Intramedullary Calcium Sulfate Antibiotic Depot

• Status: Not yet recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Gentamicins; Vancomycin

Criteria

Inclusion Criteria:

• Patients 18 years and older

• 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 tobramycin

• Hypercalcemia

• Unable to speak English or Spanish

• No email, phone, or other point of contact

• Pregnant and lactating women

• Prisoner