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Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery

NCT02836990 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-12-28

Study results available
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Summary

This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision Management System versus Dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond and the other half will receive the Prevena Incision Management System for their groin wounds.

Conditions

  • Wound Infection

Interventions

DEVICE

Prevena Incision Management System

A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections

DEVICE

Dermabond

A surgical skin adhesive used to prevent surgical wound infections

Sponsors & Collaborators

  • KCI USA, Inc

    collaborator INDUSTRY

  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • Linda Harris, MD · State University of New York at Buffalo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • United States

Study Locations

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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 NCT02836990 on ClinicalTrials.gov