Accelerated Flap Coverage for Severe Lower Extremity Trauma

This study is looking at whether getting a flap surgery (a procedure where healthy skin and tissue are moved to cover an injury) sooner can help patients with severe lower leg open fractures or dislocations. You would either receive Accelerated Flap Coverage Surgery, aiming for the surgery within 72 hours of injury, or Standard of Care Flap Timing, which follows the usual timing at the hospital. The main goal is to see if earlier surgery leads to fewer infection-related problems. Doctors will check your clinical status (overall health related to the injury) 6 months after you join the study. To join, you must be 18 or older with a severe open fracture or dislocation below the knee that needs a flap, and be able to join the study within 48 hours of your injury. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants receive a specific treatment. It plans to enroll 356 participants to compare two different timings for flap surgery.
What's involved
You would be randomized to receive either Accelerated Flap Coverage Surgery or Standard of Care Flap Timing. Your clinical status will be evaluated 6 months after joining the study.
Compensation
Not stated in the trial record.
Follow-up
Your clinical status will be measured 6 months after randomization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06293469

Accelerated Flap Coverage in Severe Lower Extremity Trauma

Recruiting
NAAges 18+InterventionalTreatment
Johns Hopkins University
~356 participants
Updated 2026-09-18 on ClinicalTrials.gov
What's tested:Accelerated Flap Coverage SurgeryStandard of Care Flap Timing

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical status
Measured over 6 months
Open Tibia Fracture
Open Dislocation of Ankle
Extremity Fracture Lower
Extremity Injuries Lower

NCT06293469

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Saint John Regional Hospital

    Saint John, New Brunswick, Canadastudy coordinator listed

    Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia, Canadastudy coordinator listed

    Recruiting

  • John Hopkins Bayview Medical Center

    Baltimore, Marylandno site contact published

    Recruiting

  • Oregon Health & Science University

    Portland, Oregonno site contact published

    Recruiting

  • R Adams Cowley Shock Trauma Center

    Baltimore, Marylandno site contact published

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, Australiano site contact published

    Recruiting

  • The Johns Hopkins Hospital

    Baltimore, Marylandno site contact published

    Recruiting

  • UC Davis Medical Center

    Sacramento, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Lily Mundy, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins School of Medicine

Opens a ready-to-send draft in your own email app — review before sending.

  • Clinical status6 months

    Clinical status is a hierarchical composite of the following outcomes: 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) 4. Days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility)