Preventing Infection in Open Tibia Fractures
This study is looking for the best way to prevent infections after severe open lower leg (tibia) fractures. Researchers are comparing a standard treatment to a new approach using an antibiotic depot. This depot is a mixture of calcium sulfate powder with vancomycin hydrochloride and tobramycin powder, placed inside the bone during surgery. The study aims to see if this antibiotic depot is better at preventing deep surgical site infections compared to the standard treatment. You might be able to join if you are 18 or older with a specific type of open tibia fracture requiring surgery, and you don't have allergies to the study medications or certain other health conditions. The study plans to enroll 497 participants.
- Study design
- This is a randomized clinical trial comparing two groups of participants, with a planned enrollment of 497 people.
- What's involved
- You would be followed for 12 months, with data collected at baseline, 6 weeks, 3 months, 6 months, and 12 months through interviews and medical records.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Intramedullary Calcium Sulfate Antibiotic Depot
At a glance
Conditions
Where it's being run
10 sites across 8 statesStudy leadership
- Rachel B Seymour, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences
- Jessica Rivera, MD · PRINCIPAL_INVESTIGATOR · Louisiana State University Health Science Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of participants who develop deep surgical site infection (SSI)Month 12
Number of participants in each group who develop surgical site infection (SSI) as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.