View Clinical Trial (Medical Research Study)
A Multi-centered Trial of the Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic, Acetabular and Hip Fractures
| City: |
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Columbia |
| State: |
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Missouri |
| Zip Code: |
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65212 |
| Conditions: |
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Pelvic Bone Fractures - Acetabular Fracture - Hip Fractures |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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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
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| NCT ID: |
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NCT00635479 |
| Primary Contact: |
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Principal Investigator
Brett D Crist, MD
University of Missouri-Columbia
Brett D Crist, MD
Phone: 573-882-6562
Email: cristb@health.missouri.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Columbia, Missouri 65212
United States
Brett D. Crist, MD
Phone: 573-882-6562
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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