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Incisional Negative Pressure Dressing on Clean Closed Groin Incisions

NCT02006511 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-05-06

No results posted yet for this study

Summary

Wound complications associated with surgical incisions range from minor to life threatening. Surgical site infections occurring usually occur within 30 days and are one of the most common surgical complications. Perigraft infections in groin wounds can be devastating. Even superficial wounds can progress to deep wounds resulting in graft infection, need for explantation, and sepsis or amputation requirement. Negative pressure wound therapy has had favorable results on closed wounds in trauma populations. Similarly, negative pressure wound therapy has had positive benefits in closed incisions such as sternal wounds following cardiac surgery. As a result, the PrevenaTM Incision Management System(IMS) was developed to allow easier application of negative pressure therapy to closed wounds. Application of the PrevenaTM IMS dressing would portend the aforementioned benefits of Vacuum Assisted Closure (VAC®) therapy with the added benefits of protecting the wound from contamination and bolstering the wound edges for better approximation and consequently better aesthetic outcome. However, no comparison between negative pressure therapy as a dressing and standard wound dressings exists.

The purpose of this study is to assess the efficacy and safety of topical negative pressure therapy application with Prevena™ versus standard of care wound therapy on closed groin incisions in high risk patients undergoing vascular surgery.

Conditions

  • Complication of Surgical Procedure

Interventions

DEVICE

Incisional Neg Pressure Wound Therapy (Prevena™)

Negative pressure wound therapy dressing applied over closed surgical incision

OTHER

Standard of Care wound therapy

Gauze type dressing.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Rachel Bluebond-Langer, MD · University of Maryland, School of Medicine, Dept of Surgery, Division of Plastic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-01
Primary Completion
2014-12-01
Completion
2014-12-01

Countries

  • United States

Study Locations

More Related Trials

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 NCT02006511 on ClinicalTrials.gov