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.
Accelerated Flap Coverage in Severe Lower Extremity Trauma
At a glance
Conditions
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.
Study leadership
- Lily Mundy, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins School of Medicine
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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)