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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Surgical Site Infection, Groin Infections

Intervention / Treatment
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* Device: Negative Pressure Pressure Wound Therapy
* Procedure: Standard Wound Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient fulfilling the inclusion criteria will be randomized into a standard gauze therapy group or a negative pressure wound therapy group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard gauze therapy<br>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<br>* Standard sterile gauze coverage of the primarily closed groin wound.<br>|
| Experimental: Negative Pressure wound therapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superficial surgical site infection | 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 | Occurrence of mortality within 30 days of surgery | 30 days | 
| Limb Loss | 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 | 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 | Occurrence of a local reaction at the site of the negative pressure apparatus during application | 5 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Negative Pressure Wound Therapy