Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
FLAP ATTACK
2 other identifiers
interventional
356
1 country
31
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2027
Longer than P75 for not_applicable
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2026
CompletedFirst Posted
Study publicly available on registry
September 18, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2030
Study Completion
Last participant's last visit for all outcomes
December 1, 2030
September 18, 2026
September 1, 2026
3.5 years
September 15, 2026
September 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Status
Clinical status is a hierarchical composite of the following outcomes: 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)
6 months
Secondary Outcomes (7)
Mortality
6 and 12 months
Amputation
6 and 12 months
Unplanned re-operation
6 and 12 months
Number of days in hospital
6 and 12 months
Patient-reported health status as assessed by the Euro-QoL (EQ-5D-5L)
6 and 12 months
- +2 more secondary outcomes
Study Arms (2)
Accelerated Flap Coverage
EXPERIMENTALAccelerated flap surgery timing at a goal of within 72 hours from injury. Management of the fracture or dislocation, selection of flap, and post-injury flap management will be at the discretion of the operating surgeons and documented for both treatment groups.
Standard of Care Flap Timing
ACTIVE COMPARATORThe flap surgery will be performed at the standard of care timing for the institution. Management of the fracture or dislocation, selection of flap, and post-injury flap management will be at the discretion of the operating surgeons and documented for both treatment groups.
Interventions
Activation of the accelerated flap pathway with a goal flap time of \<72h from injury
Flap timing at the standard of care timing for the clinical site
Eligibility Criteria
You may qualify if:
- 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.
- Treating surgeon is willing to comply with treatment allocation.
- Able to be randomized within 72 hours of injury.
You may not qualify if:
- Site is unable to implement the accelerated flap protocol due to local logistics.
- 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.
- Expected injury survival of less than 12 months.
- Terminal illness with expected survival of less than 12 months.
- 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 (LAR) was unavailable.
- Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
- Prior enrollment in the trial.
- Eligible patient or LAR was not approached within screening window (missed participant).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
Los Angeles Medical Center
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90084, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
UC San Diego Health
San Diego, California, 92121, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
University of Chicago Medicine
Chicago, Illinois, 60637, United States
IU Health University Hospital
Indianapolis, Indiana, 46202, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Maryland - Shock Trauma Center
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital - Bayview Medical Center
Baltimore, Maryland, 21224, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
University of Maryland - Capital Region
Largo, Maryland, 20774, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of Missouri Hospital
Columbia, Missouri, 65212, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Jamaica Hospital Medical Center
The Bronx, New York, 11418, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43221, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Brown University Health
Providence, Rhode Island, 02903, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
UW Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin Health University Hospital
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lily HMIR Mundy, MD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2026
First Posted
September 18, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
July 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
September 18, 2026
Record last verified: 2026-09