Negative Pressure Wound Therapy in Post-Operative Incision Management

Status:	Recruiting
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - Any
Updated:	3/13/2019
Start Date:	February 2016
End Date:	February 2021
Contact:	Mario Leitao, MD
Phone:	212-639-3987

A Phase III Randomized Controlled Trial of Negative Pressure Wound Therapy in Post-Operative Incision Management

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.

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

We found this trial at

sites

Memorial Sloan Kettering Westchester (Consent and follow-up only)

1275 York Avenue
Harrison, New York 10604

Phone: 212-639-3987

from

Harrison, NY