Using an antibiotic depot to prevent infections in open tibia fractures
Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
This study is testing if a new antibiotic treatment can help prevent infections in people with open tibia fractures compared to standard care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 497 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT05766670 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Type II or III open tibia fractures requiring definitive fixation.
Not a fit: Patients under 18, those with allergies to the antibiotics used, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of infections in patients with open tibia fractures.
How similar studies have performed: Other studies have explored antibiotic delivery methods, but this specific approach using a calcium sulfate depot is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California and 9 other locations
- Cedars-Sinai — Los Angeles, California, United States (Recruiting)
- Atrium Health Navicent The Medical Center — Macon, Georgia, United States (Recruiting)
- University of Kentucky — Lexington, Kentucky, United States (Not_yet_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)
- Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
- Pennsylvania State University — Hershey, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Not_yet_recruiting)
- Valley Health — Winchester, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Rachel B Seymour, PhD — Wake Forest University Health Sciences
- Study coordinator: Christine Churchill, MA
- Email: christine.churchill@atriumhealth.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.