Negative Pressure Wound Therapy in Post-Operative Incision Management

Phase 3

Completed

Interventions: Other: dry gauze
Device: The Prevena Incision Management System

Brief Summary: 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.

Recruitment & Eligibility

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:

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

Arm && Interventions

Group	Intervention	Description
usual standard dry gauze used for wound management	dry gauze	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.
Prevena Negative Pressure Wound Therapy System (NPWT)	The Prevena Incision Management System	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.

Primary Outcome Measures

Name	Time	Method
number of post-op wound complications	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.

Secondary Outcome Measures

Name	Time	Method

Locations (10): Lehigh Valley Health Network
🇺🇸
Allentown, Pennsylvania, United States
Memorial Sloan Kettering Commack (Consent and Follow-Up only)
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Commack, New York, United States
Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
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Uniondale, New York, United States
Memorial Sloan Kettering Westchester (Consent and Follow-Up only)
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Harrison, New York, United States
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only)
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Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent and Follow-Up only)
🇺🇸
Middletown, New Jersey, United States
Hartford Healthcare Cancer Institute @ Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Memorial Sloan Kettering Rockville (Consent and Follow-Up only)
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Rockville Centre, New York, United States
Memorial Sloan Kettering Bergen (Consent and Follow-Up only)
🇺🇸
Montvale, New Jersey, United States