Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
Wake Forest University Health Sciences
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.
Description
This research is a randomized clinical trial aimed to reduce the frequency of fracture related infections following open tibia fracture. The proposed test methods for infection reduction is use of an antibiotic depot placed inside the bone at the time of final fracture treatment. This is in addition to standard of care wound care, fracture fixation with intramedullary nailing, and peri-operative systemic antibiotics. This prospective randomized clinical trial will compare outcomes between patients treated with an antibiotic depot placed inside the bone at the time of final fracture fixation a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugVancomycin Hydrochloride
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.
- DrugGentamicin
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.
- OtherStandard Intramedullary Nail
Standard Intramedullary Nail
Locations (10)
- Cedars-SinaiLos Angeles, California
- Atrium Health Navicent The Medical CenterMacon, Georgia
- University of KentuckyLexington, Kentucky
- Louisiana State University Health Sciences CenterNew Orleans, Louisiana
- Atrium Health Carolinas Medical CenterCharlotte, North Carolina
- Atrium Health CabarrusConcord, North Carolina