Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Common Femoral Artery Exposure

February 8, 2021 updated by: loay kabbani, MD, Henry Ford Health System

Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Vascular Surgery Patients Undergoing Common Femoral Artery Exposure

The purpose of this randomized clinical trial is to investigate the role of negative pressure wound therapy (NPWT) vs standard sterile gauze therapy on the incidence of surgical site infections (SSI) in primarily closed groin incisions in high risk patients undergoing any open common femoral artery exposure for a vascular surgery procedure.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Eligible patients are randomized pre-operatively into either a standard dressing or NPWT for the groin incision.

  • 1 The control group receive a standard sterile gauge dressing over the groin incision. The dressing is removed on post-operative day #2 and the wound is inspected for a SSI or dehiscence, followed by daily dressing changes and wound inspections until discharge.
  • 2 The intervention group will receive a NPWT dressing which will be applied in the operating room under sterile conditions. The NPWT dressing will be removed on Post operative day 5. The wound is inspected for a SSI or dehiscence, followed by daily dressing changes and wound inspections until discharge.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: One or more of the following

  • Body Mass Index >30 kg/m2
  • Critical limb ischemia defined by Ankle Brachial Index<0.35, rest pain, tissue loss and/or non-healing ulcers
  • Procedure time >240 min
  • End Stage Renal Disease on dialysis
  • Glycated hemoglobin ≥ 8.5%
  • Transfusion ≥ 3 units packed Red Blood Cells
  • Previous femoral artery cut-down

Exclusion Criteria:Any of the following

  • Preexisting groin infection
  • Complete vacuum seal cannot be achieved with negative pressure device
  • Allergy to Adhesive Material
  • Groin Surgery within last 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard gauze therapy
The control group will receive a standard sterile gauge dressing over the groin incision. The dressing will be removed on post-operative day #2 and the wound will be inspected for any complications, followed by daily dressing changes and wound inspections until discharge.
Procedure: Standard Wound Care
Standard sterile gauze coverage of the primarily closed groin wound.
Experimental: Negative Pressure wound therapy
The intervention group will receive a negative pressure dressing which will be applied in the operating room under sterile conditions. The brand of negative pressure dressing will be based on surgeon preference or center availability. The NPWT dressing will be removed on day 5 postoperatively or at discharge, whichever occurs first, and the groin wound inspected for any evidence of infection or dehiscence, and daily thereafter until discharge.
Device: Negative Pressure Pressure Wound Therapy
Investigators will be using a Negative Pressure Wound Therapy Powered Suction Pump on primarily closed groin wounds after open common femoral artery exposure, The Negative pressure dressing will be applied in a sterile fashion in the operating room. The negative pressure dressing will be removed at day 5 postoperatively, or at discharge, whichever occurs first.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superficial surgical site infection
Time Frame: 30 days postoperatively
Surgical site infection as defined by the Center for disease control and prevention criteria
30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
Occurrence of mortality within 30 days of surgery
30 days
Limb Loss
Time Frame: 30 days and 1 year
Occurrence of ipsilateral limb loss SSI within 30 days and 1 year of surgery
30 days and 1 year
Emergency department visit for wound complication
Time Frame: within 30 days of surgery
Number of participants returning to the emergency department for wound complications within 30 days of surgery
within 30 days of surgery
Local reaction to negative wound dressing
Time Frame: 5 days postoperatively
Occurrence of a local reaction at the site of the negative pressure apparatus during application
5 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Loay Kabbani, MD, Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2018

Primary Completion (Anticipated)

March 31, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 2, 2019

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11956

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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