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. 2022 Apr 26;4(4):CD009261.
doi: 10.1002/14651858.CD009261.pub7.

Negative pressure wound therapy for surgical wounds healing by primary closure

Gill Norman  1 , Chunhu Shi  1 , En Lin Goh  2 , Elizabeth Ma Murphy  3 , Adam Reid  4 , Laura Chiverton  5 , Monica Stankiewicz  6 , Jo C Dumville  1
Affiliations

Negative pressure wound therapy for surgical wounds healing by primary closure

Gill Norman et al. Cochrane Database Syst Rev. .

Abstract

Background: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). Existing evidence for the effectiveness of NPWT on postoperative wounds healing by primary closure remains uncertain.

Objectives: To assess the effects of NPWT for preventing SSI in wounds healing through primary closure, and to assess the cost-effectiveness of NPWT in wounds healing through primary closure.

Search methods: In January 2021, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries and references of included studies, systematic reviews and health technology reports. There were no restrictions on language, publication date or study setting.

Selection criteria: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another.

Data collection and analysis: At least two review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, assessment using the Cochrane risk of bias tool, and quality assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. Our primary outcomes were SSI, mortality, and wound dehiscence.

Main results: In this fourth update, we added 18 new randomised controlled trials (RCTs) and one new economic study, resulting in a total of 62 RCTs (13,340 included participants) and six economic studies. Studies evaluated NPWT in a wide range of surgeries, including orthopaedic, obstetric, vascular and general procedures. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain. Primary outcomes Eleven studies (6384 participants) which reported mortality were pooled. There is low-certainty evidence showing there may be a reduced risk of death after surgery for people treated with NPWT (0.84%) compared with standard dressings (1.17%) but there is uncertainty around this as confidence intervals include risk of benefits and harm; risk ratio (RR) 0.78 (95% CI 0.47 to 1.30; I2 = 0%). Fifty-four studies reported SSI; 44 studies (11,403 participants) were pooled. There is moderate-certainty evidence that NPWT probably results in fewer SSIs (8.7% of participants) than treatment with standard dressings (11.75%) after surgery; RR 0.73 (95% CI 0.63 to 0.85; I2 = 29%). Thirty studies reported wound dehiscence; 23 studies (8724 participants) were pooled. There is moderate-certainty evidence that there is probably little or no difference in dehiscence between people treated with NPWT (6.62%) and those treated with standard dressing (6.97%), although there is imprecision around the estimate that includes risk of benefit and harms; RR 0.97 (95% CI 0.82 to 1.16; I2 = 4%). Evidence was downgraded for imprecision, risk of bias, or a combination of these. Secondary outcomes There is low-certainty evidence for the outcomes of reoperation and seroma; in each case, confidence intervals included both benefit and harm. There may be a reduced risk of reoperation favouring the standard dressing arm, but this was imprecise: RR 1.13 (95% CI 0.91 to 1.41; I2 = 2%; 18 trials; 6272 participants). There may be a reduced risk of seroma for people treated with NPWT but this is imprecise: the RR was 0.82 (95% CI 0.65 to 1.05; I2 = 0%; 15 trials; 5436 participants). For skin blisters, there is low-certainty evidence that people treated with NPWT may be more likely to develop skin blisters compared with those treated with standard dressing (RR 3.55; 95% CI 1.43 to 8.77; I2 = 74%; 11 trials; 5015 participants). The effect of NPWT on haematoma is uncertain (RR 0.79; 95 % CI 0.48 to 1.30; I2 = 0%; 17 trials; 5909 participants; very low-certainty evidence). There is low-certainty evidence of little to no difference in reported pain between groups. Pain was measured in different ways and most studies could not be pooled; this GRADE assessment is based on all fourteen trials reporting pain; the pooled RR for the proportion of participants who experienced pain was 1.52 (95% CI 0.20, 11.31; I2 = 34%; two studies; 632 participants). Cost-effectiveness Six economic studies, based wholly or partially on trials in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in five indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty; coronary artery bypass grafts; and vascular surgery with inguinal incisions. They calculated quality-adjusted life-years or an equivalent, and produced estimates of the treatments' relative cost-effectiveness. The reporting quality was good but the evidence certainty varied from moderate to very low. There is moderate-certainty evidence that NPWT in surgery for lower limb fracture was not cost-effective at any threshold of willingness-to-pay and that NPWT is probably cost-effective in obese women undergoing caesarean section. Other studies found low or very low-certainty evidence indicating that NPWT may be cost-effective for the indications assessed.

Authors' conclusions: People with primary closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSIs than people treated with standard dressings but there is probably no difference in wound dehiscence (moderate-certainty evidence). There may be a reduced risk of death after surgery for people treated with NPWT compared with standard dressings but there is uncertainty around this as confidence intervals include risk of benefit and harm (low-certainty evidence). People treated with NPWT may experience more instances of skin blistering compared with standard dressing treatment (low-certainty evidence). There are no clear differences in other secondary outcomes where most evidence is low or very low-certainty. Assessments of cost-effectiveness of NPWT produced differing results in different indications. There is a large number of ongoing studies, the results of which may change the findings of this review. Decisions about use of NPWT should take into account surgical indication and setting and consider evidence for all outcomes.

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Conflict of interest statement

Gill Norman: I am partially funded by the National Institute for Health Research Applied Research Collaboration Greater Manchester. My employment at the University of Manchester is partially funded by the National Institute for Health Research through Cochrane Wounds. My work on previous versions of this review was also supported by the NIHR Manchester Biomedical Research Centre. I am an Editor for Cochrane Wounds and was not involved in the editorial process for this review.

Chunhu Shi: none known

En Lin Goh: none known

Elizabeth Murphy: I work as a healthcare professional. Work on this review was supported by an internship funded by the National Institute for Health Research Applied Research Collaboration Greater Manchester and the NIHR Manchester Biomedical Research Centre.

Adam Reid: I work as a healthcare professional.

Monica Stankiewicz: I work as an independent consultant for Griffith Health Institute, Griffith University.

Laura Chiverton: my work on this review was supported by the NIHR Manchester Biomedical Research Centre.

Jo Dumville: I received research funding from the NIHR for the production of systematic reviews focusing on high‐priority Cochrane reviews in the prevention and treatment of wounds. This research was co‐funded by the NIHR Manchester Biomedical Research Centre and partly funded by the National Institute for Health Applied Research Collaboration Greater Manchester. I am a joint Co‐ordinating Editor of Cochrane Wounds and was not involved in the editorial process for this review.

Ljubiša Paden (peer reviewer): I received a conference speaker fee from medical device distributor Zaloker&Zaloker d.o.o. The company has confirmed that it does not distribute Negative Pressure Wound Therapy devices.

Figures

1
1
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
2
2
Study flow diagram
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
4
4
Funnel plot of comparison: 1 Negative pressure wound therapy versus standard dressing, outcome: 1.2 Surgical site infection
1.1
1.1. Analysis
Comparison 1: Negative pressure wound therapy versus standard dressing, Outcome 1: Mortality
1.2
1.2. Analysis
Comparison 1: Negative pressure wound therapy versus standard dressing, Outcome 2: Surgical site infection
1.3
1.3. Analysis
Comparison 1: Negative pressure wound therapy versus standard dressing, Outcome 3: SSI grouped by contamination class
1.4
1.4. Analysis
Comparison 1: Negative pressure wound therapy versus standard dressing, Outcome 4: SSI (superficial)
1.5
1.5. Analysis
Comparison 1: Negative pressure wound therapy versus standard dressing, Outcome 5: SSI (deep)
1.6
1.6. Analysis
Comparison 1: Negative pressure wound therapy versus standard dressing, Outcome 6: Dehiscence
1.7
1.7. Analysis
Comparison 1: Negative pressure wound therapy versus standard dressing, Outcome 7: Reoperation
1.8
1.8. Analysis
Comparison 1: Negative pressure wound therapy versus standard dressing, Outcome 8: Readmission
1.9
1.9. Analysis
Comparison 1: Negative pressure wound therapy versus standard dressing, Outcome 9: Seroma
1.10
1.10. Analysis
Comparison 1: Negative pressure wound therapy versus standard dressing, Outcome 10: Haematoma
1.11
1.11. Analysis
Comparison 1: Negative pressure wound therapy versus standard dressing, Outcome 11: Skin blisters
1.12
1.12. Analysis
Comparison 1: Negative pressure wound therapy versus standard dressing, Outcome 12: Pain
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References

References to studies included in this review

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    1. Newman JM, Siqueira MB, Klika AK, Molloy RM, Barsoum WK, Higuera CA.Use of closed incisional negative pressure wound therapy after revision total hip and knee arthroplasty in patients at high risk for infection: a prospective, randomized clinical trial. Journal of Arthroplasty 2019;34(3):554-9. - PubMed
Nherera 2017 {published data only}
    1. Nherera LM, Trueman P, Karlakki SL.Cost-effectiveness analysis of single-use negative pressure wound therapy dressings (sNPWT) to reduce surgical site complications (SSC) in routine primary hip and knee replacements. Wound Repair and Regeneration 2017;25(3):474-82. - PubMed
Nherera 2018 {published data only}
    1. Nherera LM, Trueman P, Schmoeckel M, Fatoye FA.Cost-effectiveness analysis of single use negative pressure wound therapy dressings (sNPWT) compared to standard of care in reducing surgical site complications (SSC) in patients undergoing coronary artery bypass grafting surgery. Journal of Cardiothoracic Surgery 2018;13(1):103. - PMC - PubMed
Nordmeyer 2016 {published data only}
    1. Nordmeyer M, Pauser J, Biber R, Jantsch J, Lehrl S, Kopschina C, et al.Negative pressure wound therapy for seroma prevention and surgical incision treatment in spinal fracture care. International Wound Journal 2016;13(6):1176-9. - PMC - PubMed
O'Leary 2017 {published data only}
    1. Carter MR, Burton M, Anglim B, Concannon E, Pierce C, Coffee SN, et al.A randomised controlled trial of negative pressure wound therapy at primary closure of midline laparotomy wounds. Irish Journal of Medical Science 2016;185:S111.
    1. O'Leary DP, Peirce C, Anglim B, Carter M, Hickey K, Coffey JC.Prophylactic negative pressure dressing use in closed laparotomy wounds following abdominal operations: a randomized, controlled, open-label trial: the P.I.C.O. trial. Annals of Surgery 2017;265(6):1082-6. - PubMed
Pachowsky 2012 {published data only}
    1. Pachowsky M, Gusinde J, Klein A, Lehrl S, Schulz-Drost S, Schlechtweg P, et al.Negative pressure wound therapy to prevent seromas and treat surgical incisions after total hip arthroplasty. International Orthopaedics 2012;36(4):719-22. - PMC - PubMed
Pauser 2016 {published data only}
    1. Pauser J, Nordmeyer M, Biber R, Jantsch J, Kopschina C, Bail HJ.Incisional negative pressure wound therapy after hemiarthroplasty for femoral neck fractures - reduction of wound complications. International Wound Journal 2016;13(5):663-7. - PMC - PubMed
Pleger 2018 {published data only}
    1. Pleger SP, Nink N, Elzien M, Kunold A, Koshty A, Böning A.Reduction of groin wound complications in vascular surgery patients using closed incision negative pressure therapy (ciNPT): a prospective, randomised, single-institution study. International Wound Journal 2018;15(1):75-83. - PMC - PubMed
Ruhstaller 2017 {published data only}
    1. Ruhstaller K, Downes K, Chandrasekaren S, Elovitz MA, Srinivas S, Durnwald C.PROphylactic wound VACuum therapy after cesarean section to prevent wound complications in the obese population: a randomised controlled trial (the PROVAC study). American Journal of Obstetrics and Gynecology 2017;216(1 Suppl 1):S34. - PMC - PubMed
    1. Ruhstaller K, Downes KL, Chandrasekaran S, Srinivas S, Durnwald C.Prophylactic wound vacuum therapy after cesarean section to prevent wound complications in the obese population: a randomized controlled trial (the ProVac study). American Journal of Perinatology 2017;34(11):1125. - PMC - PubMed
Sabat 2016 {published data only}
    1. Sabat J, Tyagi S, Srouji A, Pechman D, Gupta AM, Lucido D, et al.Prophylactic negative pressure therapy for femoral incision in vascular surgery: preliminary results of a prospective randomised trial. Journal of Vascular Surgery 2016;63:94S.
Schmid 2018 {published data only}
    1. Schmid S, Seitz A, Haller B, Fritsche H, Huber T, Burger M, et al.Results of the first interim analysis of the PräVAC trial: prevention of wound complications following inguinal lymph node dissection in patients with penile cancer using epidermal vacuum-assisted wound closure. European Urology 2018;17(2 Suppl):e51. - PMC - PubMed
    1. Schmid SC, Seitz AK, Haller B, Fritsche H-M, Huber T, Burger M, et al.Final results of the PräVAC trial: prevention of wound complications following inguinal lymph node dissection in patients with penile cancer using epidermal vacuum-assisted wound closure. World Journal of Urology 2021;39(2):613-20. - PMC - PubMed
Shen 2017 {published data only}
    1. Shen P, Blackham AU, Lewis S, Clark CJ, Howerton R, Mogal HD, et al.Phase II randomized trial of negative-pressure wound therapy to decrease surgical site infection in patients undergoing laparotomy for gastrointestinal, pancreatic, and peritoneal surface malignancies. Journal of the American College of Surgeons 2017;224(4):726-37. - PMC - PubMed
Shim 2018 {published data only}
    1. Shim HS, Choi JS, Kim SW.A role for postoperative negative pressure wound therapy in multitissue hand injuries. Biomed Research International 2018;2018(4):1-7. - PMC - PubMed
Stannard 2012 {published data only}
    1. Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, et al.Incisional negative pressure wound therapy after high-risk lower extremity fractures. Journal of Orthopaedic Trauma 2012;26(1):37-42. - PubMed
Svensson‐Bjork 2020 {published data only}
    1. Svensson-Bjork R, Saha S, Acosta S, Gerdtham UG, Hasselmann J, Asciutto G, et al.Cost-effectiveness analysis of negative pressure wound therapy dressings after open inguinal vascular surgery - the randomised INVIPS-Trial. Journal of Tissue Viability 2020;30:30. - PubMed
Tanaydin 2018 {published data only}
    1. Holford NC.Negative-pressure wound therapy - does it lower the risk of complications with closed wounds following breast surgery? Expert Review of Medical Devices 2020;17(10):1017-9. - PubMed
    1. Tanaydin V, Beugels J, Andriessen A, Sawor JH, Van der Hulst RR.Randomized controlled study comparing disposable negative-pressure wound therapy with standard care in bilateral breast reduction mammoplasty evaluating surgical site complications and scar quality. Aesthetic Plastic Surgery 2018;42(4):927-35. [DOI: 10.1007/s00266-018-1095-0] - DOI - PMC - PubMed
    1. Tanaydin V, Beugels J, Andriessen A, Sawor JH, Van der Hulst RR.Randomized controlled study comparing disposable negative-pressure wound therapy with standard care in bilateral breast reduction mammoplasty evaluating surgical site complications and scar quality. Aesthetic Plastic Surgery 2018;42(4):Erratum in: Aesthetic Plastic Surgery 2018; 42 (4):1176. - PMC - PubMed
Tuuli 2017 {published data only}
    1. Tuuli MG, Martin S, Stout MJ, Steiner HL, Harper LM, Longo S, et al.Pilot randomized trial of prophylactic negative pressure wound therapy in obese women after cesarean delivery. American Journal of Obstetrics and Gynecology 2017;216(1 Suppl 1):S245.
Tuuli 2020 {published data only}
    1. Tuuli MG, Liu J, Tita AT, Longo S, Trudell A, Carter EB, et al.Effect of prophylactic negative pressure wound therapy vs standard wound dressing on surgical-site infection in obese women after cesarean delivery: a randomized clinical trial. JAMA 2020;324(12):1180-9. - PMC - PubMed
Uchino 2016 {published data only}
    1. Uchino M, Hirose K, Bano T, Chohno T, Takesue Y, Ikeuchi H.Randomized controlled trial of prophylactic negative-pressure wound therapy at ostomy closure for the prevention of delayed wound healing and surgical site infection in patients with ulcerative colitis. Digestive Surgery 2016;33(6):449-54. - PubMed
WHIST 2019a {published data only}
    1. Achten J, Vadher K, Bruce J, Nanchahal J, Spoors L, Masters JP, et al.Standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for major trauma to the lower limb - a two-arm parallel group superiority randomised controlled trial: protocol for wound healing in surgery for trauma (WHIST). BMJ Open 2018;8(6):e022115. - PMC - PubMed
    1. Campolier M, Knight R, Spoors L, Achten J, Costa M.Assessing the quality of data collection in clinic; lessons from the wound healing in surgical trauma (WHiST) RCT. Trials 2019;20(Supp 1):P-34.
    1. Costa ML, Achten J, Knight R, Bruce J, Dutton SJ, Madan J, et al.Effect of incisional negative pressure wound therapy vs standard wound dressing on deep surgical site infection after surgery for lower limb fractures associated with major trauma. The WHIST randomized clinical trial. JAMA 2020;323(6):519-26. - PMC - PubMed
    1. Costa ML, Achten J, Knight R, Png ME, Bruce J, Dutton S, et al.Negative-pressure wound therapy compared with standard dressings following surgical treatment of major trauma to the lower limb: the WHiST RCT. Health Technology Assessment 2020;24(38):1-86. - PMC - PubMed
    1. Knight R, Spoors LM, Costa ML, Dutton SJ.Wound healing in surgery for trauma (WHIST): statistical analysis plan for a randomised controlled trial comparing standard wound management with negative pressure wound therapy. Trials 2019;20(1):186. - PMC - PubMed
WHIST 2019b {published data only}
    1. Costa ML, Achten J, Knight R, Png ME, Bruce J, Dutton S, et al.Standard wound management versus negative pressure wound therapy following surgical treatment of major trauma to the lower limb: the WHiST randomised controlled trial. HTA Monograph 2020;24(38):1-86. - PMC - PubMed
    1. Png ME, Madan JJ, Dritsaki M, Achten J, Parsons N, Fernandez M, et al.Cost-utility analysis of standard dressing compared with incisional negative-pressure wound therapy among patients with closed surgical wounds following major trauma to the lower limb. Bone and Joint Journal 2020;102(8):1072-81. - PubMed
Wierdak 2021 {published data only}
    1. Wierdak M, Pisarska-Adamczyk M, Wysocki M, Major P, Kolodziejska K, Nowakowski M, et al.Prophylactic negative-pressure wound therapy after ileostomy reversal for the prevention of wound healing complications in colorectal cancer patients: a randomized controlled trial. Techniques in Coloproctology 2021;25:185-93. - PMC - PubMed
Wihbey 2018 {published data only}
    1. Wihbey KA, Joyce EM, Spalding ZT, Jones HJ, MacKenzie TA, Evans RH, et al.Prophylactic negative pressure wound therapy and wound complication after cesarean delivery in women with class II or III obesity: a randomized controlled trial. Obstetrics and Gynecology 2018;132(2):377-84. - PubMed
Witt‐Majchrzac 2015 {published data only}
    1. Witt-Majchrzac A, Żelazny P, Snarska J.Preliminary outcome of treatment of postoperative primarily closed sternotomy wounds treated using negative pressure wound therapy. Polski Przeglad Chirurgiczny 2015;86(10):456-65. - PubMed

References to studies excluded from this review

Abesamis 2019 {published data only}
    1. Abesamis GM, Chopra S, Vickery K, Deva AK.A comparative trial of incisional negative-pressure wound therapy in abdominoplasty. Plastic and Reconstructive Surgery - Global Open 2019;7(5):e2141. - PMC - PubMed
Albert 2012 {published data only}
    1. Albert NM, Rock R, Sammon MA, Bena JF, Morrison SL, Whitman A, et al.Do patient and nurse outcome differences exist between 2 negative pressure wound therapy systems? Journal of Wound Ostomy and Continence Nursing 2012;39:259-66. - PubMed
Al‐Inany 2002 {published data only}
    1. Al-Inany H, Youssef G, ElMaguid AA, Abdel Hamid M, Naguib A.Value of subcutaneous drainage system in obese females undergoing cesarean section using Pfannenstiel incision. Gynecologic and Obstetric Investigation 2002;53(2):75-8. - PubMed
Anderson 2014 {published data only}
    1. Anderson V, Chaboyer W, Gillespie B, Fenwick J.The use of negative pressure wound therapy dressing in obese women undergoing caesarean section: a pilot study. Evidence-Based Midwifery 2014;12:23-8.
Athanasiou 2018 {published data only}
    1. Athanasiou AN, Spartalis M, Spartalis E.Prophylactic negative pressure dressing use in closed laparotomy wounds after abdominal operations. Annals of Surgery 2018;268(1):e19-20. - PubMed
Banasiewicz 2013 {published data only}
    1. Banasiewicz T, Bobkiewicz A, Borejsza-Wysocki M.Portable VAC therapy improve the results of the treatment of the pilonidal sinus - randomized prospective study. Polski Przeglad Chirurgiczny 2013;85:371-6. - PubMed
Bi 2017 {published data only}
    1. Bi XQ, Li Y, Xiao L.Application of modified negative-pressure drainage nursing in neck dissection patients: a randomised controlled trial. International Journal of Oral and Maxillofacial Surgery 2017;46:116.
Bondokji 2011 {published data only}
    1. Bondokji S, Rangaswamy M, Reuter C, Farajalla Y, Mole T, Cockwill J, et al.Clinical efficacy of a new variant of a foam-based NWPT system. Journal of Wound Care 2011;20:64-7. - PubMed
Braakenburg 2006 {published data only}
    1. Braakenburg A, Obdeijn MC, Feitz R, Van Rooij IA, Van Griethuysen AJ, Klinkenbijl JH.The clinical efficacy and cost effectiveness of the vacuum-assisted closure technique in the management of acute and chronic wounds: a randomized controlled trial. Plastic and Reconstructive Surgery 2006;118:390-7. - PubMed
Cantero 2016 {published data only}
    1. Cantero R, Rubio-Perez I, Leon M, Alvarez M, Diaz B, Herrera A, et al.Negative-pressure therapy to reduce the risk of wound infection following diverting loop ileostomy reversal: an initial study. Advances in Skin & Wound Care 2016;29(3):114-8. - PubMed
Chang 2018 {published data only}
    1. Chang EI.Discussion: comparison between negative-pressure fixation and film dressing in wound management after tissue expansion: a randomized controlled trial. Plastic and Reconstructive Surgery 2018;142(1):42-3. - PubMed
Chiang 2017 {published data only}
    1. Chiang N, Rodda OA, Sleigh J, Vasudevan T.Effects of topical negative pressure therapy on tissue oxygenation and wound healing in vascular foot wounds. Journal of Vascular Surgery 2017;66(2):564-71. - PubMed
Chio 2010 {published and unpublished data}
    1. Chio EG, Agrawal A.A randomized, prospective, controlled study of forearm donor site healing when using a vacuum dressing. Otolaryngology - Head and Neck Surgery 2010;142(2):174-8. - PubMed
Cocjin 2019 {published data only}
    1. Cocjin HG, Jingco JK, Tumaneng FD, Coruña JM.Wound-healing following negative-pressure wound therapy with use of a locally developed AquaVac system as compared with the Vacuum-Assisted Closure (VAC) system. Journal of Bone & Joint Surgery, American Volume 2019;101(22):1990-8. - PubMed
Costa 2018 {published data only}
    1. Bruce J, Verdun A, Davis S, Achten J, Parsons N, Hennings S, et al.Using photographic images to aid wound assessment within a randomised controlled trial of standard wound management versus negative pressure wound therapy: UK WOLLF trial. Trials 2017;18(Supple 1):P283 (page 107).
    1. Cook R, Thomas V, Martin R.Negative pressure dressings are no better than standard dressings for open fractures. BMJ Open 2019;364:k4411. - PubMed
    1. Costa ML, Achten J, Bruce J, Davis S, Hennings S, Willett K, et al.Negative-pressure wound therapy versus standard dressings for adults with an open lower limb fracture: the WOLLF RCT. Health Technology Assessment 2018;22(73):1-162. - PMC - PubMed
    1. Costa ML, Achten J, Bruce J, Totton E, Petrou S, Lamb SE, et al.Effect of negative pressure wound therapy vs standard wound management on 12-month disability among adults with severe open fracture of the lower limb: the WOLLF randomized clinical trial. JAMA 2018;319(22):2280-8. - PMC - PubMed
    1. Petrou S, Parker B, Masters J, Achten J, Bruce J, Lamb SE, et al, WOLLF Trial Collaborators.Cost-effectiveness of negative-pressure wound therapy in adults with severe open fractures of the lower limb: evidence from the WOLLF randomized controlled trial. Bone & Joint Journal 2019;101-B(11):1392-401. - PubMed
De Rooij 2020 {published data only}
    1. De Rooij L, Van Kuijk SM, Van Haaren ER, Janssen A, Vissers YL, Beets GL, et al.A single-center, randomized, non-inferiority study evaluating seroma formation after mastectomy combined with flap fixation with or without suction drainage: protocol for the Seroma reduction and drAin fRee mAstectomy (SARA) trial. BMC Cancer 2020;20(1):735. - PMC - PubMed
Dorafshar 2012 {published data only (unpublished sought but not used)}
    1. Dorafshar AH, Franczyk M, Gottlieb LJ, Wroblewski KE, Lohman RF.A prospective randomized trial comparing subatmospheric wound therapy with a sealed gauze dressing and the standard vacuum-assisted closure device. Annals of Plastic Surgery 2011;69(1):79-84. - PubMed
Dragu 2011 {published data only}
    1. Dragu A, Schnurer S, Unglaub F, Wolf MB, Beier JP, Kneser U, et al.Wide topical negative pressure wound dressing treatment for patients undergoing abdominal dermolipectomy following massive weight loss. Obesity Surgery 2011;21(11):1781-6. - PubMed
Echeribi 2015 {published data only}
    1. Echebiri NC, McDoom MM, Aalto MM, Fauntleroy J, Nagappan N, Barnabei VM.Prophylactic use of negative pressure wound therapy after cesarean delivery. Obstetrics & Gynecology 2015;125(2):299-307. - PubMed
Eisenhardt 2012 {published data only}
    1. Eisenhardt SU, Schmidt Y, Thiele JR, Iblher N, Penna V, Torio-Padron N, et al.Negative pressure wound therapy reduces the ischaemia/reperfusion-associated inflammatory response in free muscle flaps. Journal of Plastic, Reconstructive & Aesthetic Surgery 2012;65:640-9. - PubMed
Erne 2018 {published data only}
    1. Erne F, Wetzel S, Wulker N, Gesicki M, Hofmann UK.Closed suction drainage after primary total knee arthroplasty: a prospective randomized trial. Journal of Knee Surgery 2018;31(8):804-10. - PubMed
Fang 2020 {published data only}
    1. Fang C-L, Changchien C-H, Chen M-S, Hsu C-H, Tsai C-B.Closed incision negative pressure therapy following abdominoplasty after breast reconstruction with deep inferior epigastric perforator flaps. International Wound Journal 2020;17(2):326-31. - PMC - PubMed
Fleming 2018 {published data only}
    1. Fleming CA, Kuteva M, O'Hanlon K, O'Brien G, McGreal G.Routine use of PICO dressings may reduce overall groin wound complication rates following peripheral vascular surgery. Journal of Hospital Infection 2018;99(1):75-80. - PubMed
Frazee 2018 {published data only}
    1. Frazee R, Manning A, Abernathy S, Isbell C, Isbell T, Kurek S, et al.Open vs closed negative pressure wound therapy for contaminated and dirty surgical wounds: a prospective randomized comparison. Journal of the American College of Surgeons 2018;226(4):507-12. - PubMed
Grauhan 2013 {published data only}
    1. Grauhan O, Navasardyan A, Hofmann M, Müller P, Stein J, Hetzer R.Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. Journal of Thoracic and Cardiovascular Surgery 2013;145:1387-92. - PubMed
Hu 2009 {published data only}
    1. Hu KX, Zhang HW, Zhou F, Yao G, Shi JP, Wang LF, et al.A comparative study of the clinical effects between two kinds of negative-pressure wound therapy. Zhonghua Shao Shang Za Zhi 2009;24:253-7. - PubMed
Johannesson 2008 {published data only}
    1. Johannesson A, Larsson GU, Oberg T, Atroshi I.Comparison of vacuum-formed removable rigid dressing with conventional rigid dressing after transtibial amputation: similar outcome in a randomized controlled trial involving 27 patients. Acta Orthopaedica 2008;97:361-9. - PubMed
Joos 2015 {published data only}
    1. Joos A.Use of vacuum therapy in pilondal sinus: a randomized controlled study comparing negative pressure wound therapy versus standard wound care after surgical excision [Einsatz der vakuumtherapie beim sinus pilonidalis. Eine randomisierte kontrollierte studie zum vergleich der unterdruck-wundtherapie versus standard-wundversorgung nach chirurgischer exzision]. Coloproctology 2015;37(3):210-2.
Kim 2007 {published data only}
    1. Kim EK, Hong JP.Efficacy of negative pressure therapy to enhance take of 1-stage allodermis and a split-thickness graft. Annals of Plastic Surgery 2007;58:536-40. - PubMed
Kim 2015 {published data only}
    1. Kim YH, Hwang KT, Kim JT, Kim SW.What is the ideal interval between dressing changes during negative pressure wound therapy for open traumatic fractures? Journal of Wound Care 2015;24(11):536-42. - PubMed
Kim 2020 {published data only}
    1. Kim PJ, Lavery LA, Galiano RD, Salgado CJ, Orgill DP, Kovach SJ, et al.The impact of negative-pressure wound therapy with instillation on wounds requiring operative debridement: pilot randomised, controlled trial. International Wound Journal 2020;17(5):1194-208. - PMC - PubMed
Krishnamoorthy 2012 {published data only}
    1. Krishnamoorthy B, Al-Fagih OS, Madi MI, Najam O, Waterworth PD, Fildes JE, et al.Closed suction drainage improves clinical outcome in patients undergoing endoscopic vein harvesting for coronary artery bypass grafting. Annals of Thoracic Surgery 2012;93(4):1201-5. - PubMed
Li 2016 {published data only}
    1. Li PY, Yang D, Liu D, Sun SJ, Zhang LY.Reducing surgical site infection with negative-pressure wound therapy after open abdominal surgery: a prospective randomized controlled study. Scandanavian Journal of Surgery 2016;106(3):189-95. - PubMed
Licari 2020 {published data only}
    1. Licari L, Campanella S, Carolla C, Viola S, Salamone G.Closed incision negative pressure therapy achieves better outcome than standard wound care: clinical outcome and cost-effectiveness analysis in open ventral hernia repair with synthetic mesh positioning. Cureus 2020;5:e8283. - PMC - PubMed
Llanos 2006 {published and unpublished data}
    1. Llanos S, Danilla S, Barraza C, Armijo E, Pineros JL, Quintas M, et al.Effectiveness of negative pressure closure in the integration of split thickness skin grafts. A randomized, double-masked, controlled trial. Annals of Surgery 2006;244(5):700–5. - PMC - PubMed
Lychagin 2021 {published data only}
    1. Lychagin AV, Rosenberg N, Gritsyuk A.Evaluation of the potential complications of surgical wound drainage in primary total hip arthroplasty: a prospective controlled double-blind study. Hip International 2021;31(5):589-92. [DOI: 10.1177/1120700020941749] - DOI - PubMed
Moisidis 2004 {published data only}
    1. Moisidis E, Heath T, Boorer C, Ho K, Deva AK.A prospective, blinded, randomized, controlled clinical trial of topical negative pressure use in skin grafting. Plastic and Reconstructive Surgery 2004;114:917-22. - PubMed
Monsen 2015 {published data only}
    1. Monsen C, Acosta S, Mani K, Wann-Hansson C.A randomised study of NPWT closure versus alginate dressings in peri-vascular groin infections: quality of life, pain and cost. Journal of Wound Care 2015;24(6):252-60. - PubMed
Mouës 2004 {published data only}
    1. Mouës CM, Van den Bemd GJ, Heule F, Hovius SE.A prospective randomized trial comparing vacuum therapy to conventional moist gauze therapy. In: Second World Union of Wound Healing Societies Meeting; 2004 July 8-13; Paris (France). 2004:6. [Abstract A001]
    1. Mouës CM, Van den Bemd GJ, Meerding WJ, Hovius SE.Cost analysis comparing vacuum-assisted closure wound therapy to conventional moist gauze therapy. In: Second World Union of Wound Healing Societies Meeting; 2004 July 8-13; Paris (France). 2004:87. [Abstract A008]
    1. Mouës CM, Vos MC, Van den Bemd GJ, Stijnen T, Hovius SE.Bacterial load in relation to vacuum-assisted closure wound therapy: a prospective randomized trial. Wound Repair and Regeneration 2004;12:11-7. - PubMed
    1. Mouës CM, Vos MC, Van den Bemd GJ, Stijnen T, Hovius SE.Bacterial load in relation to vacuum-assisted closure wound therapy. In: 13th Conference of the European Wound Management Association; 2003 May 22-24; Pisa (Italy). 2003:69.
Mouës 2007 {published data only}
    1. Mouës CM, Van den Bemd GJ, Heule F, Hovius SE.Comparing conventional gauze therapy to vacuum-assisted closure wound therapy: a prospective randomised trial. Journal of Plastic, Reconstructive & Aesthetic Surgery 2007;60:672-81. - PubMed
Mujahid 2020 {published data only}
    1. Mujahid AM, Khalid FA, Ali N, Sajjad Y, Khan H, Tarar MN.Vacuum-assisted closure in integration of skin graft over scalp wounds: a randomised control trial. Journal of the College of Physicians and Surgeons Pakistan 2020;30(2):163-7. - PubMed
Muller‐Sloof 2018 {published data only}
    1. Muller-Sloof E, De Laat HE, Hummelink SL, Peters JW, Ulrich DJ.The effect of postoperative closed incision negative pressure therapy on the incidence of donor site wound dehiscence in breast reconstruction patients: DEhiscence PREvention Study (DEPRES), pilot randomized controlled trial. Journal of Tissue Viability 2018;27(4):262-6. - PubMed
Muoghalu 2019 {published data only}
    1. Muoghalu ON, Eyichukwu GO, Iyidobi E, Anyaehie UE, Madu KA, Okwesili IC.A comparison of the use and non-use of closed suction wound drainage in open reduction and internal fixation of femoral shaft fractures. International Orthopaedics 2019;43(9):2003-8. - PubMed
NCT00724750 {unpublished data only}
    1. NCT00724750.Comparison of two methods of negative pressure wound therapy. clinicaltrials.gov/ct2/show/NCT00724750 (first received 30 July 2008).
Pellino 2014 {published data only}
    1. Pellino G, Sciaudone G, Candilio G, Campitiello F, Selvaggi F, Canonico S.Effects of a new pocket device for negative pressure wound therapy on surgical wounds of patients affected with Crohn's disease: a pilot trial. Surgical Innovation 2014;21:204-12. - PubMed
Petkar 2012 {published data only (unpublished sought but not used)}
    1. Petkar K, Dhanraj P, Sreekar H.Vacuum closure as a skin-graft dressing: a comparison against conventional dressing. European Journal of Plastic Surgery 2012;35:579-84.
Rahmanian‐Schwarz 2012 {published data only}
    1. Rahmanian-Schwarz A, Willkomm LM.A novel option in negative pressure wound therapy (NPWT) for chronic and acute wound care. Handchirurgie Mikrochirurgie Plastiche Chirurgie 2012;38:573-7. - PubMed
Seidel 2020 {published data only}
    1. Seidel D, Diedrich S, Herrle F, Thielemann H, Marusch F, Schirren R, et al.Negative pressure wound therapy vs conventional wound treatment in Subcutaneous Abdominal Wound Healing Impairment: the SAWHI randomized clinical trial. JAMA Surgery 2020;155(6):469-78. - PMC - PubMed
Sinha 2016 {published data only}
    1. Sinha M, Anand HP, Batra A.Coming-of-age in management of post-caesarean surgical-site infections: an ingenious vacuum assisted closure! BJOG 2016;123(S2):152-3.
Stannard 2006 {published data only}
    1. Stannard JP, Robinson JT, Anderson ER, McGwin G Jr, Volgas DA, Alonso JE.Negative pressure wound therapy to treat hematomas and surgical incisions following high-energy trauma. Journal of Trauma 60;6:1301-6. - PubMed
Stannard 2009 {published data only}
    1. Stannard JP, Volgas DA, Stewart R, McGwin G Jr, Alonso JE.Negative pressure wound therapy after severe open fractures: a prospective randomized study. Journal of Orthopaedic Trauma 2009;23(8):552-7. - PubMed
Stapleton 2015 {published data only}
    1. Stapleton H.Wound healing in obese women following caesarean section. Australian Nursing & Midwifery Journal 2015;23(3):34. - PubMed
Svensson‐Bjork 2018 {published data only}
    1. Svensson-Bjork R, Hasselmann J, Acosta S.Evaluation of inguinal vascular surgical scars treated with closed incisional negative pressure wound therapy using three-dimensional digital imaging - a randomized controlled trial on bilateral incisions. Wound Repair and Regeneration 2018;26(1):77-86. - PubMed
Trofa 2019 {published data only}
    1. Trofa DP, Paulino FE, Munoz J, Villacis DC, Irvine JN, Jobin CM, et al.Short-term outcomes associated with drain use in shoulder arthroplasties: a prospective, randomized controlled trial. Journal of Shoulder and Elbow Surgery 2019;28(2):205-11. - PubMed
Visser 2017 {published data only}
    1. Visser R, Milbrandt K, Lum Min S, Wiseman N, Hancock BJ, Morris M, et al.Applying vacuum to accomplish reduced wound infections in laparoscopic pediatric surgery. Journal of Pediatric Surgery 2017;52:849-52. - PubMed
Walker 2018 {published data only}
    1. Walker ME, Tsay C, Broer PN, Zhu VZ, Sturrock T, Ng R, et al.A prospective, randomized-controlled pilot study comparing closed suction versus negative pressure drains for panniculectomy patients. Journal of Plastic, Reconstructive and Aesthetic Surgery 2018;71(3):438-9. - PubMed
Wang 2019 {published data only}
    1. Wang Z.The effects of vacuum sealing drainage on improving the efficacy of reducing wound infection and lower extremity deep venous thrombosis in patients with orthopedic trauma. International Journal of Clinical and Experimental Medicine 2019;12(12):13839-46.
Xu 2019 {published data only}
    1. Xu C, Jia CQ, Kuo FC, Chai W, Zhang MH, Chen JY.Does the use of a closed-suction drain reduce the effectiveness of an antibiotic-loaded spacer in two-stage exchange arthroplasty for periprosthetic hip infection? A prospective, randomized, controlled study. BMC Musculoskeletal Disorders 2019;20(1):583. - PMC - PubMed
Yongchao 2017 {published data only}
    1. Yongchao Y, Zhigang S, Zhiyun X, Xiaofei Y, Chunyu X, Junhui L, et al.Bilayered negative-pressure wound therapy preventing leg incision morbidity in coronary artery bypass graft patients: a randomized controlled trial. Medicine 2017;96(3):1-6. - PMC - PubMed
Yu 2017 {published data only}
    1. Yu Y, Song Z, Xu Z, Ye X, Xue C, Li J, et al.Bilayered negative-pressure wound therapy preventing leg incision morbidity in coronary artery bypass graft patients: a randomized controlled trial. Medicine 2017;96(3):e5925. - PMC - PubMed
Zhang 2020 {published data only}
    1. Zhang JZ, Zhao K, Li JY, Meng HY, Zhu YB, Zhang YZ.Prophylactic closed suction drainage is irrelevant to accelerated rehabilitation after open reduction and internal fixation for closed distal femur fractures. Orthopaedic Audio-Synopsis Continuing Medical Education [Sound Recording] 2020;12(6):1768-75. - PMC - PubMed
Zhuang 2020 {published data only}
    1. Zhuang J, Zheng W, Yang S, Ye J.Modified subcutaneous suction drainage to prevent incisional surgical site infections after radical colorectal surgery. Translational Cancer Research 2020;9(2):910-7. - PMC - PubMed
Zotes 2015 {published data only}
    1. Zotes V, Mier JM, Cortes G.Negative pressure wound therapy in a potentially infected wound after empyema surgery. Interactive CardioVascular and Thoracic Surgery 2015;21:187.

References to studies awaiting assessment

Nagata 2018 {published data only}
    1. Nagata T, Miura K, Homma Y, Fukamizu H.Comparison between negative-pressure fixation and film dressing in wound management after tissue expansion: a randomized controlled trial. Plastic and Reconstructive Surgery 2018;142(1):37-41. - PubMed

References to ongoing studies

ACTRN12615000175572 {unpublished data only}
    1. ACTRN12615000175572.Do suction assisted negative pressure dressings reduce the incidence of surgical site infections after abdominal surgery: a randomized controlled trial. anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12615000175572 (first received 23 February 2015).
ACTRN12618001611213 {published data only}
    1. ACTRN12618001611213 2018.Does the use of negative pressure wound therapy reduce the rate of post operative wound infection after bowel surgery. The effect of PICO dressings on surgical site infection following bowel resection: a randomised controlled trial. apps.who.int/trialsearch/Trial2.aspx?TrialID=ACTRN12618001611213 (first received 28 September 2018).
ACTRN12618002006224 {published data only}
    1. ACTRN12618002006224.Testing the effectiveness of negative pressure wound therapy in the at risk obstetric population for the prevention of surgical wound complications: the CYGNUS Trial. apps.who.int/trialsearch/Trial2.aspx?TrialID=ACTRN12618002006224 (first received 13 December 2018).
ACTRN12619000785101 {unpublished data only}
    1. ACTRN12619000785101.Negative pressure wound therapy to reduce incisional wound infections - a randomised control trial. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377632&isRe... (first received 20 May 2019).
Brennfleck 2020 {published data only}
    1. Brennfleck FW, Linsenmeier L, Junger HH, Schmidt KM, Werner JM, Woeh D, et al.Negative pressure wound therapy (NPWT) on closed incisions to prevent surgical site infection in high-risk patients in hepatopancreatobiliary surgery: study protocol for a randomized controlled trial — the NP-SSI trial. Trials 2020;21(1):918. - PMC - PubMed
    1. DRKS00015136.Negative pressure wound therapy (NPWT) on closed incisions to prevent surgical site infection in HPB-surgery. apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00015136 (first received 19 February 2019).
ChiCTR ‐IOR‐15006439 {unpublished data only}
    1. ChiCTR-IOR-15006439.Prevention surgical site infection with using negative pressure wound therapy in abdominal incision. www.chictr.org.cn/showproj.aspx?proj=11034 (first received 24 May 2015).
CTRI/2019/08/020895 {unpublished data only}
    1. CTRI/2019/08/020895.To study the effect of negative pressure dressings in preventing surgical site infection after emergency midline abdominal surgery. ctri.nic.in/Clinicaltrials/showallp.php?mid1=35648&EncHid=&userN... (first received 23 August 2019).
CTRI/2020/11/028795 {unpublished data only}
    1. CTRI/2020/11/028795.Usage of vaccum therapy in closed abdominal incision in reducing surgical site infection. ctri.nic.in/Clinicaltrials/showallp.php?mid1=48750&EncHid=&userN... (first received 1 November 2020 ).
Donlon 2019 {published data only}
    1. Donlon NE, Boland PA, Kelly ME, Schmidt K, Cooke F, Neary PM, et al.Prophylactic negative wound therapy in laparotomy wounds (PROPEL trial): randomized controlled trial. International Journal of Colorectal Disease 2019;34(11):2003-10. - PubMed
    1. NCT03871023.Prophylactic negative wound therapy in laparotomy wounds. clinicaltrials.gov/show/nct03871023 (first received 7 March 2019).
DRKS00006199 {unpublished data only}
    1. DRKS00006199.Postoperative negative pressure incision therapy following open colorectal surgery: a randomized-controlled trial. www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DR... (first received 20 August 2014).
DRKS00011033 {unpublished data only}
    1. DRKS00011033.Evaluation of negative pressure incisional therapy in urgent gastro-intestinal surgery for reduction of superficial surgical site infections compared to non-occlusive conventional plaster - a prospective, randomized, controlled, multicenter clinical trial. www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DR... (first received 30 August 2016).
DRKS00021494 {unpublished data only}
    1. DRKS00021494.Single use negative pressure wound therapy system (Prevena ™) compared to standard wound care after spinal surgery. www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DR... (first received 5 October 2020).
ISRCTN30055885 {unpublished data only}
    1. ISRCTN30055885.The role of PREVENA vacuum dressings in patients undergoing breast surgery affecting both sides. www.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN30055885 (first received 13 August 2020).
ISRCTN31224450 {unpublished data only}
    1. ISRCTN31224450.Negative pressure therapy in large incisional hernia surgery. www.isrctn.com/ISRCTN31224450 (first received 26 March 2013).
ISRCTN43457163 {unpublished data only}
    1. ISRCTN43457163.Preventing abdominal surgical wound infections with negative pressure wound therapy dressings: Surgical Wound Infection Prevention by Early Intervention using Topical negative pressure therapy – the SWIPE IT trial. www.isrctn.com/ISRCTN43457163 (first received 12 May 2020).
ISRCTN55305726 {unpublished data only}
    1. ISRCTN55305726.WHITE 7 - WHISH – Wound Healing In Surgery for Hip fractures. www.isrctn.com/ISRCTN55305726 (first received 31 May 2017).
Jorgensen 2018 {published data only}
    1. Jorgensen MG, Toyserkani NM, Hyldig N, Chakera AH, Holmich LR, Thomsen JB.Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial. Trials 2018;19(1):441. - PMC - PubMed
JPRN‐UMIN000029706 {unpublished data only}
    1. JPRN-UMIN000029706.Effects of closed incision negative-pressure wound therapy in implant-based breast reconstruction: a randomized controlled trial. upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033947 (first received 25 October 2017).
JPRN‐UMIN000030936 {unpublished data only}
    1. JPRN-UMIN000030936.A randomized phase II study to evaluate efficacy of negative pressure wound therapy on prophylaxis of the incisional hernia after reversal of temporaly diverting stoma. upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035332 (first received 22 January 2018).
Kim 2020b {published data only}
    1. KCT0004063.The effectiveness of negative pressure wound dressing for the wound healing after stoma closure. cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14206 (first received 13 June 2019).
    1. Kim S, Kang SI.The effectiveness of negative-pressure wound therapy for wound healing after stoma reversal: a randomised control study (SR-PICO study). Trials 2020;21(1):24. - PMC - PubMed
Masters 2018 {published data only}
    1. Masters JP, Achten J, Cook J, Dritsaki M, Sansom L, Costa ML.Randomised controlled feasibility trial of standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for hip fractures. BMJ Open 2018;8(4):e020632. - PMC - PubMed
Mihaljevic 2015 {published data only}
    1. Mihaljevic AL, Schirren R, Muller TC, Kehl V, Friess H, Kleeff J.Postoperative negative-pressure incision therapy following open colorectal surgery (Poniy): study protocol for a randomized controlled trial. Trials 2015;16(1):1-11. - PMC - PubMed
NCT01770067 {unpublished data only}
    1. NCT01770067.Prophylactic treatment of high-risk patients with cardiovascular implantable electronic devices (CIED) with continuous in-situ ultra high-dose antibiotics (CITA) under regulated negative pressure-assisted wound therapy (RNPT). clinicaltrials.gov/ct2/show/record/NCT01770067 (first received 17 January 2013).
NCT01891006 {unpublished data only}
    1. NCT01891006.Intervention for postpartum infections following caesarean section (APIPICS). clinicaltrials.gov/ct2/show/NCT01891006 (first received 2 July 2013).
NCT01905397 {unpublished data only}
    1. NCT01905397.Negative pressure wound therapy to reduce surgical site infection. clinicaltrials.gov/show/NCT01905397 (first received 23 July 2013).
NCT02020018 {unpublished data only}
    1. NCT02020018.Negative pressure wound therapy for prevention of poststernotomy infection. clinicaltrials.gov/ct2/show/NCT02020018 (first received 24 December 2013).
NCT02064270 {unpublished data only}
    1. NCT02064270.PICO: a prospective, randomized, controlled clinical study to assess the prevention of postsurgical incision healing complications in patients undergoing primary or revision knee arthroplasty (KA) or total hip arthroplasty (THA), treated with either single-use negative pressure wound therapy (NPWT) or standard postsurgical dressings. clinicaltrials.gov/ProvidedDocs/70/NCT02064270/Prot_SAP_001.pdf (first received 17 Feb 2014).
    1. NCT02064270.Study to compare negative pressure wound therapy or standard dressings after orthopedic surgery (PICO). clinicaltrials.gov/ct2/show/NCT02064270 (first received 17 February 2014).
NCT02118558 {unpublished data only}
    1. NCT02118558.Negative pressure wound therapy – PREVENA – in prevention of infections after total knee arthroplasty (TKA). clinicaltrials.gov/ct2/show/NCT02118558 (first received 21 April 2014).
NCT02302222 {unpublished data only}
    1. NCT02302222.The management of closed surgical incisions resulting from incisional hernia repair and/or functional panniculectomy using the Prevena Customizable Dressing. clinicaltrials.gov/ct2/show/NCT02302222 (first received 26 November 2014).
NCT02331485 {unpublished data only}
    1. NCT02331485.Randomised control study to assess the role of negative pressure wound therapy (NPWT) in the management of wound in surgical patient. clinicaltrials.gov/ct2/show/NCT02331485 (first received 6 January 2015).
NCT02348034 {unpublished data only}
    1. NCT02348034.A randomized controlled trial exploring the ability of negative pressure wound therapy (NPWT) to reduce colorectal surgical site infections (SSI). clinicaltrials.gov/ct2/show/NCT02348034 (first received 28 January 2015).
NCT02408835 {unpublished data only}
    1. NCT02408835.Negative pressure wound therapy in groin dissection. clinicaltrials.gov/ct2/show/record/NCT02408835 (first received 6 April 2015).
NCT02492854 {unpublished data only}
    1. NCT02492854.Standard versus PICO dressings in lower-extremity bypass patients (PICO-LEB). clinicaltrials.gov/ct2/show/NCT02492854 (first received 9 July 2015).
NCT02509260 {unpublished data only}
    1. NCT02509260.Prevena incisional negative pressure wound therapy in re-operative colorectal surgery. clinicaltrials.gov/ct2/show/NCT02509260 (first received 27 July 2015).
NCT02558764 {unpublished data only}
    1. NCT02558764.Effects of preventive negative pressure wound therapy with PICO on surgical wounds of kidney transplant patients. clinicaltrials.gov/ct2/show/NCT02558764 (first received 24 September 2015).
NCT02664168 {unpublished data only}
    1. NCT02664168.A comparative study to assess the prevention of surgical site infection (SSI's) in revision total joint arthroplasty patients treated with single-use negative pressure wound therapy (PICO) or standard care dressings (AQUACEL Ag surgical dressing). clinicaltrials.gov/ct2/show/NCT02664168 (first received 26 January 2016).
NCT02682316 {unpublished data only}
    1. NCT02682316.Negative pressure wound therapy in post-operative incision management. clinicaltrials.gov/ct2/show/NCT02682316 (first received 15 February 2016).
NCT02790385 {unpublished data only}
    1. NCT02790385.Negative pressure wound therapy - a multi-centered randomized control trial (NPWT). clinicaltrials.gov/ct2/show/NCT02790385 (first received 3 June 2016).
NCT02799667 {unpublished data only}
    1. NCT02799667.Do single use negative pressure dressings reduce wound complications in obese women after cesarean delivery? clinicaltrials.gov/ct2/show/NCT02799667 (first received 15 June 2016).
NCT02892435 {unpublished data only}
    1. NCT02892435.Prevena incision management system vs conventional management for wound healing. clinicaltrials.gov/ct2/show/NCT02892435 (first received 8 September 2016).
NCT02901405 {unpublished data only}
    1. NCT02901405.NPWT in soft tissue sarcoma surgery. clinicaltrials.gov/ct2/show/NCT02901405 (first received 15 September 2016).
NCT02901613 {unpublished data only}
    1. NCT02901613.Prophylactic post-cesarean incisional negative-pressure wound therapy in morbidly obese patients. clinicaltrials.gov/ct2/show/NCT02901613 (first received 15 September 2016).
NCT02926924 {unpublished data only}
    1. NCT02926924.Prophylactic application of an incisional wound vac to prevent wound complications in obese spine surgery patients. clinicaltrials.gov/ct2/show/NCT02926924 (first received 6 October 2016).
NCT02954835 {unpublished data only}
    1. NCT02954835.Negative pressure therapy for groin wounds. clinicaltrials.gov/ct2/show/NCT02954835 (first received 3 November 2016).
NCT02967627 {unpublished data only}
    1. NCT02967627.VAC dressings for colorectal resections (VACCRR). clinicaltrials.gov/ct2/show/record/NCT02967627 (first received 18 November 2016).
NCT03000010 {unpublished data only}
    1. NCT03000010.Wound Vac bandage comparison after spinal fusion (WV). clinicaltrials.gov/ct2/show/NCT03000010 (first received 21 December 2016).
NCT03010137 {unpublished data only}
    1. NCT03010137.Incisional negative pressure wound therapy in high risk patients undergoing panniculectomy: a prospective randomized controlled trial. clinicaltrials.gov/ct2/show/NCT03010137 (first received 4 January 2017).
NCT03021668 {unpublished data only}
    1. NCT03021668.Comparison between wound vacuum dressing and standard closure to reduce rates of surgical site infections. clinicaltrials.gov/ct2/show/NCT03021668 (first received 16 January 2017).
NCT03061903 {unpublished data only}
    1. NCT03061903.Closed incision negative pressure therapy vs standard of care (Prevena). clinicaltrials.gov/ct2/show/NCT03061903 (first received 23 February 2017).
NCT03069885 {unpublished data only}
    1. NCT03069885.iNPWT in immediate breast reconstruction. clinicaltrials.gov/ct2/show/record/NCT03069885 (first received 3 March 2017).
NCT03082664 {unpublished data only}
    1. NCT03082664.Negative pressure wound therapy to prevent wound complications following cesarean section in high risk patients. clinicaltrials.gov/ct2/show/NCT03082664 (first received 17 March 2017).
NCT03144726 {unpublished data only}
    1. NCT03144726.RCT on NPWT for incisions following major lower-limb amputation to reduce surgical site infection. clinicaltrials.gov/ct2/show/NCT03144726 (first received 9 May 2017).
NCT03175718 {unpublished data only}
    1. NCT03175718.INPWT on wound complications & clinical outcomes after lower extremity sarcoma surgery preop radiation therapy patients (VAC). clinicaltrials.gov/ct2/show/NCT03175718 (first received 6 June 2018).
NCT03180346 {unpublished data only}
    1. NCT03180346.A prospective, randomized, comparative study to assess the prevention of surgical site infection (SSIs) in revision total joint arthroplasty patients treated with single-use negative pressure wound therapy (PICO) or standard care dressings (AQUACEL Ag Surgical Dressing). clinicaltrials.gov/ct2/show/NCT03180346 (first received 8 June 2017).
NCT03250442 {unpublished data only}
    1. NCT03250442.Evaluating the outcomes for incisional application of negative pressure for nontraumatic amputations. clinicaltrials.gov/ct2/show/NCT03250442 (first received 15 August 2017).
NCT03269968 {unpublished data only}
    1. NCT03269968.Use of negative pressure wound therapy in morbidly obese women after cesarean delivery. clinicaltrials.gov/ct2/show/record/NCT03269968 (first received 1 September 2017).
NCT03274466 {unpublished data only}
    1. NCT03274466.Closed incision negative pressure therapy versus standard of care surgical dressing in revision total knee arthroplasty (PROMISES). clinicaltrials.gov/ct2/show/NCT03274466 (first received 7 September 2017).
NCT03321799 {unpublished data only}
    1. NCT03321799.Comparison of negative pressure wound therapy versus conventional dressings for the prevention of wound complications after revision THA. clinicaltrials.gov/ct2/show/NCT03321799 (first received 26 October 2017).
NCT03345771 {unpublished data only}
    1. NCT03345771.Antimicrobial barrier dressing versus closed-incision negative pressure therapy in the obese primary total joint arthroplasty. clinicaltrials.gov/ct2/show/NCT03345771 (first received 17 November 2017).
NCT03346694 {unpublished data only}
    1. NCT03346694.Reducing surgical site infection rates using an alternative sternal dressing. clinicaltrials.gov/ct2/show/NCT03346694 (first received 17 November 2017).
NCT03395613 {unpublished data only}
    1. NCT03395613.Negative pressure incision management system in infrainguinal vascular surgery. clinicaltrials.gov/ct2/show/NCT03395613 (first received 10 January 2018).
NCT03402945 {unpublished data only}
    1. NCT03402945.Prevention of Infections in Cardiac Surgery (PICS) Prevena study (PICS-Prevena). clinicaltrials.gov/ct2/show/NCT03402945 (first received 18 January 2018).
NCT03414762 {unpublished data only}
    1. NCT03414762.PICO negative pressure wound therapy in obese women undergoing elective cesarean delivery. clinicaltrials.gov/ct2/show/NCT03414762 (first received 30 January 2018).
NCT03458663 {unpublished data only}
    1. NCT03458663.Randomized trial comparing Prevena and ActiV.A.C. system to conventional care after Bascom's cleft lift surgery. clinicaltrials.gov/ct2/show/NCT03458663 (first received 8 March 2018).
NCT03460262 {unpublished data only}
    1. NCT03460262.Negative pressure wound therapy for prevention of groin infection following vascular surgery (PICO). clinicaltrials.gov/ct2/show/NCT03460262 (first received 9 March 2018).
NCT03512470 {unpublished data only}
    1. NCT03512470.Clinical study on the prevention of surgical wound complications for aneurysmal thoracic-abdominal aortic pathology using the "PREVENA" system (TVAC). clinicaltrials.gov/ct2/show/NCT03512470 (first received 20 April 2018).
NCT03632005 {unpublished data only}
    1. NCT03632005.Negative pressure wound therapy vs sterile dressing for patients undergoing thoracolumbar spine surgery. ClinicalTrials.gov/show/NCT03632005 (first received 8 August 2018).
NCT03688438 {unpublished data only}
    1. NCT03688438.WoundVac in obese patients undergoing lumbar surgery. ClinicalTrials.gov/show/NCT03688438 (first received 26 September 2018).
NCT03716687 {unpublished data only}
    1. NCT03716687.Prophylactic negative pressure wound therapy for high risk laparotomy wounds. A randomized prospective clinical trial. clinicaltrials.gov/ct2/show/NCT03716687 (first received 21 October 2018).
NCT03773575 {unpublished data only}
    1. NCT03773575.Evaluation of closed incision negative pressure dressing (PREVENA) to prevent lower extremity amputation wound complications. ClinicalTrials.gov/show/NCT03773575 (first received 10 December 2018).
NCT03781206 {unpublished data only}
    1. NCT03781206.Negative pressure wound therapy for wound healing after stoma reversal. ClinicalTrials.gov/show/NCT03781206 (first received 13 December 2018).
NCT03816293 {unpublished data only}
    1. NCT03816293.SUpPress SSI - single use negative pressure wound therapy (NPWT) to reduce surgical site infections. clinicaltrials.gov/ct2/show/NCT03816293 (first received 22 January 2019).
NCT03820219 {unpublished data only}
    1. NCT03820219.Incisional negative pressure wound therapy in patients undergoing spine surgery. ClinicalTrials.gov/show/NCT03820219 (first received 25 January 2019).
NCT03886818 {unpublished data only}
    1. NCT03886818.Efficacy of negative pressure wound therapy after total ankle arthroplasty. ClinicalTrials.gov/show/NCT03886818 (first received 20 March 2019).
NCT03900078 {unpublished data only}
    1. NCT03900078.Incisional negative pressure wound therapy for resection of soft tissue tumors [Inzisionelle negative drucktherapie nach resektion von weichteiltumoren - eine prospektive, randomisierte, kontrollierte klinische studie]. clinicaltrials.gov/ct2/show/NCT03900078 (first received 26 March 2019).
NCT03905213 {unpublished data only}
    1. NCT03905213.Prevention of surgical wound infection. clinicaltrials.gov/show/nct03905213 (first received 20 March 2019).
NCT03935659 {published data only}
    1. NCT03935659.Negative pressure wound therapy for surgical site infection prevention in common femoral artery exposure. ClinicalTrials.gov/show/NCT03935659 (first received 25 April 2019).
NCT03948412 {unpublished data only}
    1. NCT03948412.Negative pressure wound therapy (PREVENA) versus standard dressings for incision management after renal transplant incision management with Prevena after renal transplant (IMPART) trial. clinicaltrials.gov/ct2/show/NCT03948412 (first received 5 May 2019).
NCT04039659 {unpublished data only}
    1. NCT04039659.POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant: a randomized controlled trial (PONILITRANS). clinicaltrials.gov/ct2/show/NCT04039659 (first received 31 July 2019).
NCT04110353 {unpublished data only}
    1. NCT04110353.Prophylactic closed incision negative pressure wound therapy on abdominal wounds - clinical and economic perspectives: a multi-centre randomised trial. clinicaltrials.gov/ct2/history/NCT04110353?A=2&B=2&C=merged#Stud... (first received 1 October 2019).
NCT04174183 {unpublished data only}
    1. NCT04174183.Evaluation of the effectiveness of a closed-incision negative-pressure therapy (Prevena®) on bilateral groin incision. ClinicalTrials.gov/show/NCT04174183 (first received 22 November 2019).
NCT04214236 {unpublished data only}
    1. NCT04214236.CiNPT for abdominoplasties in post-bariatric patients study. ClinicalTrials.gov/show/NCT04214236 (first received 2January 2020).
NCT04265612 {unpublished data only}
    1. NCT04265612.Effect of the negative pressure therapy dressing compared with the hydrogel dressing on surgical wound infection in cardiac surgery. clinicaltrials.gov/ct2/show/NCT04265612 (first received 11 February 2020).
NCT04434820 {unpublished data only}
    1. NCT04434820.External negative pressure dressing system vs traditional wound dressing for cesarean section incision in obese women. clinicaltrials.gov/ct2/show/NCT04434820 (first received 17 June 2020).
NCT04453319 {unpublished data only}
    1. NCT04453319.Efficacy of negative pressure wound closure therapy by PICO System in prevention of complications of femoral artery exposure. ClinicalTrials.gov/show/NCT04453319 (first received 1 July 2020).
NCT04455724 {unpublished data only}
    1. NCT04455724.Negative pressure incisional wound therapy for high-risk ventral hernia repair. ClinicalTrials.gov/show/NCT04455724 (first received 2 July 2020).
NCT04496180 {unpublished data only}
    1. NCT04496180.Prevena to prevent surgical site infection after emergency abdominal laparotomy. ClinicalTrials.gov/show/NCT04496180 (first received 3 August 2020).
NCT04520841 {unpublished data only}
    1. NCT04520841.Clinical trial comparing negative pressure wound therapy and standard dry dressings: monocentric randomized clinical trial comparing negative pressure wound therapy (PREVENA™) and standard dry dressings on oozing of closed incision after revision total hip and knee arthroplasty surgery or lower extremity amputation surgery. clinicaltrials.gov/ct2/show/NCT04520841 (first received 20 August 2020).
NCT04539015 {unpublished data only}
    1. NCT04539015.Assess the efficacy of Prevena Plus vs SOC to closed incision in pts undergoing CAWR and other laparotomy procedures. ClinicalTrials.gov/show/NCT04539015 (first received 4 September 2020).
NCT04584957 {unpublished data only}
    1. NCT04584957.Prophylactic negative pressure wound therapy (VAC) in Gynecologic Oncology (GO). ClinicalTrials.gov/show/NCT04584957 (first received 14 October 2020).
NCT04618406 {unpublished data only}
    1. NCT04618406.The effect of negative pressure wound therapy on wound healing in major amputations of the lower limb. ClinicalTrials.gov/show/NCT04618406 (first received 5 November 2020).
Nguyen 2017 {published data only}
    1. Nguyen V, Webb M, Neely Panton O.Incisional negative pressure wound therapy following colorectal resection: preliminary report from a single site, prospective, randomized control trial. Surgical Endoscopy 2017;31(Suppl 1):S226.
NL6488 {unpublished data only}
    1. NTR6675.PREventing surgical site occurrences using negative preSSURE wound therapy? The PRESSURE trial. www.trialregister.nl/trialreg/admin/rctview.asp?TC=6675 (first received 6 October 2017).
NTR6481 {unpublished data only}
    1. NTR6481.Randomized controlled clinical trial incisional NPWT versus sterile surgical dressing for surgical wounds after arterial vascular surgery. www.trialregister.nl/trialreg/admin/rctview.asp?TC=6481 (first received 1 June 2017).
Rezk 2019 {unpublished data only}
    1. NCT01913132.PICO above incisions after vascular surgery. clinicaltrials.gov/ct2/show/NCT01913132 (first received 31 July 2013).
    1. Rezk F, Astrand H, Acosta S.Incisional negative pressure wound therapy for the prevention of surgical site infection after open lower limb revascularization - rationale and design of a multi-center randomized controlled trial. Contemporary Clinical Trials Communications 2019;16:no pagination (100469). - PMC - PubMed
Sandy‐Hodgetts 2017 {unpublished data only}
    1. ACTRN12612001275853.Effectiveness of Negative Pressure Wound Therapy (NPWT) in the prevention of post-operative surgical wound dehiscence in at risk patients following abdominal surgery; a multicentre randomised control trial. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362626 (first received 13 June 2012).
    1. Sandy-Hodgetts K, Leslie GD, Parsons R, Zeps N, Carville K.Prevention of postsurgical wound dehiscence after abdominal surgery with NPWT: a multicentre randomised controlled trial protocol. Journal of Wound Care 2017;26(Suppl 2):S23-6. - PubMed
Sandy‐Hodgetts 2020 {unpublished data only}
    1. ACTRN12618000026224p [provisional].Negative pressure dressing in pilonidal surgery. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373010 (first received 2 June 2017).
    1. Sandy-Hodgetts K, Parsons R, Norman R, Fear MW, Wood FM, White SW.Effectiveness of negative pressure wound therapy in the prevention of surgical wound complications in the cesarean section at-risk population: a parallel group randomised multicentre trial - the CYGNUS protocol. BMJ Open 2020;10(10):e035727. - PMC - PubMed
SUNRRISE 2017 {published data only}
    1. ACTRN12619000496112.Single use negative pressure dressing for reduction In surgical site infection following emergency laparotomy. www.who.int/trialsearch/Trial2.aspx?TrialID=ACTRN12619000496112 (first received 27 March 2019).
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