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Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic and Acetabular Fractures

Primary Purpose

Pelvic Fractures, Acetabular Fractures, Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VAC device
Gauze dressing
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Fractures focused on measuring Fractures, Pelvic bones, Acetabulum, Hip bones

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • Scheduled for surgical repair of pelvic and/or acetabular fracture
  • Subject/guardian able to provide informed consent

Exclusion Criteria:

  • Less than 18 years of age
  • Subject/guardian unable to provide informed consent

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VAC Device placement

Gauze dressing

Arm Description

will have the VAC device used for post-operative management of acetabular fractures and pelvic fractures.

will receive current traditional surgical wound management with daily dressing changes in post operative management of acetabular fractures and pelvic fractures.

Outcomes

Primary Outcome Measures

Number of Participants With Wound Infections

Secondary Outcome Measures

Full Information

First Posted
March 6, 2008
Last Updated
November 8, 2017
Sponsor
University of Missouri-Columbia
Collaborators
University of California, Davis, University of Alabama at Birmingham, Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT00635479
Brief Title
Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic and Acetabular Fractures
Official Title
Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic and Acetabular Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
University of California, Davis, University of Alabama at Birmingham, Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to study the efficacy and cost effectiveness of the VAC device in comparison to traditional gauze wound dressing in pelvic, acetabular and hip fractures, specifically to see if there is a reduction in the incidence of post operative surgical wound drainage, infections, and hospital stay.
Detailed Description
Soft tissue injuries are commonly associated with pelvic and acetabular injuries and additional tissue injury occurs during surgery. Post operative wound drainage, infections and prolonged hospital stay are a common problem during postoperative care. Traditional treatment is dressing of the surgical wound with different conventional dressings. Use of negative pressure wound therapy has been shown to be beneficial in significantly decreasing wound drainage. Stannard et al. reported the results of randomizing 44 patients with lower extremity fractures (including 4 pilon fractures) into either receiving standard post operative dressing versus NPWT (negative pressure wound therapy). His results showed no difference in infection rate or wound breakdown, but did show a significant difference in the drainage time. The NPWT group stopped draining 3 days earlier than the standard dressing group. The use of NPWT has greatly increased over the years and has been an important adjunct to wound management. These results and anecdotal clinical experience with the use of NPWT (wound VAC) has led us to develop our research question; Does the use of incisional VAC following pelvic &/or acetabular surgery decrease wound complications. The VAC (KCI USA) device is relatively new device that utilizes negative pressure as a treatment modality for soft tissue injuries following high velocity injuries. VAC device exerts intermittent or constant negative pressure and removes excess fluid from the interstitial space and increases perfusion through vessels. Previous VAC studies showed decreased bacterial load after applying VAC device to the infected wounds. There have been no randomized studies to prove the cost effectiveness and efficacy of VAC device in reducing wound drainage, infections, and prolonged hospital stays in comparison to traditional gauze dressing wound management during post operative management of pelvic and acetabular fractures. In examining the incidence of wound complications/infections, we can determine if the incisional VAC decreases the need for additional intervention and if there are any patient related factors (i.e. obesity) related to increased risk of wound complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Fractures, Acetabular Fractures, Hip Fractures
Keywords
Fractures, Pelvic bones, Acetabulum, Hip bones

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VAC Device placement
Arm Type
Experimental
Arm Description
will have the VAC device used for post-operative management of acetabular fractures and pelvic fractures.
Arm Title
Gauze dressing
Arm Type
Active Comparator
Arm Description
will receive current traditional surgical wound management with daily dressing changes in post operative management of acetabular fractures and pelvic fractures.
Intervention Type
Device
Intervention Name(s)
VAC device
Other Intervention Name(s)
Wound Vac, Negative pressure wound therapy (NPWT), Incisional Vac
Intervention Description
Vacuum Assisted Closure (VAC) device for surgical incision
Intervention Type
Other
Intervention Name(s)
Gauze dressing
Intervention Description
Gauze dressing for surgical incision
Primary Outcome Measure Information:
Title
Number of Participants With Wound Infections
Time Frame
Until wound healed, up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Scheduled for surgical repair of pelvic and/or acetabular fracture Subject/guardian able to provide informed consent Exclusion Criteria: Less than 18 years of age Subject/guardian unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett D Crist, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic and Acetabular Fractures

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