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Accelerated Flap Coverage in Severe Lower Extremity Trauma
Sponsor: Johns Hopkins University
Summary
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).
Official title: Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
356
Start Date
2024-11-04
Completion Date
2030-02
Last Updated
2025-10-14
Healthy Volunteers
No
Conditions
Interventions
Accelerated Flap Coverage Surgery
Timing of the flap surgery is with a goal of 72 hours from injury
Standard of Care Flap Timing
Timing of the flap surgery is the standard of care flap timing for the participating institution.
Locations (9)
UC Davis Medical Center
Sacramento, California, United States
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
John Hopkins Bayview Medical Center
Baltimore, Maryland, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Maryland Capital Region Medical Center
Largo, Maryland, United States
Oregon Health & Science University
Portland, Oregon, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The Alfred Hospital
Melbourne, Victoria, Australia
Vall d'Hebron University Hospital
Barcelona, Spain