Accelerated Flap Coverage in Severe Lower Extremity Trauma
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).
- EligibilityCriteria: The inclusion criteria are:  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 musculoskeletal injury surgeries performed by a participating surgeon or delegate. Able to be randomized within 48 hours of injury. Site anticipates being able to implement the accelerated flap protocol due to temporary local logistics.  The exclusion criteria are:  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. Burns at the musculoskeletal injury site. Incarceration. Currently enrolled in a trial that does not permit co-enrollment. Declined to provide informed consent. Unable to obtain informed consent due to language barriers. Unable to obtain informed consent because a legally authorized representative was unavailable. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient. Prior enrollment in the trial. Other reason to exclude the patient, as approved by the Methods Centre. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult