Recruiting

Prevena vs. Standard Dressing

Sponsor:

University of Vermont Medical Center

Code:

NCT02389023

Conditions

Peripheral Artery Disease

Critical Limb Ischemia

Claudication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

standard gauze dressing

Prevena Incision Management system

Study Details

Brief summary:

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.

Conditions

Peripheral Artery Disease

Critical Limb Ischemia

Claudication

Study ID

NCT02389023

Start date

Sep, 2015

Status verified date

Dec, 2018

Completion date

Apr, 2019

Anticipated

Primary completion date

Apr, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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. 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.
4. 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.

Study Design

Enrollment

242 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: standard gauze dressing

a standard post-operative dressing consisting of dry gauze and tape will be placed over the surgical site

other: Prevena Incision Management System

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.

Interventions

standard gauze dressing

Standard gauze dressing with tape will be placed over the surgical incision in the operating room and left on the incision as dictated by standard of care

Prevena Incision Management system

The Prevena dressing system over the closed surgical incision. The dressing consists of a sterile sponge that is placed over the incision followed by a plastic adhesive covering that is used to secure it to the skin forming an air-tight seal. The sponge is then connected by tubing to a vacuum that applies negative pressure to the closed system. This allows fluid to drain from the wound and into a container connected to the dressing.

Primary outcome measure

  • The primary outcome measure will be a composite endpoint of surgical site infection as per Center for Disease Control definition, major wound non-infectious complications, or graft infection within 30 days of surgery. [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Contacts

Jens Eldrup-Joregensen, MD

207-774-6368JorgeJ@mmc.org

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Beth Isreal Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Principal Investigator:

Daniel Bertges, MD

More Information

Sponsor

University of Vermont Medical Center

Last update posted

Dec 12, 2018

Last verified

Dec, 2018

Keywords

  • surgical site infection
  • infrainguinal bypass
  • incisional wound vacuum assisted closure
  • Prevena

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont Medical Center on 2018-12-12.