Negative Pressure Wound Therapy in Post-Operative Incision Management

Study Overview
=================
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.

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

Conditions
-----------------
Negative-Pressure Wound Therapy

Intervention / Treatment
-----------------
* Other: dry gauze
* Device: The Prevena Incision Management System


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: usual standard dry gauze used for wound management<br>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. | Other: dry gauze<br> <br> |
| Experimental: Prevena Negative Pressure Wound Therapy System (NPWT)<br>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. | Device: The Prevena Incision Management System<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of post-op wound complications | 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. | 30 days +/- 5 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
15-309, undergoing laparotomy