Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries (VAC-ST)
Primary Purpose
Fracture of Calcaneus, Pilon or Tibial Plateau
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Wound Dressing
Vacuum Assisted Closure Device
Sponsored by
About this trial
This is an interventional treatment trial for Fracture of Calcaneus, Pilon or Tibial Plateau focused on measuring Vacuum Assisted Closure (VAC), Calcaneus Fracture, Pilon Fracture, Tibial Plateau Fracture, Open Reduction and Internal Fixation
Eligibility 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
Sites / Locations
- The University of Alabama at Birmingham, Orthopaedic Trauma
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard Wound Dressing
Vacuum Assisted Closure Device
Arm Description
Standard post-operative wound dressing
Vacuum Assisted Closure (VAC) device
Outcomes
Primary Outcome Measures
Healing of Orthopaedic Trauma Extremity Wound Fractures (Calcaneus, Pilon and Tibial Plateau)
Healing of Orthopaedic Trauma Extremity Wounds: Calcaneus, Pilon and Tibial Plateau Fractures with standard dressing versus negative pressure wound therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT00582998
First Posted
December 20, 2007
Last Updated
May 28, 2019
Sponsor
University of Alabama at Birmingham
Collaborators
3M
1. Study Identification
Unique Protocol Identification Number
NCT00582998
Brief Title
Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries
Acronym
VAC-ST
Official Title
Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries Sustained as a Result of Calcaneus, Tibial Plateau and Pilon Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Calcaneus, Pilon or Tibial Plateau
Keywords
Vacuum Assisted Closure (VAC), Calcaneus Fracture, Pilon Fracture, Tibial Plateau Fracture, Open Reduction and Internal Fixation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Wound Dressing
Arm Type
Active Comparator
Arm Description
Standard post-operative wound dressing
Arm Title
Vacuum Assisted Closure Device
Arm Type
Active Comparator
Arm Description
Vacuum Assisted Closure (VAC) device
Intervention Type
Procedure
Intervention Name(s)
Standard Wound Dressing
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Vacuum Assisted Closure Device
Other Intervention Name(s)
Vacuum Assisted Closure (VAC) device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healing of Orthopaedic Trauma Extremity Wound Fractures (Calcaneus, Pilon and Tibial Plateau)
Description
Healing of Orthopaedic Trauma Extremity Wounds: Calcaneus, Pilon and Tibial Plateau Fractures with standard dressing versus negative pressure wound therapy
Time Frame
The time from injury from surgical stabilization (14 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M Theiss, MD
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingham, Orthopaedic Trauma
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18054017
Citation
Tarkin IS, Clare MP, Marcantonio A, Pape HC. An update on the management of high-energy pilon fractures. Injury. 2008 Feb;39(2):142-54. doi: 10.1016/j.injury.2007.07.024. Epub 2007 Dec 3.
Results Reference
background
PubMed Identifier
17967622
Citation
Thompson JT, Marks MW. Negative pressure wound therapy. Clin Plast Surg. 2007 Oct;34(4):673-84. doi: 10.1016/j.cps.2007.07.005.
Results Reference
background
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Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries
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