Negative Pressure Therapy for Groin Wounds
Primary Purpose
Wound Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prevena
Traditional Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Wound Infection
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing vascular surgery with a groin incision.
Exclusion Criteria:
- Allergy to silver.
Sites / Locations
- Englewood Hospital and Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Prevena
Traditional Dressing
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Infection rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02954835
First Posted
November 2, 2016
Last Updated
February 5, 2020
Sponsor
Englewood Hospital and Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02954835
Brief Title
Negative Pressure Therapy for Groin Wounds
Official Title
Negative Pressure Therapy for Closed Groin Wounds in Patients Undergoing Vascular Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 3, 2019 (Actual)
Study Completion Date
September 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Englewood Hospital and Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prevena
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Traditional Dressing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Prevena
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional Dressing
Intervention Description
Sterile gauze dressing secured by tape.
Primary Outcome Measure Information:
Title
Infection rate
Time Frame
17 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing vascular surgery with a groin incision.
Exclusion Criteria:
Allergy to silver.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bernik, MD
Organizational Affiliation
Englewood Hospital and Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.englewoodhealth.org
Description
hospital public website
Learn more about this trial
Negative Pressure Therapy for Groin Wounds
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