NCT05421741 Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
| NCT ID | NCT05421741 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Osteomyelitis Tibia |
| Study Type | INTERVENTIONAL |
| Enrollment | 484 participants |
| Start Date | 2023-05-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 484 participants in total. It began in 2023-05-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
Eligibility 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
Contact & Investigator
Joseph Hsu, MD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05421741 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteomyelitis Tibia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05421741 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05421741 currently recruiting?
Yes, NCT05421741 is actively recruiting participants. Contact the research team at Rachel.Seymour@advocatehealth.org for enrollment information.
Where is the NCT05421741 trial being conducted?
This trial is being conducted at Gainesville, United States, Temple Terrace, United States, Macon, United States, Lexington, United States and 10 additional locations.
Who is sponsoring the NCT05421741 clinical trial?
NCT05421741 is sponsored by Wake Forest University Health Sciences. The principal investigator is Joseph Hsu, MD at Wake Forest University Health Sciences. The trial plans to enroll 484 participants.