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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. Identifier: NCT00635479
Recruitment Status : Completed
First Posted : March 13, 2008
Results First Posted : February 14, 2014
Last Update Posted : December 11, 2017
University of California, Davis
University of Alabama at Birmingham
Medical College of Wisconsin
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Pelvic Fractures Acetabular Fractures Hip Fractures Device: VAC device Other: Gauze dressing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic and Acetabular Fractures
Study Start Date : March 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Other Names:
  • Wound Vac
  • Negative pressure wound therapy (NPWT)
  • Incisional Vac

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

Primary Outcome Measures :
  1. Number of Participants With Wound Infections [ Time Frame: Until wound healed, up to 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00635479

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United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
University of California, Davis
University of Alabama at Birmingham
Medical College of Wisconsin
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Principal Investigator: Brett D Crist, MD University of Missouri-Columbia
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Responsible Party: Brett Crist, Assistant Professor, Co-Director of Trauma Services, Co-Director Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia Identifier: NCT00635479    
Other Study ID Numbers: IRB 1096320
First Posted: March 13, 2008    Key Record Dates
Results First Posted: February 14, 2014
Last Update Posted: December 11, 2017
Last Verified: November 2017
Keywords provided by Brett Crist, University of Missouri-Columbia:
Pelvic bones
Hip bones
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries