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

NCT ID: NCT00635479

Last Updated: 2017-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2013-12-31

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.

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.

Conditions

Pelvic Fractures; Acetabular Fractures; Hip Fractures

Keywords

Fractures; Pelvic bones; Acetabulum; Hip bones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VAC Device placement

will have the VAC device used for post-operative management of acetabular fractures and pelvic fractures.

Group Type: EXPERIMENTAL

VAC device

Intervention Type: DEVICE

Vacuum Assisted Closure (VAC) device for surgical incision

Gauze dressing

will receive current traditional surgical wound management with daily dressing changes in post operative management of acetabular fractures and pelvic fractures.

Group Type: ACTIVE_COMPARATOR

Gauze dressing

Intervention Type: OTHER

Gauze dressing for surgical incision

Interventions

VAC device

Vacuum Assisted Closure (VAC) device for surgical incision

Intervention Type: DEVICE

Gauze dressing

Gauze dressing for surgical incision

Intervention Type: OTHER

Other Intervention Names

Wound Vac; Negative pressure wound therapy (NPWT); Incisional Vac

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Brett Crist

Assistant Professor, Co-Director of Trauma Services, Co-Director Trauma Fellowship, Department of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brett D Crist, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri

Columbia, Missouri, United States

Countries

United States

Other Identifiers

1138438

Identifier Type: -

Identifier Source: secondary_id

IRB 1096320

Identifier Type: -

Identifier Source: org_study_id