Accelerated flap coverage for severe lower leg injuries

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

This study is testing if getting surgery to cover severe leg injuries within 72 hours helps reduce infections better than the usual timing for treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 356 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (other)
• Locations: 9 sites (Sacramento, California and 8 other locations)
• Trial ID: NCT06293469 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of accelerated flap coverage within 72 hours of injury to standard flap coverage timing in patients with severe lower extremity open fractures and dislocations. Participants will be randomly assigned to one of the two treatment groups, and the primary outcome will assess infection-related complications and overall clinical status six months post-randomization. The study seeks to address the critical knowledge gap regarding optimal timing for soft tissue coverage to reduce infection rates, which are currently high in the U.S. compared to the U.K. guidelines. A total of 356 participants will be enrolled in this trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with acute open fractures or dislocations below the knee requiring flap coverage.

Not a fit: Patients who are expected to undergo primary amputation or have critical limb ischemia will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce infection rates and improve recovery outcomes for patients with severe lower extremity injuries.

How similar studies have performed: While there is promising data supporting early flap coverage, this trial is necessary to provide definitive evidence, as similar studies have not yet established a consensus.

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.

Where this trial is running

Sacramento, California and 8 other locations

• UC Davis Medical Center — Sacramento, California, United States (RECRUITING)
• R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States (RECRUITING)
• John Hopkins Bayview Medical Center — Baltimore, Maryland, United States (RECRUITING)
• The Johns Hopkins Hospital — Baltimore, Maryland, United States (RECRUITING)
• University of Maryland Capital Region Medical Center — Largo, Maryland, United States (RECRUITING)
• Oregon Health & Science University — Portland, Oregon, United States (RECRUITING)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
• The Alfred Hospital — Melbourne, Victoria, Australia (RECRUITING)
• Vall d'Hebron University Hospital — Barcelona, Spain (RECRUITING)

Study contacts

• Principal investigator: Lily Mundy, MD — Johns Hopkins School of Medicine
• Study coordinator: Lily Mundy, MD

Conditions: Open Tibia Fracture, Open Dislocation of Ankle, Extremity Fracture Lower, Extremity Injuries Lower