Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
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.
Eligibility criteria
Qualifiers
Patients 18 years or older
Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Disqualifiers
Less than 18 years of age
Allergy to vancomycin or gentamicin
Unable to speak English or Spanish
Pregnant and lactating women
Trial design
Treatments tested in this trial
- Antibiotic coated intramedullary Nail
- Standard Intramedullary Nail
Treatment groups
484 Participants
are divided into 2 treatment groupsLocations
14Florida
University of Florida Gainesville32607, Gainesville United States
Florida Orthopaedic Institute33637, Temple Terrace United States
Georgia
Atrium Health Navicent31201, Macon United States
Kentucky
University of Kentucky40536, Lexington United States
Sponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Source ClinicalTrials.gov