Intramedullary Calcium Sulfate Antibiotic Depot
Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
Wake Forest University Health Sciences
497 participants
Apr 8, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- Patients 18 years and older
- Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Exclusion Criteria7
- 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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Interventions
The intramedullary calcium sulfate antibiotic depot will be mixed sterilely to include at minimum 20cc calcium sulfate powder mixed with 1g of vancomycin powder and 1.2g of tobramycin powder per 10cc of calcium sulfate.
The intramedullary calcium sulfate antibiotic depot will be mixed sterilely to include at minimum 20cc calcium sulfate powder mixed with 1g of vancomycin powder and 1.2g of tobramycin powder per 10cc of calcium sulfate.
Standard Intramedullary Nail
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT05766670