About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Accelerated Flap Coverage Surgery
- Standard of Care Flap Timing
Treatment groups
Sponsors and collaborators
Johns Hopkins University
Lead sponsor
McMaster University
Collaborator
University of Maryland, Baltimore
Collaborator
Orthopaedic Trauma Association
Collaborator
Foundation of Orthopedic Trauma
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator