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

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ClinicalTrials.gov Identifier: NCT00582998
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : September 20, 2013
Sponsor:
Collaborator:
KCI USA, Inc.
Information provided by (Responsible Party):
Taylor W. Vlack, University of Alabama at Birmingham

Brief Summary:
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 or disease Intervention/treatment Phase
Fracture of Calcaneus, Pilon or Tibial Plateau Procedure: Standard Wound Dressing Device: VAC Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2001
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

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U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013

Keywords provided by Taylor W. Vlack, 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