Using an antibiotic depot to prevent infections in open tibia fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized clinical trial aims to determine the effectiveness of a calcium sulfate antibiotic depot in preventing infections in patients with open tibia fractures. Participants will be divided into two groups: one receiving the antibiotic depot during fracture fixation and the other receiving standard care without the depot. The study will follow patients for 12 months, collecting data through interviews and medical records at various intervals. The goal is to assess whether the antibiotic depot can significantly reduce infection rates compared to traditional treatment methods.

Why it matters

Who can join: the full rules

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

Where it's running

• Cedars-Sinai
  Los Angeles, California, United States Recruiting
• Atrium Health Navicent The Medical Center
  Macon, Georgia, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting
• Louisiana State University Health Sciences Center
  New Orleans, Louisiana, United States Recruiting
• Atrium Health Carolinas Medical Center
  Charlotte, North Carolina, United States Recruiting
• Atrium Health Cabarrus
  Concord, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Rachel B Seymour, PhD — Wake Forest University Health Sciences
• Study coordinator: Christine Churchill, MA
• Email: christine.churchill@advocatehealth.org
• Phone: 7043552000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.