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

Henry Ford Health

Status: Withdrawn

Conditions: Groin Infections; Surgical Site Infection

Treatments: Procedure: Standard Wound Care; Device: Negative Pressure Pressure Wound Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03935659

11956

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Standard gauze therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard Wound Care

Negative Pressure wound therapy

Experimental group

Description:

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.

Treatment:

Device: Negative Pressure Pressure Wound Therapy