Antibiotic Coated Nail for Open Tibia Fractures

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Recruiting Phase 4 Interventional Study
Osteomyelitis Tibia Tibial Fractures Open Tibia Fracture
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
242 (estimated)
Sponsor
Wake Forest University Health Sciences · Other
Who this trial is looking for

This trial is looking for adults with specific types of open tibia fractures. Participants will receive either a new antibiotic-coated nail or a traditional nail to fix their fracture and help prevent infections.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 18 years or older
  • I have a Gustilo Type II or III open tibia fracture
  • I need an intramedullary nail for my fracture

You may not be able to join if

  • I am under 18 years old
  • I am allergic to vancomycin or gentamicin
  • I cannot speak English or Spanish
  • I am pregnant or breastfeeding
  • I am a prisoner
  • I cannot follow up for 12 months

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial

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.

Trial Locations
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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 …
Contacts

Rachel Seymour, PhD

7043552000

Rachel.Seymour@advocatehealth.org

CONTACT

Christine Churchill, MA

7043552000

Christine.Churchill@advocatehealth.org

CONTACT