A Phase III Randomized Controlled Trial of Negative Pressure Wound Therapy in Post-Operative Incision Management
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 583
- Locations
- 10
- Primary Endpoint
- Number of Post-op Wound Complications
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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
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
Arms & Interventions
usual standard dry gauze used for wound management
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.
Intervention: dry gauze (Other)
Prevena Negative Pressure Wound Therapy System (NPWT)
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.
Intervention: The Prevena Incision Management System (Device)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported