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Accelerated Flap Coverage in Severe Lower Extremity Trauma

Sponsor: Johns Hopkins University • ClinicalTrials.gov ID: NCT06293469

Registry updated: 2026-09-18

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Description

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 vanguard and international part of the FLAP ATTACK trial.

Interventions

Accelerated Flap Coverage Surgery (Procedure)
Timing of the flap surgery is with a goal of 72 hours from injury
Standard of Care Flap Timing (Procedure)
Timing of the flap surgery is the standard of care flap timing for the participating institution.

Eligibility criteria

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.

Conditions

Open Tibia Fracture Open Dislocation of Ankle Extremity Fracture Lower Extremity Injuries Lower

Locations

UC Davis Medical Center — Sacramento, California, United States
R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
John Hopkins Bayview Medical Center — Baltimore, Maryland, United States
The Johns Hopkins Hospital — Baltimore, Maryland, United States
University of Maryland Capital Region Medical Center — Largo, Maryland, United States
Oregon Health & Science University — Portland, Oregon, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
The Alfred Hospital — Melbourne, Victoria, Australia
Vancouver General Hospital — Vancouver, British Columbia, Canada
Saint John Regional Hospital — Saint John, New Brunswick, Canada
Vall d'Hebron University Hospital — Barcelona, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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