Vacuum Assisted Closure as a Treatment for Open Fractures - Full Text View

Sponsors and Collaborators:	University of Alabama at Birmingham KCI USA, Inc.
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00582361

Purpose

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.

Condition	Intervention
Orthopaedic Traumatic Open Fractures	Procedure: Standard Wound Dressing Device: VAC

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Vacuum Assisted Closure as a Treatment for Open Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures Injuries Wounds

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Healing of Orthopaedic Trauma Open Fractures [ Time Frame: Initial Treatment : 2-3 days; Postoperative: 0-5 days; Follow-up: 12 months ] [ Designated as safety issue: No ]

Enrollment:	63
Study Start Date:	June 2001
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1, A: Active Comparator Group A patients will have a standard dressing applied following initial treatment of their open fracture.	Procedure: Standard Wound Dressing 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.
2, B: Experimental Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.	Device: VAC 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.

Arms

Assigned Interventions

1, A: Active Comparator

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

Procedure: Standard Wound Dressing

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.

2, B: Experimental

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

Device: VAC

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.

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Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582361

Locations

United States, Alabama
The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

KCI USA, Inc.

Investigators

Principal Investigator:

James P Stannard, MD

The University of Alabama at Birmingham

More Information

Publications:

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.

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. German.

Responsible Party:	The University of Alabama at Birmingham ( James P. Stannard, MD, Professor of Surgery, Assoc. Director of Orthopaedic Surgery )
Study ID Numbers:	F010316004, VAC2001-06
Study First Received:	December 20, 2007
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00582361 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

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

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Fractures, Open

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Fractures, Open

ClinicalTrials.gov processed this record on September 10, 2009