Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
Peripheral Artery Disease, Critical Limb Ischemia, Claudication
About this trial
This is an interventional prevention trial for Peripheral Artery Disease focused on measuring surgical site infection, infrainguinal bypass, incisional wound vacuum assisted closure, Prevena
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18
- Patient undergoing vascular surgery that would include a groin incision as a standard part of the operation. Infrainguinal bypass including femoral popliteal/tibial/pedal artery bypass with autogenous or prosthetic conduit.
- femoral endarterectomy with or without patch angioplasty involving the common femoral artery and/or profunda and/or proximal superficial artery. The index groin may have undergone prior procedures (may be inflow or outflow for existing grafts), but the patient must have fully healed from the prior operation. May include patients with concomitant proximal and/or distal peripheral vascular intervention. The patch may be autogenous venous or arterial or prosthetic material such as bovine pericardium, dacron or polytetrafluoroethylene (PTFE). Bilateral femoral endarterectomies are eligible for enrollment. The right and left groin incision would be randomized to the same dressing which is consistent with routine clinical practice.
- Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.
Exclusion Criteria:
- Any groin incision on index leg within 12 weeks prior to treatment initiation.
- Infrainguinal bypass without a groin incision including popliteal-tibial or pedal bypass.
- Supra inguinal procedures such as open or endovascular abdominal aortic aneurysm repair or aorto-femoral/bi-femoral bypass for occlusive disease.
- Undergoing current chemotherapy or radiation therapy.
- Pregnancy or lactation.
- Inability or refusal to provide informed consent.
- Patients who received an investigational drug for peripheral arterial disease within 4 weeks of screening or who participated in another non-observational clinical trial in the prior 30 days.
- Surgical incision in the groin without primary closure including previously open or infected wounds.
- Sensitivity or allergy to silver.
- Prior enrollment in this randomized controlled trial.
Sites / Locations
- Maine Medical CenterRecruiting
- Brigham and Women's HospitalRecruiting
- Beth Isreal Deaconess Medical CenterRecruiting
- Dartmouth Hitchcock Medical CenterRecruiting
- University of Vermont Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Other
standard gauze dressing
Prevena Incision Management System
a standard post-operative dressing consisting of dry gauze and tape will be placed over the surgical site
the Prevena™ Incision Management System (PIMS) or ActiVAC® with the PrevenaTM Dressings (Peel and Place™ or Customizable™) will be placed over the surgical site. The Prevena dressing is not considered experimental and has FDA approval for coverage of at risk closed-surgical incisions. The dressing is already in clinical use for vascular surgery bypass operations at the University of Vermont Medical Center.