Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Wake Forest University Health Sciences
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.
Description
Despite significant treatment advances and protocols to prevent infection, severe open fractures of the lower extremity still have very high rates of deep infection. Infection in an active duty military population increases disability and decreases the likelihood of returning to duty. In addition, infection is one of the main factors associated with rehospitalization. Further, deep infections have not only resulted in increased disability after injury, infection is implicated as one of the main factors in late amputation. Among service members, only 20-25% with a severe open tibia fracture are…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- 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.
- OtherStandard Intramedullary Nail
Standard Intramedullary Nail
Locations (14)
- University of Florida GainesvilleGainesville, Florida
- Florida Orthopaedic InstituteTemple Terrace, Florida
- Atrium Health NavicentMacon, Georgia
- University of KentuckyLexington, Kentucky
- University of North Carolina Chapel HillChapel Hill, North Carolina
- Atrium Health Carolinas Medical CenterCharlotte, North Carolina