Accelerated Flap Coverage for Leg Injuries
(FLAP ATTACK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Who Is on the Research Team?
Lily HMIR Mundy, MD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for people with severe leg injuries below the knee, such as open fractures or dislocations, who need flap surgery to cover wounds. Participants must be able to have surgery within a set timeframe and not have conditions that would prevent safe participation.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Accelerated Flap Coverage Surgery
- Standard of Care Flap Timing
Trial Overview
The study compares two approaches: having flap coverage surgery within 72 hours of injury (accelerated) versus waiting for the usual timing at each hospital (standard care). Patients are randomly assigned to one group or the other.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Accelerated 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.
The 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
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