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

This study has been completed.
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 18, 2013
Last verified: September 2013

December 20, 2007
September 18, 2013
June 2001
March 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00582998 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries
Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries Sustained as a Result of Calcaneus, Tibial Plateau and Pilon Fractures

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.

Patients who have a calcaneus fracture requiring open reduction and internal fixation through a lateral approach and who give informed consent to enter the study will be randomized into two groups. Randomization will be stratified for each of the three fracture types. Group A will be patients treated with daily dressing changes and wound evaluations beginning on post operative day 1. Group B patients will have a VAC device placed in the operating room, with the first post-operative wound evaluation taking place 48 hours post-op. If at the first post-operative evaluation there is marked drainage, the VAC device will be replaced with re-evaluation approximately 48 hours later.

The outcome variables consist of the number of days and amount of wound drainage, incidence of wound breakdown, incidence of flap coverage, incidence of infection, return to the operating room for repeat irrigation and debridement , the need for repeat wound closure, and any other intraoperative and postoperative complications recorded in medical record and on the study data collection form.

Patients who have a tibial plateau fracture requiring open reduction and internal fixation and who give informed consent to enter the study will be randomized into two groups. Group A will be patients treated with daily dressing changes and wound evaluations beginning on post operative day 2. Group B patients will have a VAC device placed in the operating room, with the first post-operative wound evaluation taking place 48 hours post-op. If at the first post-operative evaluation there is marked drainage the VAC device will be replaced with re-evaluation approximately 48 hours later. Patients with open tibial plateau fractures will be included in both groups A and B but will be sub-stratified within each group.

The outcome variables consist of the number of days and amount of wound drainage, incidence of wound breakdown, incidence of flap coverage, incidence of infection, return to the operating room for repeat irrigation and debridement , the need for repeat wound closure, and any other intraoperative and postoperative complications recorded in medical record and on the study data collection form.

Patients who have a pilon fracture requiring open reduction and internal fixation and who give informed consent to enter the study will be randomized into two groups. Group A will be patients treated with daily dressing changes and wound evaluations beginning on post operative day 2. Group B patients will have a VAC device placed in the operating room, with the first post-operative wound evaluation taking place 48 hours post-op. If at the first post-operative evaluation there is marked drainage the VAC device will be replaced with re-evaluation approximately 48 hours later. Patients with open pilon fractures will be included in both groups A and B but will be sub-stratified within each group.

The outcome variables consist of the number of days and amount of wound drainage, incidence of wound dehiscence, incidence of flap coverage, incidence of infection, return to the operating room for repeat irrigation and debridement, the need for repeat wound closure, and any other intraoperative and postoperative complications recorded in medical record and on the study data collection form. All patients will have their total lymphocyte counts and their albumin levels recorded on admission to document their nutritional status and ability to heal wounds.

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. 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. The soft tissue score, according to the Tscherne classification for closed injuries or according to the Gustillo and Anderson classification for open injuries will also be recorded, for all multiple trauma patients, at the time of injury in the medical record and on the study data collection form. The effects will be measured by clinical examination and will be augmented with culture data for any wounds that require surgical intervention. All patients in the Intensive Care Units will have daily weights, fluid balances, and nutritional intake recorded per ICU protocol. Resuscitation data, including total fluids, blood products, and base deficit will be recorded. Fluids and blood utilization in the OR will also be documented.

The following methods and tools will be used to document study data points: intraoperative and postoperative adverse device effects recorded in the medical record and on the study data collection form, daily wound drainage as documented on rounds and in the medical record, admission total lymphocyte count and serum albumin levels, clinical evidence of infection and supplementary lab data. All of this data will be documented on the study data collection form. Patients will be followed clinically for 12 months, documenting any complications that occur with the wound (infection, dehiscence, etc…) on the study data collection form. The soft tissue score according to Tscherne classification for closed injuries, and the Gustillo and Anderson score for open injuries, will be recorded in the medical record and on the study data collection form.

Data will be collected and entered into EXCEL spreadsheets with double keying for quality control purposes and managed by the Department of Orthopaedic Surgery at the University of Alabama at Birmingham (UAB). After data entry is complete, the file(s) will be copied to diskette and delivered to the UAB Biostatistics statistician for analysis and report generation. The analysis will involve simple descriptive statistics (means, standard deviations, proportions) to assure balance of the treatment groups with respect to relevant variables. T-test will be used to compare the mean times to wound closure as well as the need for surgical debridement of the wound. Analysis of covariance will be performed if there are variables that require adjustment. Growth curve analysis (survival models) and Cox regression procedures will be used to compare the rates of wound closure between the two groups. Assumption of proportional hazards in the model will be verified before attempting Cox regression procedures. P-values will be computed using a Mann-Whitney U test for non-parametric data.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fracture of Calcaneus, Pilon or Tibial Plateau
  • 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.
  • 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
  • Active Comparator: 1, A
    Standard post-operative wound dressing
    Intervention: Procedure: Standard Wound Dressing
  • Active Comparator: 2, B
    Vacuum Assisted Closure (VAC) device
    Intervention: Device: VAC

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
189
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582998
F010316003
No
Taylor W. Vlack, University of Alabama at Birmingham
University of Alabama at Birmingham
KCI USA, Inc.
Principal Investigator: David A Volgas, MD The University of Alabama at Birmingham
University of Alabama at Birmingham
September 2013

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