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Intramedullary Calcium Sulfate Antibiotic Depot

Antibiotic treatment using a calcium sulfate depot inside the bone.

Recruiting
18 years and older
All
Phase 3

This study is about finding the best way to prevent infections after a serious leg break called an open tibia fracture. A randomized clinical trial means some people will get one treatment, and others will get a different one to see which works better. The new treatment involves using calcium sulfate antibiotic depot (a special medicine placed inside the bone) along with the usual care. The usual care includes cleaning the wound, fixing the bone with a rod inside it (called intramedullary nailing), and giving antibiotics to fight infection.

  • Study Duration: Participants will be followed for 12 months.
  • Visits: Data will be collected at the start, 6 weeks, 3 months, 6 months, and 12 months.
  • Eligibility: Must be 18 or older, with a severe open tibia fracture.

If you join, you'll be in either the group using the new medicine or the one with usual care. It's important to know you can’t be part of the study if you're allergic to certain antibiotics or have conditions like hypercalcemia (too much calcium in the blood). There are no emojis in this web version to ensure clear communication.

Study details
    Open tíbia Fracture
    Osteomyelitis Tibia
    Tibial Fractures

NCT05766670

Wake Forest University Health Sciences

1 April 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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