Clinical trial · Interventional
Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.)
Prophylactic Negative Pressure Wound Therapy in Gynecologic Oncology: a Prospective Controlled Randomized Trial. (GO-VAC)
NCT04584957CI-TRIAL-00047642GO-VACunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective controlled randomized study aimed to prospectively evaluate, the impact and effectiveness of clean incision prophylactic vacuum negative pressure therapy on wound healing (ciNPWT) in women at high risk of developing wound complications who undergo major gynecologic surgery. Gynecologic Oncology patients appear to be more at risk of developing wound complications than the general surgery population, reaching infection rates of 36 vs. 24 % that become 40 and 60% for obese and morbidly obese patients, respectively. Data about the use of ciNPWT are few, controversial and are of poor quality. No randomized, controlled trials have yet been reported in support of the use of ciNPWT in the gynecologic population.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Wound Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VAC therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- VAC therapy
- description
- Prophylactic ciNPWT therapy positioning YES. Patients enrolled for placement of the device over a closed incision immediately post-operatively.
- interventionNames
- Device: VAC therapy
- type
- NO_INTERVENTION
- label
- Standard Closure
- description
- Prophylactic ciNPWT therapy positioning NO. Patients enrolled for standard laparotomic closure without ciNPWT positioning
Primary outcomes (1)
- measure
- Change of the rate of surgical site infections at 15 days
- timeFrame
- 15 days
- description
- To investigate whether the application of an ciNPWT device (Prevena Incision Management System, KCI, Inc., San Antonio, TX, USA) change the rate of surgical site infections (SSI) within 15 postoperative days in gynecologic oncology patients undergoing surgery, from 35 % to 15 %.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: All patients subjected to midline incision (xiphoid-pubic/sub-xiphoid/umbilical-pubic incision) with: * Moderate/Severe (Aletti score ≥3) Modified surgical complexity score in: * Ovarian cancer: primary debulking surgery (PDS) or interval debulking surgery (IDS) (minimum total hysterectomy+bilateral salpingo-oophorectomy+lymphadenectomy in early ovarian cancer \[EOC\] should be done to include the patient in the trial) or secondary debulking surgery at recurrence (SCS). * Endometrial cancer FIGO stage IV or staging surgery for high risk endometrial cancer * Uterine Sarcomas FIGO stage IIB-IV * Previous history of pelvic or abdominal radiotherapy (even locally advanced cervical cancer \[LACC\] post neoadjuvant (NAD) therapies \[NAD chemo-radiation or chemotherapy alone\]) * Persistent or recurrent Cervical cancer * Obesity (\>30 Kg/sqm) in all Aletti score surgery and in all FIGO stage malignancies * Controlled diabetes mellitus in all Aletti score surgery and all FIGO stage malignancies * Heavy smokers ≥ 20 cigarettes a day in all Aletti score surgery and all FIGO stage malignancies. Exclusion Criteria: * uncontrolled diabetes mellitus * severe cardiac dysfunction * pregnancy * underweight (body mass index \[BMI\] \< 18.5 kg/sqm) * long-term steroid use * subcutaneous (e.g. Jackson Pratt) drainage positioning * post-operative prophylactic use of antibiotics beyond the intraoperative short therapy * contaminated (class III) and dirty/infected (class IV) incision \[10\] * allergy to silver
References
Publications (11)
- BACKGROUNDPerencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232. PMID 12603990
- BACKGROUNDWechter ME, Pearlman MD, Hartmann KE. Reclosure of the disrupted laparotomy wound: a systematic review. Obstet Gynecol. 2005 Aug;106(2):376-83. doi: 10.1097/01.AOG.0000171114.75338.06. PMID 16055590
- BACKGROUNDNugent EK, Hoff JT, Gao F, Massad LS, Case A, Zighelboim I, Mutch DG, Thaker PH. Wound complications after gynecologic cancer surgery. Gynecol Oncol. 2011 May 1;121(2):347-52. doi: 10.1016/j.ygyno.2011.01.026. Epub 2011 Feb 15. PMID 21324517
- BACKGROUNDKim SI, Lim MC, Song YJ, Seo SS, Kang S, Park SY. Application of a subcutaneous negative pressure drain without subcutaneous suture: impact on wound healing in gynecologic surgery. Eur J Obstet Gynecol Reprod Biol. 2014 Feb;173:94-100. doi: 10.1016/j.ejogrb.2013.12.006. Epub 2013 Dec 15. PMID 24388401
- BACKGROUNDKim SI, Lim MC, Bae HS, Shin SR, Seo SS, Kang S, Park SY. Benefit of negative pressure drain within surgical wound after cytoreductive surgery for ovarian cancer. Int J Gynecol Cancer. 2015 Jan;25(1):145-51. doi: 10.1097/IGC.0000000000000315. PMID 25386858
- BACKGROUNDScalise A, Calamita R, Tartaglione C, Pierangeli M, Bolletta E, Gioacchini M, Gesuita R, Di Benedetto G. Improving wound healing and preventing surgical site complications of closed surgical incisions: a possible role of Incisional Negative Pressure Wound Therapy. A systematic review of the literature. Int Wound J. 2016 Dec;13(6):1260-1281. doi: 10.1111/iwj.12492. Epub 2015 Oct 1. PMID 26424609
- BACKGROUNDWilly C, Agarwal A, Andersen CA, Santis G, Gabriel A, Grauhan O, Guerra OM, Lipsky BA, Malas MB, Mathiesen LL, Singh DP, Reddy VS. Closed incision negative pressure therapy: international multidisciplinary consensus recommendations. Int Wound J. 2017 Apr;14(2):385-398. doi: 10.1111/iwj.12612. Epub 2016 May 12.