Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 13, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new type of treatment for patients with serious leg injuries, specifically open tibia fractures, which are breaks in the shinbone that can lead to infections. The researchers want to see if using a special nail coated with antibiotics (medicine that fights infections) can help prevent infections better than the standard method of fixing these fractures. The trial is currently recruiting participants aged 18 and older who have certain types of open tibia fractures and need surgery to fix the break.
If you or a loved one qualifies for this study, you will receive either the antibiotic-coated nail or the traditional treatment. Participants will be followed for 12 months after their treatment to see how well they heal and if they develop any infections. It's important to note that people who are younger than 18, allergic to specific antibiotics, or unable to follow up for a year are not eligible for this trial. This study aims to improve the care for patients with serious leg fractures by exploring a new way to prevent infections.
Gender
ALL
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
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lexington, Kentucky, United States
Augusta, Georgia, United States
Nashville, Tennessee, United States
Galveston, Texas, United States
Hershey, Pennsylvania, United States
Houston, Texas, United States
Temple Terrace, Florida, United States
San Antonio, Texas, United States
Roanoke, Virginia, United States
Winchester, Virginia, United States
Winston Salem, North Carolina, United States
Fairfax, Virginia, United States
Concord, North Carolina, United States
Charlotte, North Carolina, United States
Macon, Georgia, United States
Gainesville, Florida, United States
Chapel Hill, North Carolina, United States
New Orleans, Louisiana, United States
Patients applied
Trial Officials
Joseph Hsu, MD
Principal Investigator
Wake Forest University Health Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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