Accelerated Flap Coverage in Severe Lower Extremity Trauma
Recruiting now · Not applicable
Conditions studied: Open Tibia Fracture, Open Dislocation of Ankle, Extremity Fracture Lower, Extremity Injuries Lower
In brief
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).
Key facts
- Study ID
- NCT06293469
- Run by
- Johns Hopkins University
- People needed
- 356
- Starts
- 2024-11-04
- Expected to finish
- 2030-02-01
- Last updated by the study team
- 2025-10-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UC Davis Medical Center — Sacramento, California, United States (enrolling)
- R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States (enrolling)
- John Hopkins Bayview Medical Center — Baltimore, Maryland, United States (enrolling)
- The Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
- University of Maryland Capital Region Medical Center — Largo, Maryland, United States (enrolling)
- Oregon Health & Science University — Portland, Oregon, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
- Vall d'Hebron University Hospital — Barcelona, Spain (enrolling)
Full record on ClinicalTrials.gov
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