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Accelerated Flap Coverage in Severe Lower Extremity Trauma

RecruitingNAAges 18 Years - anyAllJohns Hopkins University
NCT06293469 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility). This is the vanguar

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📋 Eligibility rules (as published)
The inclusion criteria are: 1. Patients 18 years of age or older. 2. Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury. 3. Will have all planned flap surgeries performed by a participating surgeon or delegate. 4. Able to be randomized within 48 hours of injury. The exclusion criteria are: 1. Site is unable to implement the accelerated flap protocol due to local logistics. 2. Primary amputation anticipated prior to attempted flap for management of the injury. 3. Critical limb ischemia that requires re-vascularization for limb perfusion. 4. Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery. 5. Burns at the musculoskeletal injury site. 6. Incarceration. 7. Expected injury survival of less than 12 months. 8. Terminal illness with expected survival of less than 12 months. 9. Currently enrolled in a trial that does not permit co-enrollment. 10. Declined to provide informed consent. 11. Unable to obtain informed consent due to language barriers. 12. Unable to obtain informed consent because a legally authorized representative was unavailable. 13. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient. 14. Prior enrollment in the trial. 15. Eligible patient or LAR was not approached within screening window (missed participant). 16. Other reason to exclude the patient, as approved by the Principal Investigators.
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What it tests

  • Accelerated Flap Coverage Surgery
  • Standard of Care Flap Timing
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Where

11 sites
UC Davis Medical Center
Sacramento, United States
R Adams Cowley Shock Trauma Center
Baltimore, United States
John Hopkins Bayview Medical Center
Baltimore, United States
The Johns Hopkins Hospital
Baltimore, United States
University of Maryland Capital Region Medical Center
Largo, United States
Oregon Health & Science University
Portland, United States
Vanderbilt University Medical Center
Nashville, United States
The Alfred Hospital
Melbourne, Australia

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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