Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Common Femoral Artery Exposure
- Conditions
- Groin InfectionsSurgical Site Infection
- Interventions
- Device: Negative Pressure Pressure Wound TherapyProcedure: Standard Wound Care
- Registration Number
- NCT03935659
- Lead Sponsor
- Henry Ford Health System
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Negative Pressure wound therapy Negative Pressure 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. Standard gauze therapy Standard Wound Care 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.
- Primary Outcome Measures
Name Time Method Superficial surgical site infection 30 days postoperatively Surgical site infection as defined by the Center for disease control and prevention criteria
- Secondary Outcome Measures
Name Time Method Mortality 30 days Occurrence of mortality within 30 days of surgery
Local reaction to negative wound dressing 5 days postoperatively Occurrence of a local reaction at the site of the negative pressure apparatus during application
Limb Loss 30 days and 1 year Occurrence of ipsilateral limb loss SSI within 30 days and 1 year of surgery
Emergency department visit for wound complication within 30 days of surgery Number of participants returning to the emergency department for wound complications within 30 days of surgery
Trial Locations
- Locations (1)
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States