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| Sponsors and Collaborators: |
University of Alabama at Birmingham KCI USA, Inc. |
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| Information provided by: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00582998 |
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 |
|---|---|
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Fracture of Calcaneus, Pilon or Tibial Plateau |
Procedure: Standard Wound Dressing Device: VAC |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries Sustained as a Result of Calcaneus, Tibial Plateau and Pilon Fractures |
| Enrollment: | 189 |
| Study Start Date: | June 2001 |
| Estimated Study Completion Date: | November 2008 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1, A: Active Comparator
Standard post-operative wound dressing
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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.
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2, B: Active Comparator
Vacuum Assisted Closure (VAC) device
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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.
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Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| The University of Alabama at Birmingham, Orthopaedic Trauma | |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: | James P Stannard, MD | The University of Alabama at Birmingham |
More Information
| Responsible Party: | The University of Alabama at Birmingham ( James P. Stannard, MD, Professor of Surgery, Assoc. Director of Orthopaedic Surgery ) |
| Study ID Numbers: | F010316003, VAC2001-05 |
| Study First Received: | December 20, 2007 |
| Last Updated: | December 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00582998 |
| Health Authority: | United States: Institutional Review Board |
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Vacuum Assisted Closure (VAC) Calcaneus Fracture Pilon Fracture Tibial Plateau Fracture Open Reduction and Internal Fixation |
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Soft Tissue Injuries Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |
