Status:
RECRUITING
Accelerated Flap Coverage in Severe Lower Extremity Trauma
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
McMaster University
University of Maryland, Baltimore
Conditions:
Open Tibia Fracture
Open Dislocation of Ankle
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
Detailed Description
Infection following severe lower extremity musculoskeletal injuries is a challenging problem. Several factors hypothesized to influence infection have been explored and, in many cases, optimized or fo...
Eligibility Criteria
The inclusion criteria are:
- 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.
The exclusion criteria are:
- 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 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).
- Other reason to exclude the patient, as approved by the Principal Investigators.
Key Trial Info
Start Date :
November 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT06293469
Start Date
November 4 2024
End Date
February 1 2030
Last Update
October 14 2025
Active Locations (9)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817
2
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
3
John Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
4
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287