Accelerated Flap Coverage in Severe Lower Extremity Trauma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About 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).

Eligibility criteria

Qualifiers

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.

Will have all planned flap surgeries performed by a participating surgeon or delegate.

Able to be randomized within 48 hours of injury.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Accelerated Flap Coverage Surgery
  • Standard of Care Flap Timing

Treatment groups

356 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

McMaster University

Collaborator

University of Maryland, Baltimore

Collaborator

Orthopaedic Trauma Association

Collaborator

Foundation of Orthopedic Trauma

Collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator