Using antibiotic-coated nails to prevent infections in severe 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 clinical trial aims to evaluate the effectiveness of a prophylactic antibiotic-coated nail compared to traditional intramedullary nailing in preventing infections in patients with severe open tibia fractures. The study will recruit adult patients with Gustilo Type II or III fractures requiring definitive fixation and will follow them for 12 months post-treatment. By addressing the high rates of deep infections associated with these injuries, the trial seeks to improve patient outcomes and reduce the risk of complications such as rehospitalization and amputation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients 18 years or older
* Gustilo 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 gentamicin
* Unable to speak English or Spanish
* Pregnant and lactating women
* Prisoner
* Unable to follow up for 12 months

Where it's running

• University of Florida Gainesville
  Gainesville, Florida, United States Recruiting
• Florida Orthopaedic Institute
  Temple Terrace, Florida, United States Recruiting
• Atrium Health Navicent
  Macon, Georgia, United States Recruiting
• The University of Chicago
  Chicago, Illinois, United States Recruiting
• University of Kentucky
  Lexington, Kentucky, United States Recruiting
• University of North Carolina Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Joseph Hsu, MD — Wake Forest University Health Sciences
• Study coordinator: Rachel Seymour, PhD
• Email: Rachel.Seymour@advocatehealth.org
• Phone: 7043552000

Similar studies

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

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• Comparing two types of intramedullary nails for healing tibial fractures

  This study is testing whether a new type of tibial nail helps people with stable tibial fractures heal better and recover faster than the standard nail.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT06679049

• Blood flow restriction–enhanced rehabilitation for people with tibial shaft fractures.

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• Assessing knee osteoarthritis in patients with tibial plateau fractures in Norrbotten

  This study looks at how common knee osteoarthritis is in people from Norrbotten, Sweden who had tibial plateau fractures, and it also checks how different factors might affect their recovery.

  Recruiting Umeå University · Luleå, Norrbotten County · NCT06451510

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.