Accelerated flap coverage for severe lower leg injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Lily Mundy, MD — Johns Hopkins School of Medicine
• Study coordinator: Lily Mundy, MD
• Email: LMundy3@jhu.edu
• Phone: 410-706-2492

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.