Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
Abstract
The successful treatment of bone infection is improved by both local and systemically administered antibiotics. One method for local application of antibiotic to bone is via the simple use of clinically available calcium sulfate (CS) bone void fillers mixed with antibiotic and instilled into the medullary canal. This randomized clinical trial will enroll 494 patients at partnering level 1trauma centers who have sustained a Type II or III open tibia fractures and who will be definitively treated with intramedullary nail (IMN) for fracture fixation. The patients will be randomized to either prophylactic intramedullary calcium sulfate antibiotic depot prior to IMN placement (CS) or to standard of care IMN (SN) without intramedullary antibiotics.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2023
- Accession Number
- AD1223122
Entities
People
- Jessica C. Rivera
Organizations
- LSU Health Sciences Center New Orleans