Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries

NCT ID: NCT00582998

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2007-03-31

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.

Conditions

Fracture of Calcaneus, Pilon or Tibial Plateau

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Wound Dressing

Standard post-operative wound dressing

Group Type: ACTIVE_COMPARATOR

Standard Wound Dressing

Intervention Type: PROCEDURE

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.

Vacuum Assisted Closure Device

Vacuum Assisted Closure (VAC) device

Group Type: ACTIVE_COMPARATOR

Vacuum Assisted Closure Device

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: PROCEDURE

Vacuum Assisted Closure Device

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.

Intervention Type: DEVICE

Other Intervention Names

Vacuum Assisted Closure (VAC) device

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCI USA, Inc

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Steven Theiss, MD

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven M Theiss, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Locations

The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18054017 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17967622 (View on PubMed)

Other Identifiers

F010316003

Identifier Type: -

Identifier Source: org_study_id