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Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

RecruitingPhase 4

Sponsor: Wake Forest University Health Sciences

Conditions: Osteomyelitis Tibia, Tibial Fractures, Open Tibia Fracture

Interventions: Antibiotic coated intramedullary Nail, Standard Intramedullary Nail

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients 18 years or older
* Gustilo 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 gentamicin
* Unable to speak English or Spanish
* Pregnant and lactating women
* Prisoner
* Unable to follow up for 12 months

Locations (15)

Gainesville, Florida, United States
Temple Terrace, Florida, United States
Macon, Georgia, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Chapel Hill, North Carolina, 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
Houston, Texas, United States
San Antonio, Texas, United States
Roanoke, Virginia, United States
Winchester, Virginia, United States