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Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
RecruitingPhase 4
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- Antibiotic coated intramedullary Nail (drug)
- Standard Intramedullary Nail (other)
Sponsor: Wake Forest University Health Sciences · Participants: 242 · Started: May 15, 2023
Contact the study team
- Rachel Seymour, PhD · Phone: 7043552000
- Christine Churchill, MA · Phone: 7043552000
Official record on ClinicalTrials.gov — NCT05421741
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.