Johns Hopkins University
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).
Infection following severe lower extremity musculoskeletal injuries is a challenging problem. Several factors hypothesized to influence infection have been explored and, in many cases, optimized or found not to be influential. A persistent area of uncertainty and variability is the timing of acute soft tissue coverage. In the United States, the mean time to coverage from injury is 10 days, and infection rates are 20-35%. In the United Kingdom, there are national guidelines to support coverage within 72 hours of injury, and infection rates are less than 10%. While the data to support early cove…
Inclusion Criteria: * 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. Exclusion Criteria: * 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…
Activation of the accelerated flap pathway with a goal flap time of \<72h from injury
Flap timing at the standard of care timing for the clinical site