Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic and Acetabular Fractures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00635479|
Recruitment Status : Completed
First Posted : March 13, 2008
Results First Posted : February 14, 2014
Last Update Posted : December 11, 2017
|Condition or disease||Intervention/treatment|
|Pelvic Fractures Acetabular Fractures Hip Fractures||Device: VAC device Other: Gauze dressing|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic and Acetabular Fractures|
|Study Start Date :||March 2008|
|Primary Completion Date :||September 2013|
|Study Completion Date :||December 2013|
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
- Number of Participants With Wound Infections [ Time Frame: Until wound healed, up to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635479
|United States, Missouri|
|University of Missouri|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Brett D Crist, MD||University of Missouri-Columbia|