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:

  1. Patients 18 years of age or older.
  2. Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury.
  3. Will have all planned flap surgeries performed by a participating surgeon or delegate.
  4. Able to be randomized within 48 hours of injury.

The exclusion criteria are:

  1. Site is unable to implement the accelerated flap protocol due to local logistics.
  2. Primary amputation anticipated prior to attempted flap for management of the injury.
  3. Critical limb ischemia that requires re-vascularization for limb perfusion.
  4. Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery.
  5. Burns at the musculoskeletal injury site.
  6. Incarceration.
  7. Expected injury survival of less than 12 months.
  8. Terminal illness with expected survival of less than 12 months.
  9. Currently enrolled in a trial that does not permit co-enrollment.
  10. Declined to provide informed consent.
  11. Unable to obtain informed consent due to language barriers.
  12. Unable to obtain informed consent because a legally authorized representative was unavailable.
  13. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
  14. Prior enrollment in the trial.
  15. Eligible patient or LAR was not approached within screening window (missed participant).
  16. 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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Page 1 of 3 (9 locations)

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

Accelerated Flap Coverage in Severe Lower Extremity Trauma | DecenTrialz