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Vacuum Assisted Closure as a Treatment for Open Fractures

NCT00582361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2013-08-14

Study results available
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Summary

This project is designed as a prospective, randomized, comparative study evaluating the use of a negative pressure vacuum device in treating traumatic wounds sustained associated with an open fracture.

Conditions

  • Orthopaedic Traumatic Open Fractures

Interventions

PROCEDURE

Standard Wound Dressing

Group A patients will have a standard dressing applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.

DEVICE

VAC

Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.

Sponsors & Collaborators

  • KCI USA, Inc

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Rena L Stewart, MD · The University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2008-09-30
Completion
2010-01-31

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 NCT00582361 on ClinicalTrials.gov