Negative Pressure Wound Therapy in Post-Operative Incision Management

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 3

Conditions: Negative-Pressure Wound Therapy

Treatments: Device: The Prevena Incision Management System; Other: dry gauze

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02682316

15-309

Details and patient eligibility

About

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.

Enrollment: 583 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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583 participants in 2 patient groups

usual standard dry gauze used for wound management

Active Comparator group

Description:

Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice.

Treatment:

Other: dry gauze

Prevena Negative Pressure Wound Therapy System (NPWT)

Experimental group

Description:

Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first.

Treatment:

Device: The Prevena Incision Management System