Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic and Acetabular Fractures
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.
Device: VAC device
Other: Gauze dressing
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic and Acetabular Fractures|
- Wound Infections [ Time Frame: until wound healed ] [ Designated as safety issue: No ]
- Wound Drainage [ Time Frame: until wound healed ] [ Designated as safety issue: No ]
- Hospital Length of Stay [ Time Frame: until discharge from acute care ] [ Designated as safety issue: No ]
- Dressing Supply Costs [ Time Frame: until wound healed ] [ Designated as safety issue: No ]
- Nursing Time Cost for Dressing Changes [ Time Frame: until wound is healed ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||December 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: VAC Device placement
will have the VAC device used for post-operative management of acetabular fractures and pelvic fractures.
Device: VAC device
Vacuum Assisted Closure (VAC) device for surgical incision
Active Comparator: Gauze dressing
will receive current traditional surgical wound management with daily dressing changes in post operative management of acetabular fractures and pelvic fractures.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635479
|United States, Missouri|
|University of Missouri|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Brett D Crist, MD||University of Missouri-Columbia|