Intramedullary Calcium Sulfate Antibiotic Depot

Phase 3

Recruiting

• Conditions: Open tíbia Fracture; Osteomyelitis Tibia; Tibial Fractures

• Registration Number: NCT05766670
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-2-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 497

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients 18 years and older<br><br> - Type II or III open tibia fracture requiring definitive fixation with intramedullary<br> nail<br><br>Exclusion Criteria:<br><br> - Less than 18 years of age<br><br> - Allergy to vancomycin or tobramycin<br><br> - Hypercalcemia<br><br> - Unable to speak English or Spanish<br><br> - No email, phone, or other point of contact<br><br> - Pregnant and lactating women<br><br> - Prisoner

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants who develop deep surgical site infection (SSI)