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.

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Key information

Conditions

Negative-Pressure Wound Therapy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hartford Healthcare Cancer Institute @ Hartford Hospital, Hartford, Connecticut, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry gauze

Other

The Prevena Incision Management System

Device

Primary outcomes

Number of Post-op Wound Complications

Time frame: 30 days +/- 5 days after surgery

Incidence of inpatient post-operative wound complications will be documented through the use of an inpatient data collection sheet. Incidence of outpatient post-operative wound complication will be documented through the use of an outpatient data collection sheet that will be completed by a provider at the time of the routine post-operative follow-up visit, which will occur at 30 days +/- 5 days after the day of surgery as well as through ongoing documentation of events as elicited through the institution's standard reporting system to collect information on enrolled patients.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

3M
Miami Cancer Institute

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2024
Study completion: 2024
First posted: Feb 15, 2016
Registry last updated: Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed