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Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries (VAC-ST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Alabama at Birmingham.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
KCI USA, Inc.
Information provided by (Responsible Party):
Taylor W. Vlack, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00582998
First received: December 20, 2007
Last updated: September 1, 2011
Last verified: March 2011
History of Changes
  Purpose

This project is designed as a prospective, randomized, comparative study evaluating the use of a negative pressure vacuum device in treating soft tissue injuries and the surgical incision following open reduction and internal fixation of calcaneus, tibial plateau, and pilon fractures.


Condition Intervention
Fracture of Calcaneus, Pilon or Tibial Plateau
 Procedure: Standard Wound Dressing
Device: VAC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries Sustained as a Result of Calcaneus, Tibial Plateau and Pilon Fractures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Healing of Orthopaedic Trauma Extremity Wounds: Calcaneus, Pilon and Tibial Plateau Fractures [ Time Frame: Preoperative Phase: 10-21 days; Perioperative Phase: 7 days; Follow-up Phase: 24 months ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: June 2001
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1, A
Standard post-operative wound dressing
 Procedure: Standard Wound Dressing
Following repair of fracture of calcaneus, pilon or tibial plateau, a standard wound dressing is applied in the OR. Dressing is taken down post-op day 1 to evaluate draining, and if necessary, replaced. Dressing will be monitored for drainage every 48 hours until wound is clean, dry and intact.
Active Comparator: 2, B
Vacuum Assisted Closure (VAC) device
 Device: VAC
Following repair of fracture of calcaneus, pilon or tibial plateau, a Vacuum Assisted Closure (VAC) device is applied in the OR. VAC cannister is evaluated for drainage, and if necessary, replaced. VAC sponge will be monitored for drainage every 48 hours, replaced if needed, until wound is clean, dry and intact.
Other Name: Vacuum Assisted Closure (VAC) device

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  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have a closed calcaneus, tibial plateau or pilon fracture requiring open reduction and internal fixation.
  • Adult patients (19 years and older)

Exclusion Criteria:

  • No clinical evidence of infection
  • Patients unable or unwilling to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582998

Locations
United States, Alabama
The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
KCI USA, Inc.
Investigators
Principal Investigator: David A Volgas, MD The University of Alabama at Birmingham
  More Information

Publications:

Responsible Party: Taylor W. Vlack, Study Coordinator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00582998     History of Changes
Other Study ID Numbers: F010316003
Study First Received: December 20, 2007
Last Updated: September 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Vacuum Assisted Closure (VAC)
Calcaneus Fracture
Pilon Fracture
Tibial Plateau Fracture
Open Reduction and Internal Fixation

Additional relevant MeSH terms:
Fractures, Bone
Soft Tissue Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013