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

• ClinicalTrials.gov Identifier: NCT00635479
• Recruitment Status: Completed
• First Posted: March 13, 2008
• Results First Posted: February 14, 2014
• Last Update Posted: December 11, 2017
• Sponsor: University of Missouri-Columbia
• 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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• 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
• First Posted: March 13, 2008
• 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:

Fractures; Pelvic bones; Acetabulum; Hip bones

Additional relevant MeSH terms:

Fractures, Bone; Hip Fractures; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries