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

Description

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

September 2015

Estimated Completion Date

April 2018

Interventions

  • Other: Prevena Incision Management system
  • Other: standard gauze dressing

Specialties

  • Cardiology: Vascular Medicine
  • Physician Assistant: Cardiology

MeSH Terms

  • Peripheral Arterial Disease

Study ID

University of Vermont Medical Center -- 15371

Status

Unknown

Trial ID

NCT02389023

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

242

Sponsor

University of Vermont Medical Center

Inclusion Criteria

    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.

Exclusion Criteria

    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 bypass. 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 infected wounds. 9. Sensitivity or allergy to silver. 10. Prior enrollment in this randomized controlled trial.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Beth Isreal Deaconess Medical Center - Boston, Massachusetts 2.4 miles Mark Wyers MD 617-632-9847 mwyers@bidmc.harvard.edu
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 RN 802-656-9921 lisa.smith@uvm.edu

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