when compared to other interventional treatments.(108,110,113,115) Vuerstaek et al.(115) evaluated 60 patients with chronic leg ulcers (venous, atherosclerotic, or mixed etiologies) randomized to treatment by V.A.C.® or alginate/hydrocolloids. Time to complete healing was significantly reduced in the V.A.C.® group: 29 days (95% CI: 25.5 to 32.5) versus 45 days (95% CI: 36.2 to 53.8). Results for secondary outcomes included a greater relapse at one-year followup (52% of all healed V.A.C.® ulcers relapsed compared with 42% in the control group). Both groups reported significant increases in quality of life and similar decreases in pain.

One moderate-quality study of 342 diabetic foot wounds,(108) reported a mean change in wound size in favor of the V.A.C.® system (-4.32 cm² versus -2.53 cm², p = 0.021), as well as a higher proportion of V.A.C.®-treated wounds achieving complete closure (43% vs. 28.9%). Data, however, were only reported for day 28 during the “active treatment phase,” whereas both three and nine month follow-up assessments were completed for patients achieving ulcer closure. This study reported the highest attrition rate (over 30%) of any controlled study; 40 patients (13% V.A.C.® due to adverse events).

Ford, et al. reported increased rates of pressure ulcer wound healing, superiority in decreasing inflammation at the wound site, and increased number of capillaries (suggesting the promotion of formation of granulation tissue) for the V.A.C.® system compared to the Healthpoint System (HP).(110) The HP system includes three gel products: Accuzyme (papain-urea debridement ointment), Iodosorb (0.9% cadexomer iodine) and Panafil (papain-urea, chlorophyllin, and copper ointment). However, in this interim report of the six-week study, complete wound healing was reported for only four wounds: two (10%) with V.A.C.® and two (13%) with the HP products. In a similar length study, Joseph et al.(113) studied 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. 24 cc), 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 in width, depth, and volume did not extrapolate to wound length (p = 0.38).

Three studies concluded a comparable benefit in comparisons of the V.A.C.® to control treatments.(109,112,114) Moisidis et al.(112) enrolled 22 patients (used as their own controls) with wounds clinically ready for skin graft. At two weeks, a quantitative assessment by a clinician blinded to treatment reported no significant difference in degree of epithelialization. A greater degree of epithelialization was reported in six cases (30%), the same degree in nine cases (45%), and less epithelialization in five cases (25%) of V.A.C.® versus control-treated wounds.

Armstrong et al.(109) reported results of a post hoc analysis of their 16-week study of 164 diabetic foot amputation wounds. Results for this evaluation of the impact of wound chronicity indicated no significant difference for proportion of acute (<30 days, 75% of study patients) and chronic (>30 days, 25% of the study population) wounds achieving complete wound closure (acute p = 0.072, chronic p = 0.320) between NPWT and control groups. However, the authors found improved time to complete healing with NPWT compared to control treatments for both acute and chronic wounds.

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 days (V.A.C.® vs. 20 days [control]) and overall change in the amount of granulation.

For further information on comparison studies evaluating V.A.C.® to other treatments for acute and chronic wounds, please go to Appendix C.

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Key Question 2: Does any component of a NPWT system have a significant therapeutic distinction compared to any other similar component of a NPWT system for the treatment of acute or chronic wounds?

Our searches did not identify any studies comparing one NPWT system component to another NPWT system component (with both groups receiving negative pressure treatment) that addressed this Key Question. No published on unpublished studies of this design were submitted by interested parties. This question was designed to examine studies that compared different dressing sets, tubing, or pumps while maintaining identical components for the other parts of an NPWT system.

We did identify one study that compared the V.A.C.® Therapy system (KCI) to an alternative form of negative pressure using vacuum bottles while using the same foam dressing set. This study is briefly described here.(116)

In this study, Wild, et al. randomized ten patients with Grade III and Grade IV pressure ulcers to the V.A.C.® Therapy system (KCI) or the Redon drain/vacuum group (P.J. Dahlhausen & Co. GmbH, Cologne, Germany). All patients were treated with the same GranuFoam®(KCI) dressings. V.A.C.®-treated wounds received negative pressure (-125 mmHg) therapy by a computerized controlled therapy unit. A typical maximum treatment pressure for the NPWT devices currently cleared for marketing in the U.S. is 200 mmHg. Wounds in the control group received uncontrolled negative pressure (-900 mmHg) by a non-powered Redon vacuum bottle.

Primary endpoints for the study included absolute and relative proportion of the wound area consisting of granulation tissue, fibrin deposits and necrosis. Results indicated that V.A.C.® was more effective than the Redon vacuum bottles in terms of change in surface granulation tissue (increase of 54% versus decrease of 7.1%, control; p = 0.001), presence of necrotic tissue (0.3% versus >10%, control), and change in fibrin tissue (decrease of 27% versus increase of 21.8%, control; p = 0.035) (Table 8).

The study was terminated at day nine due to the large disparity in outcomes between treatment groups, and the added care needed for the Redon group (Table 9). The authors concluded that the non-powered vacuum bottle approach to applying negative pressure to a pressure ulcer was not appropriate.

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Key Question 3: What are the reported occurrences of pain, bleeding, infection, other complications, and mortality for NPWT systems?

Adverse events were reported in 37 of 40 (92%) studies comparing NPWT to other treatments. Of the 37 studies reporting events, seven (19%) studies described NPWT as a safe treatment. Fewer complications were reported in the NPWT-treated patients than in those receiving other wound therapies in 19 (51%) studies(1,23,71,72,106,108,110,113,114,117-126) and similar complications were reported in 8 (23%) studies.(109,127-133) Most commonly reported adverse events included pain (k = 8), bleeding (k = 6), infection (k = 13), mortality (k = 10), and other complications (k = 17). Reports were similar for bleeding, infection, amputation, and other complications (i.e, fistulae). However, fewer secondary amputations (7 versus 17) were reported in NPWT groups (all studies reported using V.A.C.® system). Reports of adverse events for comparison studies can be found in the tables that follow.

Reports of adverse events described in systematic reviews can be found in Table 42 in Appendix C.

Table 5. Reports of Pain in Comparison Studies of NPWT Devices

Reference	Wound Type	Treatment	Number of Patient Reports (n)
Bickels et al.(134)	Soft tissue defects	V.A.C.®	No patients experienced substantial pain
	Soft tissue defects	SOC	No patients experienced substantial pain
Braakenburg, et al.(114)	Acute and chronic	V.A.C.®	2 patients discontinued treatment due to pain during dressing change
	Acute and chronic	Conventional	NR
Denzinger et al.(135)	Complex inguinal	V.A.C.®	Not specifically quantified, however patients reported more pain with dressing change in V.A.C.® group
	Complex inguinal	SOC	Less pain reported than V.A.C.® group
Genecov, et al.(131)	STSG	V.A.C.®	No difference in pain
	STSG	Control	No difference in pain
McCallon, et al.(120)	DFU	V.A.C.®	Due to initial foam collapse and/or with foam removal; Number of patients NR
	DFU	Saline-moistened gauze	NR
Moues et al.(136)	Full-thickness	V.A.C.®	1 patient discontinued treatment due to ischaemic pain with increased tissue necrosis
	Full-thickness	Standard moist gauze	NR
Ozturk et al.(117)	Fournier's gangrene	V.A.C.®	Patients reported less pain when measured by Visual Analogue Scale (0-10, with higher numbers indicating more pain) Mean V.A.S. score: 2.4
	Fournier's gangrene	SOC	Mean V.A.S. score: 6.8
Vuerstaek, et al.(115)	Chronic leg ulcers	V.A.C.®	3 complaints of pain reported as adverse events; mean pain scores decreased over time
	Chronic leg ulcers	Control	1 complaint of pain reported as adverse event; mean pain scores decreased over time

DFU   Diabetic foot ulcer
NR   Not reported
SOC   Standard of care
STSG   Split thickness skin graft
V.A.S.   Visual analogue scale for pain

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Table 6. Reports of Bleeding in Comparison Studies of NPWT Devices

Reference	Wound Type	Treatment	Number of Patient Reports (n)
McCallon, et al.(120)	DFU	V.A.C.®	Granulation tissue growth into pores of the foam frequently resulted in minor capillary disruption upon V.A.C.® foam dressing removal.
	DFU	SOC	NR
Simek, et al.(123)	Deep sternal	V.A.C.®	Intractable: 2.9%
	Deep sternal	Conventional	Intractable: 3.6%
Segers, et al.(122)	PM	V.A.C.®	4
	PM	Closed drainage	4
Fuchs et al.(123)	Deep sternal	V.A.C.®	NR
	Deep sternal	Conventional	2 deaths due to bleeding
Bickels, et al.(134)	Soft tissue	V.A.C.®	No patients had excessive bleeding
	Soft tissue	SOC	No patients had excessive bleeding
Vuerstaek, et al.(115)	Chronic leg	V.A.C.®	0
	Chronic leg	Conventional (hyrocolloids, alginates)	2

NR   Not reported

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Table 7. Reports of Infection in Comparison Studies of NPWT Devices

Reference	Wound Type	Treatment	Number of Patient Reports (n)
Armstrong, et al.(109)	Diabetic foot amputation	V.A.C.®	NR
	Diabetic foot amputation	SWT	2
Blume, et al.(108)	DFU	V.A.C.®	Wound infection: 4 Cellulitis: 4 Osteomyelitis: 1 Staphylococcus: 1 Infected skin ulcer: 1
	DFU	AMWT	Wound infection: 1 Cellulitis: 1 Infected skin ulcer: 2
Ford, et al.(110)	Pressure ulcer	V.A.C.®	Osteomyelitis confirmed in 13 wounds (treatment not confirmed)
	Pressure ulcer	Healthpoint System	Osteomyelitis confirmed in 13 wounds (treatment not confirmed)
Joseph, et al.(113)	Pressure ulcer	V.A.C.®	Osteomyelitis - 1
	Pressure ulcer	Saline wet-to-moist	Osteomyelitis - 2 Wound infection - 6
Labler, et al.(71)	Soft tissue	V.A.C.®	Infections resulting in non-union: 2 Infections: 1
	Soft tissue	Epigard® dressing	Infections resulting in non-union: 2
Moues, et al.(136)	Full-thickness	V.A.C.®	4
	Full-thickness	V.A.C.®	4
Rinker, et al.(121)	Open tibia fracture	V.A.C.®	6% infectious complications
	Open tibia fracture	SOC	18% infectious complications
Song, et al.(124)	Surgical	V.A.C.®	Mediastinitis - 1
	Surgical	SOC	Recurrent mediastinitis - 1
Segers, et al.(122)	PM	V.A.C.®	Mortality caused by surgical site infection: 4 (13.8%)
	PM	Closed drainage	Mortality caused by surgical site infection: 7 (20.6%)
Stannard, et al.(125)	Hematoma	V.A.C.®	NR
	Hematoma	Pressure dressing	1 - late infection at site of hematoma
	Fracture	V.A.C.®	3
	Fracture	Post-operative dressing	3
Timmers, et al.(106)	Post-traumatic osteomyelitis	NPIT	Recurrence of osteomyelitis - 3 (10%)
	Post-traumatic osteomyelitis	SOC	Recurrence of osteomyelitis - 55 (58.5%)
Vuerstaek, et al.(115)	Chronic leg	V.A.C.®	0
	Chronic leg	Conventional (hyrocolloids, alginates)	1
Yang, et al.(72)	Fasciotomy	V.A.C.®	None
	Fasciotomy	Saline wet-to-moist	Wound Infection - 1

AMWT   Advanced moist wound therapy
DFU   Diabetic foot ulcer
NPIT   Negative pressure instillation therapy
NR   Not reported
PM   Post-sternotomy mediastinitis
SOC   Standard of care
SWT   Standard wound therapy

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Table 8. Reports of Mortality in Comparison Studies of NPWT Devices

Reference	Wound Type	Treatment	Number of Patient Reports (n)
Blume, et al.(108)	DFU	V.A.C.®	3
	DFU	AMWT	3
Braakenburg, et al.(114)	Chronic and acute	V.A.C.®	3
	Chronic and acute	Hydrocolloid dressings, alginate, acetic acid or Eusol (sodium hypochlorite)	5
Catarino, et al.(137)	Post-sternotomy mediastinitis	V.A.C.®	Due to pneumonia 5 months postoperative: 1
	Post-sternotomy mediastinitis	Closed drainage and irrigation	0
Doss, et al.(128)	Post-sternotomy osteomyelitis	V.A.C.®	Hospital mortality: 1
	Post-sternotomy osteomyelitis	SOC	Hospital mortality: 1
Fuchs, et al.(23)	Deep sternal	V.A.C.®	Death due to vacuum-related perforation: 1
	Deep sternal	Conventional	Death due to bleeding: 2 Death due to septic shock: 2
Huang, et al.(127)	Limb	V.A.C.®	1
	Limb	SOC	1
Immer, et al.(130)	Deep sternal wound infection	V.A.C.®	Multiorgan failure: 1
	Deep sternal wound infection	V.A.C.® plus excision plus musculocutaneous flap	NR
	Deep sternal wound infection	Excision plus musculocutaneous flap	Multiorgan failure: 1 Uncontrollable septicemia: 1
Segers, et al.(122)	PM	V.A.C.®	9
	PM	Closed drainage	9
Song, et al.(124)	Surgical	V.A.C.®	Death from aspiration pneumonia: 2 Death from multisystem organ failure: 1
	Surgical	SOC	Death from aspiration pneumonia: 1
Vuerstaek, et al.(115)	Chronic leg	V.A.C.®	4
	Chronic leg	V.A.C.®	4

AMWT   Advanced moist wound therapy
DFU   Diabetic foot ulcer
NR   Not reported
SOC   Standard of care

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Table 9. Reports of Other Complications in Comparison Studies of NPWT Devices

Reference	Wound Type	Treatment	Number of Patient Reports (n)
Armstrong, et al.(109)	Diabetic foot amputation	V.A.C.®	Serious complication: 1
	Diabetic foot amputation	SWT	NR
Blume, et al.(108)	DFU	V.A.C.®	Secondary amputations: 7 Edema: 5
	DFU	AMWT	Secondary amputations: 17 Edema: 7
Braakenburg, et al.(114)	Acute and chronic	V.A.C.®	Early dismissal: 2 Refusal to cooperate: 1
	Acute and chronic	Conventional	Amputation: 1 Early dismissal: 6
Domkowski, et al.(129)	Post-sternotomy mediastinitis	V.A.C.®	Multisystem organ failure: 2 Overwhelming sepsis: 2
	Post-sternotomy mediastinitis	Standard of care	NR
Huang, et al.(127)	Limb	V.A.C.®	Above-knee amputation: 1 Below-knee amputation: 1
	Limb	SOC	Above-knee amputation: 2
Joseph, et al.(113)	Pressure ulcer	V.A.C.®	Calcaneal fracture: 2 Amputation: 2
	Pressure ulcer	Saline wet-to-moist	Fistulae: 2
Labler, et al.(71)	Soft tissue	V.A.C.®	Amputation: 1
	Soft tissue Epigard® dressing	Amputation: 2 (1 patient died 2 days later due to cardiovascular instability)	Non-union without infection: 1
Moisidis, et al.(112)	Clinically ready for skin graft	V.A.C.®	Difficulty in maintaining pressure: 3
	Clinically ready for skin graft	Bolster dressing	NR
Moues, et al.(136)	Full thickness	V.A.C.®	Erosion of adjacent tissue due to increased local pressure: 1 Maceration/eczema: 2 Sudden increase in body temperature: 1 Postoperative complications after surgical closure: 32% Most notable postoperative complications: Abscess: 2 Fistula: 1 Total skin graft failure: 1
	Full thickness	Standard moist gauze	Allergic reaction to Furacine®: 2 Wound surface area increase: 3 Postoperative complications after surgical closure: 43% Most serious postoperative complications: Abscess: 1 Fistula: 1 Skin graft failure of 40%: 1
Rinker, et al.(121)	Open tibia fracture	V.A.C.®	Overall complication rate: 35% Flap related complications: 12% Amputation: 1 (6%)
	Open tibia fracture	SOC	Overall complication rate: 53% Flap related complications: 21% Amputation: 2 (5%)
Schwein, et al.(126)	Pressure Ulcer	V.A.C.®	Hospitalization for a wound-related problem: 3 (5%)
	Pressure Ulcer	Any other wound care modality	Hospitalization for a wound-related problem: 310 (14%)
Shilt, et al.(138)	Traumatic	V.A.C.®	Patients requiring home nursing after discharge: 4
	Traumatic	Standard of care	NR
Siegel, et al.(119)	Radiation-associated	V.A.C.®	Amputation: 1 Mild discomfort: 3 Skin rash: 2 Itching: 3
	Radiation-associated	SOC	Above-knee amputation: 3 Hip disarticulation: 1
Simek, et al.(123)	Deep sternal	V.A.C.®	Fistula: 14.7%
	Deep sternal	Conventional	Fistula: 10.7%
Sjogren, et al.(139)	Post-sternotomy mediastinitis	V.A.C.®	Recurrent sternal fistulae: 4 (6.6%)
	Post-sternotomy mediastinitis	Conventional	Recurrent sternal fistulae: 2 (5%)
Song, et al.(124)	Surgical	V.A.C.®	Chronically draining wound: 1
	Surgical	SOC	Chronically draining wound: 1 Omental flap losses: 2 Intestinal evisceration: 1 Hernia: 1
Stannard, et al.(125)	Hematoma	V.A.C.®	NR
	Hematoma	Pressure dressing	NR
	Fracture	V.A.C.®	Delayed wound breakdown: 1
	Fracture	Post-operative dressing	Delayed wound breakdown: 1

AMWT   Advanced moist wound therapy
DFU   Diabetic foot ulcer
SOC   Standard of care
SWT   Standard wound therapy

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For additional information on adverse events we identified 103 case series (studies with no control group) of NPWT. Twenty-four of these studies had not been identified in our literature searches. Studies included chronic wounds (k = 48), acute wounds (k = 35) or mixed wounds (e.g., chronic and acute) (k = 20). We prepared four tables that summarize the data reported in these studies: patient characteristics, treatment details, outcomes reported, and adverse events (Go to Appendix C). The tables are organized by year (the most recent is first) and then by author, alphabetically. Ninety-five studies specified using the vacuum-assisted closure device manufactured by KCI.

The adverse events reported in these studies include pain (k = 12);(78,88,91,140-148) bleeding (k = 7);(79,142,147,149-152) infection or bacterial colonization (k = 15);(37,77,85,86,96,148-150,153-159) mortality (k = 4);(149-151,153) and other complications (k = 18).(95)

Table 10 lists the 18 studies that mentioned other complications, such as fistulae and skin blisters. Case series may report adverse events inconsistently. Some case series report all adverse events, while others report events the authors consider "serious." If a study does not report a particular adverse event it still may have occurred unless the publication specifically states that the specific adverse event did not occur. Based on the inconsistencies of reporting for case series, we have not pooled the results to determine a rate of adverse event occurrence.

Table 10. Other Complications Reported in Case Studies

Reference	Other Complications
Chen, et al. 2008 (160)	Right ventricular rupture while a patient was being treated with vacuum assisted closure dressing. The patient coughed excessively during early postoperative period, possibly resulting in sternal shear force being applied directly over the right ventricular wall.1
Ha, et al. 2008 (140)	Dryness, sloughy wounds, and excoriation as reasons for discontinuing the use of the vacuum assisted closure therapy.1
Wondberg, et al. 2008 (161)	Fistulae, fascial edge necroses, skin blister, prolapses of small bowel between fascia and foam.1
Baharestani, et al. 2007 (162)	Development of an enterocutaneous fistula during vacuum assisted closure therapy.1
Bendewald, et al. 2007 (82)	Significant skin irritation from the negative pressure wound therapy dressing material.1
McCord, et al. 2007 (142)	Dermatitis or skin maceration from adhesive dressing.1
Rao, et al. 2007 (163)	Intestinal fistulation during vacuum-assisted closure therapy.1
Morgan, et al. 2006 (164)	Flap failure in a patient treated with vacuum-assisted closure therapy.1 The system was set at 125 mmHg; authors stated that this pressure was probably too high for a flap.
Butter, et al. 2005 (144)	Failure of wound closure after use of vacuum-assisted closure therapy and recurrent pilonidal sinuses.
Caniano, et al. 2005 (165)	Retained sponge and device malfunction.1
Heller, et al. 2005 (87)	Low-output small bowel enterocutaneous fistula.1
Perez, et al. 2007 (95)	High-output enterocutaneous fistula.1
Stone, et al. 2004 (90)	Abdominal abscesses and enterocutaneous fistula.1
Gustafsson, et al. 2003 (146)	Minor air leakage requiring complementary draping.1
Suliburk, et al. 2003 (166)	Vacuum assisted closure therapy1 was discontinued as a result of fistulae that developed or as a result of poor fascia.
Armstrong, et al. 2002 (85)	Periwound maceration, periwound cellulitis, and deep space infection.1
De Lange, et al. 2000 (167)	Retention development, some developed septicemia, fistulae, local necrosis, chest wall dehiscence possibly caused by local air leakage.1
Argenta and Morykwas 1997 (148)	Fistula development when a foam dressing was placed directly over compromised intestine in a debilitated patient who had eviscerated.1

¹  Device manufactured by KCI

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Key Question 4: Do patients being treated with one NPWT system have a significant therapeutic distinction in terms of less pain, bleeding, infection, other complications, or mortality than other NPWT systems?

Our searches, as well as material provided by interested parties, did not identify any studies comparing one NPWT system to another NPWT system. Consequently, we were not able to answer this Key Question and we were not able to determine the severity of adverse events for one NPWT system compared to another.

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