Intramedullary Calcium Sulfate Antibiotic Depot
Recruiting
Phase 3
Interventional Study
Open tíbia Fracture
Osteomyelitis Tibia
Tibial Fractures
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 497 (estimated)
- Sponsor
- Wake Forest University Health Sciences · Other
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About This Trial
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.
Trial Locations
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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, phon…
Contacts