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

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

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.

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.

Patient fulfilling the inclusion criteria will be randomized into a standard gauze therapy group or a negative pressure wound therapy group.

As this intervention necessitated the use of an external negative wound therapy device, masking is not possible

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.

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.

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.

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

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

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