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.
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.
Will have all planned flap surgeries performed by a participating surgeon or delegate.
Able to be randomized within 48 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/SurgeryTiming of the flap surgery is with a goal of 72 hours from injury
Standard of Care Flap Timing
Procedure/SurgeryTiming of the flap surgery is the standard of care flap timing for the participating institution.
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) 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 major flap complication will account for more than one operation, assuming that more operations are worse.
Number of days in hospital
Days in an acute in-patient hospital (i.e., not rehab or nursing facility)
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
McMaster University
Collaborator
University of Maryland, Baltimore
Collaborator
Orthopaedic Trauma Association
Collaborator
Foundation of Orthopedic Trauma
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
