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Intramedullary Calcium Sulfate Antibiotic Depot
Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Vancomycin Hydrochloride (drug)
- Gentamicin (drug)
- Standard Intramedullary Nail (other)
Sponsor: Wake Forest University Health Sciences · Participants: 497 · Started: Apr 8, 2024
Contact the study team
- Christine Churchill, MA · Phone: 7043552000
- Rachel B Seymour, PhD · Phone: 7043552000
Official record on ClinicalTrials.gov — NCT05766670
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.