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

NCT02389023 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2018-12-12

No results posted yet for this study

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

Interventions

OTHER

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

OTHER

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.

Sponsors & Collaborators

  • KCI USA, Inc

    collaborator INDUSTRY

  • MaineHealth

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    collaborator OTHER

  • University of Vermont Medical Center

    lead OTHER

Principal Investigators

  • Daniel J Bertges, MD · University of Vermont Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02389023 on ClinicalTrials.gov