Negative Pressure Wound Therapy in Post-Operative Incision Management

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