CompletedPhase 3

Negative Pressure Wound Therapy in Post-Operative Incision Management

United States583 participantsStarted 2016-02

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Post-op Wound Complications

Timeframe: 30 days +/- 5 days after surgery

Trial details

NCT IDNCT02682316

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-25

Results submitted2025-01-24