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

This study has been completed.
Sponsor:
Collaborators:
University of California, Davis
University of Alabama at Birmingham
Medical College of Wisconsin
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00635479
First received: March 6, 2008
Last updated: February 28, 2014
Last verified: February 2014
  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 Fractures
Acetabular Fractures
Hip Fractures
Device: VAC device
Other: Gauze dressing

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Wound Infections [ Time Frame: until wound healed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 115
Study Start Date: March 2008
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635479

Locations
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
Investigators
Principal Investigator: Brett D Crist, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Brett Crist, Assistant Professor, Co-Director of Trauma Services, Co-Director Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00635479     History of Changes
Other Study ID Numbers: IRB 1096320, 1138438
Study First Received: March 6, 2008
Results First Received: January 1, 2014
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Fractures
Pelvic bones
Acetabulum
Hip bones

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 15, 2014