Negative Pressure Therapy for Groin Wounds

Sponsor

Englewood Hospital and Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02954835

Collaborator

(none)

Enrollment

Location

Arms

33.1

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Wound Infection	Device: Prevena Device: Traditional Dressing	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Sep 3, 2019

Actual Study Completion Date :

Sep 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prevena Subjects randomized to the Prevena dressing will have the dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the first outpatient visit.	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.
Active Comparator: Traditional Dressing Subjects randomized to 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.	Device: Traditional Dressing Sterile gauze dressing secured by tape.

Arm

Intervention/Treatment

Active Comparator: Prevena

Subjects randomized to the Prevena dressing will have the dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the first outpatient visit.

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.

Active Comparator: Traditional Dressing

Subjects randomized to 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.

Device: Traditional Dressing

Sterile gauze dressing secured by tape.

Outcome Measures

Primary Outcome Measures

Infection rate [17 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing vascular surgery with a groin incision.

Exclusion Criteria:

Allergy to silver.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Englewood Hospital and Medical Center	Englewood	New Jersey	United States	07631

Sponsors and Collaborators

Englewood Hospital and Medical Center

Investigators

Principal Investigator: Thomas Bernik, MD, Englewood Hospital and Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

hospital public website

Publications

None provided.

Responsible Party:

Englewood Hospital and Medical Center

ClinicalTrials.gov Identifier:

NCT02954835

Other Study ID Numbers:

E-16-679

First Posted:

Nov 3, 2016

Last Update Posted:

Feb 7, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Wound Infection

Wounds and Injuries

Study Results

No Results Posted as of Feb 7, 2020