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Vacuum Assisted Closure as a Treatment for Open Fractures (VAC-OF)

This study has been completed.
Sponsor:
Collaborator:
KCI USA, Inc.
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00582361
First received: December 20, 2007
Last updated: December 13, 2012
Last verified: May 2012
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 traumatic wounds sustained associated with an open fracture.


Condition Intervention
Orthopaedic Traumatic Open Fractures
 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 Open 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 Open Fractures [ Time Frame: Initial Treatment : 2-3 days; Postoperative: 0-5 days; Follow-up: 12 months ] [ Designated as safety issue: No ]
  • Infections [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    How many acute, delayed or deep wound infections per arm


Enrollment: 63
Study Start Date: June 2001
Study Completion Date: January 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1, A
Group A patients will have a standard dressing applied following initial treatment of their open fracture.
 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.
Experimental: 2, B
Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
 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.
Other Name: Vacuum Assisted Closure (VAC)

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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:

  • Patient who has sustained an open fracture that requires surgical irrigation and debridement.
  • No gross clinical evidence of infection.

Exclusion Criteria:

  • A grossly infected open wound. Infection will be defined by clinical signs and symptoms of infection that include increasing drainage, increasing pain, purulent drainage, and increasing erythema. Any wounds that are thought to be infected will be cultured to confirm the diagnosis.
  • A surgical incision that can not be covered with VAC sponges and a water impermeable sheet (such as Ioban or Tegaderm) to achieve a closed vacuum environment over the wound.
  • Wounds associated with the surgical incision that are intentionally left open to heal with either a delayed primary closure or secondary granulation
  • Abnormal coagulation leading to an expanding hematoma that will require surgical debridement.
  • Pregnant women.
  • Inability or unwillingness to comply with protocol.
  • Patients or family members who are unable or unwilling to sign study informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582361

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: Rena L Stewart, MD The University of Alabama at Birmingham
  More Information

Publications:

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00582361     History of Changes
Other Study ID Numbers: F010316004
Study First Received: December 20, 2007
Results First Received: July 27, 2011
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Open Fractures
Vacuum Assisted Closure (VAC) device
Irrigation and Debridement

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Open
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013