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

NCT00635479 | Completed Results

• 2 other identifiers: IRB 10963201138438
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Fractures; Acetabular Fractures; Hip Fractures

Keywords

Fractures; Pelvic bones; Acetabulum; Hip bones

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Wound Infections

  Until wound healed, up to 1 year

Study Arms (2)

VAC Device placement

EXPERIMENTAL

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

Device: VAC device

Gauze dressing

ACTIVE COMPARATOR

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

Other: Gauze dressing

Interventions

VAC device DEVICE

Vacuum Assisted Closure (VAC) device for surgical incision

Also known as: Wound Vac, Negative pressure wound therapy (NPWT), Incisional Vac

VAC Device placement

Gauze dressing OTHER

Gauze dressing for surgical incision

Gauze dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Scheduled for surgical repair of pelvic and/or acetabular fracture
• Subject/guardian able to provide informed consent

You may not qualify if:

• Less than 18 years of age
• Subject/guardian unable to provide informed consent

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• University of California, Davis: collaborator
• University of Alabama at Birmingham: collaborator
• Medical College of Wisconsin: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Hip Fractures; Fractures, Bone

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Results Point of Contact

• Title: Brett Crist, MD
• Organization: University of Missouri, Department of Orthopaedics

cristb@health.missouri.edu

573-882-6562

Study Officials

• Brett D Crist, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Co-Director of Trauma Services, Co-Director Trauma Fellowship, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 13, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 11, 2017
• Results First Posted: February 14, 2014

Record last verified: 2017-11

Locations

US (1)