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Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Trial testing antibiotic-coated nails to reduce infection risk.

Recruiting
18 years and older
All
Phase 4

This study looks at using a special **antibiotic-coated nail** to help prevent infections in people with serious leg bone (tibia) fractures. The study compares this new nail to the regular treatment method, which uses a nail without the special coating. An antibiotic is a medicine that fights infections caused by bacteria. The **intramedullary (IM) nail** is a rod placed inside the bone to help it heal. The study will run for **12 months**, with check-ins at the start, 6 weeks, 3 months, 6 months, and 12 months. It aims to see if the special nail can lower the number of deep infections, as these can lead to more hospital visits and sometimes even the need for amputation. This study is for people 18 years or older with certain types of open tibia fractures.

  • Study lasts for **12 months** with several follow-up visits.
  • Participants must be 18 or older with specific leg fractures.
  • Some people, like those allergic to certain antibiotics, cannot join.
Study details
    Osteomyelitis Tibia
    Tibial Fractures
    Open Tibia Fracture

NCT05421741

Wake Forest University Health Sciences

3 May 2025

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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