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Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries

Study acronym: FLAP ATTACK
StatusNot Yet Recruiting
PhaseNot applicable
Started2027-01-01
View on ClinicalTrials.gov ↗
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 Details
NCT Number NCT07828613
Lead Sponsor Johns Hopkins University
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions Open Tibia Fracture, Open Dislocation of Ankle, Extremity Fracture Lower, Extremity Injuries Lower
Enrollment 356 participants
Start Date 2027-01-01
Primary Completion 2030-07 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-18