Open fracture Severe Lower Extremity Musculoskeletal Injuries
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patients 16 years of age or older. 2) Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury. 3) Will have all planned flap surgeries performed by a participating surgeon or delegate. 4) Able to be randomized within 48 hours of injury.
Exclusion criteria
Exclusion criteria: 1) Site is unable to implement the accelerated flap protocol due to local logistics. 2) Primary amputation anticipated prior to attempted flap for management of the injury. 3) Critical limb ischemia that requires re-vascularization for limb perfusion. 4) Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery. 5) Burns at the musculoskeletal injury site. 6) Incarceration. 7) Currently enrolled in a trial that does not permit co-enrollment. 8) Declined to provide informed consent. 9) Unable to obtain informed consent due to language barriers. 10) Unable to obtain informed consent because a legally authorized representative was unavailable. 11) Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient. 12) Prior enrollment in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pilot study primary outcome: Number of patients that we can recruit within a one-year timeframe. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pilot study secondary outcomes: 1) Patient reported function, satisfaction and quality of life 2) Medical costs and productivity loss. 3) Injury-related amputation of the lower extremity; 4) Unplanned reoperations to manage infection, flap compromise, or flap loss; 5) Days in the hospital; 6) Mortality; 7) loss to follow-up | — |
Countries
Netherlands
Outcome results
None listed