NCT05766670 Intramedullary Calcium Sulfate Antibiotic Depot
| NCT ID | NCT05766670 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Open tíbia Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 242 participants |
| Start Date | 2024-04-08 |
| Primary Completion | 2027-01 |
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 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 242 participants in total. It began in 2024-04-08 with a primary completion date of 2027-01.
⚠ 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
The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.
Eligibility 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
Contact & Investigator
Rachel B Seymour, PhD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05766670 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Open tíbia Fracture. 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 NCT05766670 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 242 participants.
Is NCT05766670 currently recruiting?
Yes, NCT05766670 is actively recruiting participants. Contact the research team at christine.churchill@advocatehealth.org for enrollment information.
Where is the NCT05766670 trial being conducted?
This trial is being conducted at Los Angeles, United States, Macon, United States, Chicago, United States, Lexington, United States and 8 additional locations.
Who is sponsoring the NCT05766670 clinical trial?
NCT05766670 is sponsored by Wake Forest University Health Sciences. The principal investigator is Rachel B Seymour, PhD at Wake Forest University Health Sciences. The trial plans to enroll 242 participants.