NCT05421741 · Wake Forest University Health Sciences
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
What this study is about
This forward-looking randomly assigned clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional the usual treatment intramedullary (IM) nailing.
View original scientific description
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.
Interventions
DRUG
Antibiotic coated intramedullary Nail
Antibiotic coated intramedullary nail: A mixture of 40gm bag of acrylic cement, antibiotic powder (Vancomycin 2gm) and 560mg gentamicin liquid. The intramedullary is coated with the mixture using a cement gun tube.
OTHER
Standard Intramedullary Nail
Standard Intramedullary Nail
Primary outcome measures
Number of Participants who develop deep surgical site infection (SSI)
Time frame: Day 30 through month 12
Number of participants in each group who develop SSI as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Unable to follow up for 12 months
Where
- Gainesville, Florida
- Temple Terrace, Florida
- Macon, Georgia
- Lexington, Kentucky
- Chapel Hill, North Carolina
- Charlotte, North Carolina
- Concord, North Carolina
- Winston-Salem, North Carolina
- Hershey, Pennsylvania
- Nashville, Tennessee
- Houston, Texas
- San Antonio, Texas
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 26, 2026 · Source of record for eligibility and locations