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Intramedullary Calcium Sulfate Antibiotic Depot

RecruitingPhase 3Ages 18 Years - anyAllWake Forest University Health Sciences
NCT05766670 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients 18 years and older * Type II or III open tibia fracture requiring definitive fixation with intramedullary nail Exclusion Criteria: * Less than 18 years of age * Allergy to vancomycin or tobramycin * Hypercalcemia * Unable to speak English or Spanish * No email, phone, or other point of contact * Pregnant and lactating women * Prisoner
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What it tests

  • Vancomycin Hydrochloride
  • Gentamicin
  • Standard Intramedullary Nail
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Where

12 sites
Cedars-Sinai
Los Angeles, United States
Atrium Health Navicent The Medical Center
Macon, United States
University of Chicago
Chicago, United States
University of Kentucky
Lexington, United States
Louisiana State University Health Sciences Center
New Orleans, United States
Atrium Health Carolinas Medical Center
Charlotte, United States
Atrium Health Cabarrus
Concord, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, United States

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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