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).
Patients 18 years of age or older.
Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury.
Treating surgeon is willing to comply with treatment allocation.
Able to be randomized within 72 hours of injury.
Site is unable to implement the accelerated flap protocol due to local logistics.
Primary amputation anticipated prior to attempted flap for management of the injury.
Critical limb ischemia that requires re-vascularization for limb perfusion.
Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery.
Parallel
Accelerated Flap Coverage Surgery
Procedure/SurgeryActivation of the accelerated flap pathway with a goal flap time of \<72h from injury
Standard of Care Flap Timing
Procedure/SurgeryFlap timing at the standard of care timing for the clinical site
Clinical Status
Clinical status is a hierarchical composite of the following outcomes: 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)
Mortality
All-cause mortality. Mortality will be time-to-event, with the assumption that earlier is worse than later.
Amputation
Amputation related to injury. Amputation will be time-to-event, with the assumption that earlier is worse than later.
Unplanned re-operation
Unplanned re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure). Re-operation for infection and flap complication will account for more than one operation, with the assumption that more is worse than less.
Number of days in hospital
Days in an acute in-patient hospital (i.e., not rehab or nursing facility)
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Johns Hopkins University
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
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