Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery

Status unconfirmed · Not applicable

Conditions studied: Peripheral Artery Disease, Critical Limb Ischemia, Claudication

In brief

The purpose of this study is to evaluate the effectiveness of negative pressure incision management system (Prevena™ Incision Management System (PIMS) or ActiVAC® with the Prevena™ Dressings (Peel and Place™ or Customizable™), KCI) in the prevention of wound complications including surgical site infection (SSI) and non-infectious complications in patients undergoing vascular surgery with groin incisions.

Key facts

Study ID

NCT02389023

Run by

University of Vermont Medical Center

People needed

242

Starts

2015-09-01

Expected to finish

2019-04-01

Last updated by the study team

2018-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Maine Medical Center — Portland, Maine, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Isreal Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• University of Vermont Medical Center — Burlington, Vermont, United States (enrolling)

Full record on ClinicalTrials.gov

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