Vacuum Assisted Closure as a Treatment for Open Fractures
Completed · Not applicable
Conditions studied: Orthopaedic Traumatic Open Fractures
In brief
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.
Key facts
- Study ID
- NCT00582361
- Run by
- University of Alabama at Birmingham
- People needed
- 63
- Starts
- 2001-06-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2013-08-14
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- The University of Alabama at Birmingham, Orthopaedic Trauma — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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