Using antibiotic-coated nails to prevent infections in severe tibia fractures
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
This study is testing whether using antibiotic-coated nails can help prevent infections in adults with severe tibia fractures compared to regular nails.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 484 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 14 sites (Gainesville, Florida and 13 other locations) |
| Trial ID | NCT05421741 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Gustilo Type II or III open tibia fractures requiring intramedullary nail fixation.
Not a fit: Patients who are under 18, have allergies to vancomycin or gentamicin, or cannot follow up for 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce infection rates and improve recovery outcomes for patients with severe tibia fractures.
How similar studies have performed: While the use of antibiotic-coated implants is gaining interest, this specific approach in the context of severe tibia fractures is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gainesville, Florida and 13 other locations
- 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)
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Atrium Health Carolinas Medical Center — Charlotte, North Carolina, United States (Recruiting)
- Atrium Health Cabarrus — Concord, North Carolina, United States (Recruiting)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- University of Texas Houston — Houston, Texas, United States (Recruiting)
- San Antonio Military Medical Center — San Antonio, Texas, United States (Recruiting)
- Carilion Clinic — Roanoke, Virginia, United States (Not_yet_recruiting)
- Valley Health System — Winchester, Virginia, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.