Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: August 5, 2013
Last verified: May 2012

December 20, 2007
August 5, 2013
June 2001
September 2008   (final data collection date for primary outcome measure)
  • Healing of Orthopaedic Trauma Open Fractures [ Time Frame: from surgery to wound closure ] [ Designated as safety issue: No ]
    Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)
  • Infections [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Number of acute, delayed and deep wound infections.
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 ]
Complete list of historical versions of study NCT00582361 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Vacuum Assisted Closure as a Treatment for Open Fractures
Vacuum Assisted Closure as a Treatment for Open Fractures

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.

Soft tissue injury following an open fracture is a significant problem following surgical treatment of traumatic skeletal injuries. The soft tissue injury results from a combination of the initiating trauma and additional tissue injury during surgery. Current treatment includes open reduction and internal fixation versus external fixation, irrigation and debridement following admission, decreased activity (non weight bearing status on the injured extremity), maintaining the patient as an inpatient in the hospital, repeated irrigation and debridements (36-72 hours following the initial trauma) with concomitant wound culturing until which time it is determined that either delayed primary closure, or skin grafting with/without flap coverage should be attempted.

All patients in the study will be treated with the appropriate empiric antibiotic regimen until wound culture results justify modification for antibiotic sensitivity/resistance reasons. In general, barring patient allergy, the empiric antibiotic regimen will adhere to the Gustilo and Anderson classification as follows:

Grade I : Ancef Grade II : Ancef and Gentamicin or Zosyn Grade III : Ancef, Gentamicin or Zosyn, and add a Penicillin for grade IIIB open fractures.

All wounds will be assessed initially at admission following the Gustilo and Anderson classification for open fractures. Subsequent wound assessments in the operating room will be graded according to the following descriptive scale:

Type A wound: Abundant granulation tissue, ready for closure. Type B Wound: Granulation tissue present but inadequate for closure, Wound is clinically clean appearing. Type C Wound: No granulation tissue, no gross purulence. Type D Wound: Gross purulence/infected wound, no granulation tissue.

The outcome variables consist of the intraoperative and postoperative adverse device effects recorded in the medical record and on the study data collection form, time to wound closure, intraoperative and postoperative complications recorded in medical record and on the study data collection form. Clinical photographs of the wounds will be taken with a digital camera at the time of admission to the study, and during each subsequent trip to the operating room (every 48-72 hours). We will also record the injury severity score for all multiple trauma patients recorded at the time of injury in the medical record and on the study data collection form, and soft tissue score according to Gustillo and Anderson for open injuries in the medical record and on the study data collection form. Baseline serum albumin and total lymphocyte counts will be taken on admission to evaluate baseline nutritional and immunologic status at the time of injury. All patients in the Intensive Care Units will have daily weights, fluid balances, and nutritional intake documented. Resuscitation data will also be recorded from the trauma room, including fluids, blood, and base deficit. The effects will be measured by clinical examination and will be augmented with culture data for any wounds that require surgical intervention.

Patients who have an open fracture and who give informed consent to enter the study will be randomized into two groups. Group A will be patients treated with a 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 which time the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage. Group B will be patients treated with a VAC negative pressure device following the initial surgical irrigation and debridement. Group B patients will return to the operating room approximately 48 hours following the initial irrigation and debridement for VAC removal, wound cultures (qualitative and quantitative), repeat irrigation and debridement, and wound evaluation by the surgeon for possible delayed closure versus reapplication of the VAC device. Group B patients will also be returned to the operating room approximately every 48 hours thereafter for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until the wound is judged ready for coverage or closure by the surgeon.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Orthopaedic Traumatic Open Fractures
  • 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.
    Other Name: Vacuum Assisted Closure (VAC)
  • Active Comparator: 1, A
    Group A patients will have a standard dressing applied following initial treatment of their open fracture.
    Intervention: Procedure: Standard Wound Dressing
  • Experimental: 2, B
    Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
    Intervention: Device: VAC

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
January 2010
September 2008   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582361
F010316004
No
University of Alabama at Birmingham
University of Alabama at Birmingham
KCI USA, Inc.
Principal Investigator: Rena L Stewart, MD The University of Alabama at Birmingham
University of Alabama at Birmingham
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP