Phase 3
N=583
Negative Pressure Wound Therapy in Post-Operative Incision Management
Negative-Pressure Wound Therapy
Bottom Line
View on ClinicalTrials.gov: NCT02682316 ↗Enrolled (actual)
583
Serious AEs
23.8%
Results posted
Mar 2025
Primary outcome: Primary: Number of Post-op Wound Complications — 2; 5; 42; 36 Wound Complications
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- dry gauze (Other); The Prevena Incision Management System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Post-op Wound Complications |
2; 5; 42; 36 | — |
Summary
The purpose of this study is to compare any good and bad effects of using the Prevena Incision Management System to using the usual standard dry gauze approach. The Prevena Incision Management System is a type of Negative Pressure Wound Therapy (NPWT). NPWT is a portable vacuum device made of a sponge-like foam that is applied over your incision to help draw fluid and debris out after surgery.
Eligibility Criteria
Inclusion Criteria
Criteria for Eligibility Prior to Surgery:
- Women of any BMI undergoing a laparotomy procedure for a presumed gynecologic malignancy, or morbidly obese (BMI ≥ 40) women undergoing a laparotomy for any indication
- or women who are morbidly obese (BMI>40) undergoing laparotomy for any indication
- Age ≥ 18
Criteria for Eligibility During Surgery:
- Women of any BMI undergoing a laparotomy procedure for a presumed gynecologic malignancy, or morbidly obese (BMI ≥ 40) women undergoing a laparotomy for any indication
- or women who are morbidly obese (BMI>40) undergoing laparotomy for any indication
- Age ≥ 18
Exclusion Criteria
Exclusion prior to Surgery:
- Women undergoing panniculectomy at the time of laparotomy
- Women with sensitivity to silver
Exclusion during Surgery:
- Women with laparotomy incisions left open due to case classification as "contaminated" or "dirty"
- Women with laparotomy incisions unable to be closed primarily due to tissue or fascial damage
Data sourced from ClinicalTrials.gov (NCT02682316). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.