Accelerated Flap Coverage in Severe Lower Extremity Trauma (NCT06293469)
Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: UC Davis Medical Center — Sacramento, California
Age range: 18 Years
🧪 Interventions in This Study
- Accelerated Flap Coverage Surgery (PROCEDURE)
- Standard of Care Flap Timing (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- UC Davis Medical Center — Sacramento, California
- R Adams Cowley Shock Trauma Center — Baltimore, Maryland
- John Hopkins Bayview Medical Center — Baltimore, Maryland
- The Johns Hopkins Hospital — Baltimore, Maryland
- University of Maryland Capital Region Medical Center — Largo, Maryland
- Oregon Health & Science University — Portland, Oregon
- Vanderbilt University Medical Center — Nashville, Tennessee
- The Alfred Hospital — Melbourne, Victoria
- Vall d'Hebron University Hospital — Barcelona,
📞 Contact the Study Coordinator
Phone: (410) 706-2492
Email: LMundy3@jhu.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Open Tibia Fracture clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.