Vacuum Assisted Closure as a Treatment for Open Fractures

NCT00582361 | Completed Results

• 1 other identifier: F010316004
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This project is designed as a prospective, randomized, comparative study evaluating the use of a negative pressure vacuum device in treating traumatic wounds sustained associated with an open fracture.

Conditions

Orthopaedic Traumatic Open Fractures

Keywords

Open Fractures; Vacuum Assisted Closure (VAC) device; Irrigation and Debridement

Outcome Measures

Primary Outcomes (2)

• Healing of Orthopaedic Trauma Open Fractures

  Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)

  from surgery to wound closure

• Infections

  Number of acute, delayed and deep wound infections.

  Up to 12 months

Study Arms (2)

1, A

ACTIVE COMPARATOR

Group A patients will have a standard dressing applied following initial treatment of their open fracture.

Procedure: Standard Wound Dressing

2, B

EXPERIMENTAL

Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.

Device: VAC

Interventions

Standard Wound Dressing PROCEDURE

Group A patients will have a standard dressing applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.

1, A

VAC DEVICE

Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.

Also known as: Vacuum Assisted Closure (VAC)

2, B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who has sustained an open fracture that requires surgical irrigation and debridement.
• No gross clinical evidence of infection.

You may not qualify if:

• A grossly infected open wound. Infection will be defined by clinical signs and symptoms of infection that include increasing drainage, increasing pain, purulent drainage, and increasing erythema. Any wounds that are thought to be infected will be cultured to confirm the diagnosis.
• A surgical incision that can not be covered with VAC sponges and a water impermeable sheet (such as Ioban or Tegaderm) to achieve a closed vacuum environment over the wound.
• Wounds associated with the surgical incision that are intentionally left open to heal with either a delayed primary closure or secondary granulation
• Abnormal coagulation leading to an expanding hematoma that will require surgical debridement.
• Pregnant women.
• Inability or unwillingness to comply with protocol.
• Patients or family members who are unable or unwilling to sign study informed consent.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• KCI USA, Inc: collaborator

Study Sites (1)

The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

• Parrett BM, Matros E, Pribaz JJ, Orgill DP. Lower extremity trauma: trends in the management of soft-tissue reconstruction of open tibia-fibula fractures. Plast Reconstr Surg. 2006 Apr;117(4):1315-22; discussion 1323-4. doi: 10.1097/01.prs.0000204959.18136.36.

  PMID: 16582806 BACKGROUND

• Steiert AE, Partenheimer A, Schreiber T, Muehlberger T, Krettek C, Lahoda LU, Vogt PM. [The V.A.C. system (vacuum assisted closure) as bridging between primary osteosynthesis in conjunction with functional reconstructed of soft tissue--open fractures type 2 and type 3]. Zentralbl Chir. 2004 May;129 Suppl 1:S98-100. doi: 10.1055/s-2004-822658. German.

  PMID: 15168301 BACKGROUND

MeSH Terms

Conditions

Fractures, Open

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

None Noted.

Results Point of Contact

• Title: Research Nurse Coordinator
• Organization: UAB

Talyor.vlack@ortho.uab.edu

205-996-6781

Study Officials

• Rena L Stewart, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 28, 2007
• Study Start: June 1, 2001
• Primary Completion: September 1, 2008
• Study Completion: January 1, 2010
• Last Updated: August 14, 2013
• Results First Posted: January 24, 2013

Record last verified: 2012-05

Locations

US (1)