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Recruiting NCT05766670

Intramedullary Calcium Sulfate Antibiotic Depot

Conditions: Open tíbia Fracture, Osteomyelitis Tibia, Tibial Fractures

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE3

Enrollment: 497

Sponsor: Wake Forest University Health Sciences

Location: Cedars-Sinai Los Angeles California

Summary

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05766670). StuddyBuddy aggregates publicly available trial information.