Negative Pressure Wound Therapy in Post-Operative Incision Management
Completed · Phase 3
Conditions studied: Negative-Pressure Wound Therapy
In brief
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.
Key facts
- Study ID
- NCT02682316
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 583
- Starts
- 2016-02-01
- Expected to finish
- 2024-01-25
- Last updated by the study team
- 2025-03-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hartford Healthcare Cancer Institute @ Hartford Hospital — Hartford, Connecticut, United States
- Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only) — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (Consent and Follow-Up only) — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (Consent and Follow-Up only) — Montvale, New Jersey, United States
- Memorial Sloan Kettering Commack (Consent and Follow-Up only) — Commack, New York, United States
- Memorial Sloan Kettering Westchester (Consent and Follow-Up only) — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Memorial Sloan Kettering Rockville (Consent and Follow-Up only) — Rockville Centre, New York, United States
- Memorial Sloan Kettering Nassau (Consent and Follow-Up only) — Uniondale, New York, United States
- Lehigh Valley Health Network — Allentown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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