Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

• Status: Not yet recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Anti-Bacterial Agents; Gentamicins; Tobramycin; Vancomycin

Criteria

Inclusion Criteria:

• Patients 18 years or older

• Gustillo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail

Exclusion Criteria:

• Less than 18 years of age

• Allergy to vancomycin, tobramycin, or gentamicin

• Unable to speak English or Spanish,

• Pregnant and lactating women

• Prisoner

• Unable to follow up for 12 months