NCT02954835

Negative Pressure Therapy for Groin Wounds

Negative Pressure Therapy for Closed Groin Wounds in Patients Undergoing Vascular Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Englewood Hospital and Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare wound infection rates between negative pressure therapy (Prevena) and the traditional sterile dry dressing among patients undergoing vascular surgery involving groin incisions.

Detailed description

This is a prospective, investigator-initiated, post-market data collection study comparing wound infection rates among patients undergoing vascular surgery involving groin incisions. Patients will be randomized on the day of surgery to receive the traditional sterile dry dressing or Prevena. Patients with the traditional dressing will undergo dressing changes as per the standard protocol with the first dressing change at postoperative day 2 or 3, or at the discretion of the attending surgeon. The patients with Prevena dressing will have the dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the first outpatient visit. The Primary Objective of this study is to see if using negative pressure therapy decreases the rate of infection. The Secondary Objectives will include multivariate analysis to understand which patients may have a compounded benefit from Prevena (e.g. smokers, diabetics, and obese patients). The Prevena System is an FDA approved bandage and will be used in this study for on-label purposes.

Conditions

• Wound Infection

Interventions

Type	Name	Description
DEVICE	Prevena	Prevena is a sterile silver dressing. On top of the silver dressing is an adhesive plastic, which is connected to a therapy unit through a short length suction tube.
DEVICE	Traditional Dressing	Sterile gauze dressing secured by tape.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-09-03
• Completion: 2019-09-03
• First posted: 2016-11-03
• Last updated: 2020-02-07

Locations

1 site across 1 country: United States