RecruitingPhase 4NCT05421741
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Sponsor
Wake Forest University Health Sciences
Enrollment
484 participants
Start Date
May 15, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 18 Years
Inclusion Criteria2
- Patients 18 years or older
- Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Exclusion Criteria6
- 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
Interventions
OTHERStandard Intramedullary Nail
Standard Intramedullary Nail
DRUGAntibiotic coated intramedullary Nail
Antibiotic coated intramedullary nail: A mixture of 40gm bag of acrylic cement, antibiotic powder (Vancomycin 2gm) and 560mg gentamicin liquid. The intramedullary is coated with the mixture using a cement gun tube.
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05421741