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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635479
• Other study ID #: IRB 1096320
• Secondary ID: 1138438
• Status: Completed
• Phase: N/A
• First received: March 6, 2008
• Last updated: November 8, 2017
• Start date: March 2008
• Est. completion date: December 2013

Study information

• Verified date: November 2017
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acetabular Fractures
• Fractures, Bone
• Hip Fractures
• Pelvic Fractures

Intervention

Device:
• VAC device
Vacuum Assisted Closure (VAC) device for surgical incision

Other:
• Gauze dressing
Gauze dressing for surgical incision

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Medical College of Wisconsin, University of Alabama at Birmingham, University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Wound Infections		Until wound healed, up to 1 year