Characterization of extremity wounds in Operation Iraqi Freedom and Operation Enduring Freedom.
Brett D Owens, John F Kragh, Joseph Macaitis...
https://pubmed.ncbi.nlm.nih.gov/17414553Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID05421741
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Led by Wake Forest University Health Sciences · Updated on 2026-05-26
484
Participants Needed
14
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the prevention of deep infections in patients with severe open tibia fractures. It compares outcomes between those treated with a new antibiotic coated intramedullary nail and those receiving the traditional standard of care intramedullary nail. The study focuses on reducing infections that can lead to disability, rehospitalization, and in severe cases, amputation, especially among active duty military personnel. Participants are randomly assigned to one of two groups: one receives an intramedullary nail coated with a mixture of vancomycin and gentamicin antibiotics, while the other receives a standard uncoated intramedullary nail. The antibiotic coating is applied using a cement mixture during the definitive fixation surgery. The trial follows patients for one year after treatment. During the 12-month follow-up, participants undergo evaluations at baseline, 6 weeks, 3 months, 6 months, and 12 months. These include patient interviews, clinical assessments, and review of medical records. Researchers measure infection rates, bone healing progress using radiographic scores, physical activity levels, return to work or duty, and various aspects of physical and mental health using standardized questionnaires. Safety and treatment outcomes are closely monitored throughout the study period.
CONDITIONS
Brief Title
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Index hospitalization
Participants undergo surgery to receive either a prophylactic antibiotic coated intramedullary nail or a standard intramedullary nail for fixation of severe open tibia fractures.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 12 months
Participants are followed with clinical evaluations and patient interviews to monitor healing, infection status, and functional outcomes.
Visits at 6 weeks, 3 months, 6 months, and 12 months (in-person)
Trial Site Locations
Total: 14 locations
1
University of Florida Gainesville
Gainesville, Florida, United States, 32607
Actively Recruiting
2
Florida Orthopaedic Institute
Temple Terrace, Florida, United States, 33637
Actively Recruiting
3
Atrium Health Navicent
Macon, Georgia, United States, 31201
Actively Recruiting
4
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
5
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27546
Actively Recruiting
6
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
7
Atrium Health Cabarrus
Concord, North Carolina, United States, 28025
Actively Recruiting
8
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
9
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
10
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
11
University of Texas Houston
Houston, Texas, United States, 77030
Actively Recruiting
12
San Antonio Military Medical Center
San Antonio, Texas, United States, 78234
Actively Recruiting
13
Carilion Clinic
Roanoke, Virginia, United States, 24016
Not Yet Recruiting
14
Valley Health System
Winchester, Virginia, United States, 22601
Actively Recruiting
Loading map...
Research Team
R
Rachel Seymour, PhD
C
Christine Churchill, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Microbiology and injury characteristics in severe open tibia fractures from combat.
Travis C Burns, Daniel J Stinner, Andrew W Mack...
https://pubmed.ncbi.nlm.nih.gov/22491628An analysis of outcomes of reconstruction or amputation after leg-threatening injuries.
Michael J Bosse, Ellen J MacKenzie, James F Kellam...
https://pubmed.ncbi.nlm.nih.gov/12477942Infection reduces return-to-duty rates for soldiers with Type III open tibia fractures.
Matthew A Napierala, Jessica C Rivera, Travis C Burns...
https://pubmed.ncbi.nlm.nih.gov/25159355Infectious complications of open type III tibial fractures among combat casualties.
Erica N Johnson, Travis C Burns, Roman A Hayda...
https://pubmed.ncbi.nlm.nih.gov/17638186Extremity War Injuries: Development of Clinical Treatment Principles.
James R Ficke, Andrew N Pollak
https://pubmed.ncbi.nlm.nih.gov/17916782Section 1: Preventing and Managing Infection and Other Complications After Orthopaedic Trauma.
https://pubmed.ncbi.nlm.nih.gov/28323794Rehospitalization after combat injury.
Brendan D Masini, Brett D Owens, Joseph R Hsu...
https://pubmed.ncbi.nlm.nih.gov/21795886Infectious complications and soft tissue injury contribute to late amputation after severe lower extremity trauma.
Jeannie Huh, Daniel J Stinner, Travis C Burns...
https://pubmed.ncbi.nlm.nih.gov/21795878Return to duty after type III open tibia fracture.
Jessica D Cross, Daniel J Stinner, Travis C Burns...
https://pubmed.ncbi.nlm.nih.gov/21885998