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Intramedullary Calcium Sulfate Antibiotic Depot

RecruitingPhase 3

Sponsor: Wake Forest University Health Sciences

Conditions: Open tíbia Fracture, Osteomyelitis Tibia, Tibial Fractures

Interventions: Vancomycin Hydrochloride, Gentamicin, Standard Intramedullary Nail

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (10)

Los Angeles, California, United States
Macon, Georgia, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Charlotte, North Carolina, United States
Concord, North Carolina, United States
Winston-Salem, North Carolina, United States
Hershey, Pennsylvania, United States
Nashville, Tennessee, United States
Winchester, Virginia, United States