Intramedullary Calcium Sulfate Antibiotic Depot
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Mar 8, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new way to help patients with open lower leg fractures, specifically focusing on preventing infections that can occur after such injuries. The researchers want to see if using a special treatment called a calcium sulfate antibiotic depot is more effective than the usual care. This treatment involves placing a substance that releases antibiotics directly at the site of the fracture to help fight off infections.
To participate in the trial, you need to be at least 18 years old and have a specific type of open tibia fracture that requires surgical fixation with a device called an intramedullary nail. Unfortunately, if you have certain allergies, are pregnant, or do not speak English or Spanish, you won't be eligible. If you join, you will be closely monitored throughout the study to see how well this new treatment works compared to standard care. The trial is currently recruiting participants, and both men and women are welcome to apply.
Gender
ALL
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
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
Winston Salem, North Carolina, United States
Nashville, Tennessee, United States
New Orleans, Louisiana, United States
Hershey, Pennsylvania, United States
Los Angeles, California, United States
Lexington, Kentucky, United States
Winchester, Virginia, United States
Concord, North Carolina, United States
Winston Salem, North Carolina, United States
Charlotte, North Carolina, United States
Macon, Georgia, United States
Patients applied
Trial Officials
Rachel B Seymour, PhD
Principal Investigator
Wake Forest University Health Sciences
Jessica Rivera, MD
Principal Investigator
Louisiana State University Health Science Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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