Intramedullary Calcium Sulfate Antibiotic Depot
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
Qualifiers
Patients 18 years and older
Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Disqualifiers
Less than 18 years of age
Allergy to vancomycin or tobramycin
Hypercalcemia
Unable to speak English or Spanish
Trial design
Treatments tested in this trial
- Vancomycin Hydrochloride
- Gentamicin
- Standard Intramedullary Nail
Treatment groups
497 Participants
are divided into 2 treatment groupsLocations
10California
Cedars-Sinai90048, Los Angeles United States
Georgia
Atrium Health Navicent The Medical Center31201, Macon United States
Kentucky
University of Kentucky40508, Lexington United States
Louisiana
Louisiana State University Health Sciences Center70112, New Orleans United States
Sponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Source ClinicalTrials.gov