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| Sponsors and Collaborators: |
University of Missouri-Columbia University of California, Davis University of Alabama at Birmingham Medical College of Wisconsin |
|---|---|
| Information provided by: | University of Missouri-Columbia |
| ClinicalTrials.gov Identifier: | NCT00635479 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pelvic Bone Fractures Acetabular Fractures Hip Fractures |
Device: Wound Vac Other: Gauze dressing |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | A Multi-Centered Trial of the Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic, Acetabular and Hip Fractures |
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Vacuum Assisted Closure (VAC) device
|
Device: Wound Vac
Vacuum Assisted Closure (VAC) device for surgical incision
|
|
2: Experimental
Gauze Dressing
|
Other: Gauze dressing
Gauze dressing for surgical incision
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Brett D Crist, MD | 573-882-6562 | cristb@health.missouri.edu |
| Contact: Linda K Anderson, BSN | 573-884-0854 | andersonlk@health.missouri.edu |
| United States, Alabama | |
| University of Alabama at Birmingham | Not yet recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: James Stannard, MD 205-975-2663 | |
| Principal Investigator: James Stannard, MD | |
| United States, California | |
| Universtiy of California - Davis | Not yet recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Tania Ferguson, MD 916-734-2700 | |
| Principal Investigator: Tania Ferguson, MD | |
| United States, Missouri | |
| University of Missouri | Recruiting |
| Columbia, Missouri, United States, 65212 | |
| Contact: Linda Anderson, BSN 573-884-0854 andersonlk@health.missouri.edu | |
| Principal Investigator: Brett D Crist, MD | |
| Sub-Investigator: Gregory Della Rocca, MD | |
| Sub-Investigator: Yvonne Murtha, MD | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Jason Roberts, MD 414-805-7410 | |
| Principal Investigator: Jason Roberts, MD | |
| Principal Investigator: | Brett D Crist, MD | University of Missouri-Columbia |
More Information
| Responsible Party: | University of Missouri ( Brett Crist, MD ) |
| Study ID Numbers: | IRB 1096320, IRB 1138438 |
| Study First Received: | March 6, 2008 |
| Last Updated: | June 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00635479 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Fractures Pelvic bones Acetabulum Hip bones |
|
Hip Fractures Femoral Fractures Fractures, Bone |
Wounds and Injuries Disorders of Environmental Origin Leg Injuries |
|
Hip Fractures Femoral Fractures Fractures, Bone Wounds and Injuries |
Disorders of Environmental Origin Leg Injuries Hip Injuries |
