Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
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.
Study Start Date
Estimated Completion Date
- Other: Prevena Incision Management system
- Other: standard gauze dressing
- Cardiology: Vascular Medicine
- Physician Assistant: Cardiology
- Peripheral Arterial Disease
University of Vermont Medical Center -- 15371
University of Vermont Medical Center
1. Age ? 18
2. 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.
3. Willing to comply with protocol, attend follow-up appointments, complete all study
assessments, and provide written informed consent.
1. Any groin incision on index leg within 12 weeks prior to treatment initiation.
2. Infrainguinal bypass without a groin incision including popliteal-tibial or pedal
3. Supra inguinal procedures such as open or endovascular abdominal aortic aneurysm
repair or aorto-femoral/bi-femoral bypass for occlusive disease.
4. Undergoing current chemotherapy or radiation therapy.
5. Pregnancy or lactation.
6. Inability or refusal to provide informed consent.
7. 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.
8. Surgical incision in the groin without primary closure including previously open or
9. Sensitivity or allergy to silver.
10. Prior enrollment in this randomized controlled trial.
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (4)
|Beth Isreal Deaconess Medical Center - Boston, Massachusetts||2.4 miles||Mark Wyers MDemail@example.com|
|Brigham and Womens Hospital - Boston, Massachusetts||2.6 miles||Keith Ozaki MD||857-307-1920||CKOZAKI@PARTNERS.ORG|
|Maine Medical Center - Portland, Maine||99.0 miles||Jens EldrupJoregensen MD||207-774-6368||JorgeJ@mmc.org|
|University of Vermont Medical Center - Burlington, Vermont||181.7 miles||Lisa Smith RNfirstname.lastname@example.org|