Actively Recruiting
Accelerated Flap Coverage in Severe Lower Extremity Trauma
Led by Johns Hopkins University · Updated on 2025-10-14
356
Participants Needed
9
Research Sites
273 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
M
McMaster University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Accelerated Flap Coverage in Severe Lower Extremity Trauma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older.
- Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury.
- All planned flap surgeries will be performed by a participating surgeon or delegate.
- Able to be randomized within 48 hours of injury.
You will not qualify if you...
- Site is unable to implement the accelerated flap protocol due to local logistics.
- Primary amputation anticipated prior to attempted flap for management of the injury.
- Critical limb ischemia requiring re-vascularization for limb perfusion.
- Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery.
- Burns at the musculoskeletal injury site.
- Incarceration.
- Expected injury survival of less than 12 months.
- Terminal illness with expected survival of less than 12 months.
- Currently enrolled in a trial that does not permit co-enrollment.
- Declined to provide informed consent.
- Unable to obtain informed consent due to language barriers.
- Unable to obtain informed consent because a legally authorized representative was unavailable.
- Anticipated problems with maintaining follow-up.
- Prior enrollment in the trial.
- Eligible patient or legally authorized representative was not approached within screening window.
- Other reason to exclude the patient, as approved by the Principal Investigators.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
2
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
John Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
4
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
University of Maryland Capital Region Medical Center
Largo, Maryland, United States, 20774
Actively Recruiting
6
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
7
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
8
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
9
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Actively Recruiting
Research Team
L
Lily Mundy, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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