Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Recruiting
Phase 4
Interventional Study
Osteomyelitis Tibia
Tibial Fractures
Open Tibia Fracture
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 484 (estimated)
- Sponsor
- Wake Forest University Health Sciences · Other
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About This Trial
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.
Trial Locations
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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 …
Contacts