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Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
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).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
356
Start Date
2027-01-01
Completion Date
2030-12
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
Accelerated Flap Coverage Surgery
Activation of the accelerated flap pathway with a goal flap time of \<72h from injury
Standard of Care Flap Timing
Flap timing at the standard of care timing for the clinical site
Locations (31)
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
Keck Hospital of USC
Los Angeles, California, United States
Los Angeles Medical Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
UC San Diego Health
San Diego, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Chicago Medicine
Chicago, Illinois, United States
IU Health University Hospital
Indianapolis, Indiana, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States
University of Maryland - Shock Trauma Center
Baltimore, Maryland, United States
Johns Hopkins Hospital - Bayview Medical Center
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Maryland - Capital Region
Largo, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Missouri Hospital
Columbia, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Jamaica Hospital Medical Center
The Bronx, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Brown University Health
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
UW Medical Center
Seattle, Washington, United States
University of Wisconsin Health University Hospital
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States