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

Henry Ford Health System

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Surgical Site Infection Groin Infections

Interventions

Negative Pressure Pressure Wound TherapyDEVICE

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.

Standard Wound CarePROCEDURE

Standard sterile gauze coverage of the primarily closed groin wound.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Henry Ford Hospital

Detroit, Michigan, United States

Outcomes

Primary Outcomes

Superficial surgical site infection

Surgical site infection as defined by the Center for disease control and prevention criteria

Time frame: 30 days postoperatively

Secondary Outcomes

Mortality

Occurrence of mortality within 30 days of surgery

Time frame: 30 days

Limb Loss

Occurrence of ipsilateral limb loss SSI within 30 days and 1 year of surgery

Time frame: 30 days and 1 year

Emergency department visit for wound complication

Number of participants returning to the emergency department for wound complications within 30 days of surgery

Time frame: within 30 days of surgery

Local reaction to negative wound dressing

Occurrence of a local reaction at the site of the negative pressure apparatus during application

Time frame: 5 days postoperatively

Data from ClinicalTrials.gov

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