RecruitingPhase 4NCT05421741

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial


Sponsor

Wake Forest University Health Sciences

Enrollment

484 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an antibiotic-coated intramedullary nail (a metal rod inserted into the bone) can reduce the risk of serious bone infections in people with severe open leg fractures. Open tibia fractures — where the bone breaks through the skin — carry a high risk of infection, and coating the nail with antibiotics may help prevent this. **You may be eligible if...** - You are 18 or older - You have a severe open tibia (shin bone) fracture that requires surgery with an intramedullary nail for fixation - Your fracture is classified as Gustilo Type II or III (moderate to severe open fracture) **You may NOT be eligible if...** - You are under 18 - You are allergic to vancomycin or gentamicin (the antibiotics on the nail) - You do not speak English or Spanish - You are pregnant or breastfeeding - You have a pre-existing bone infection at the fracture site Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAntibiotic 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.

OTHERStandard Intramedullary Nail

Standard Intramedullary Nail


Locations(14)

University of Florida Gainesville

Gainesville, Florida, United States

Florida Orthopaedic Institute

Temple Terrace, Florida, United States

Atrium Health Navicent

Macon, Georgia, United States

University of Kentucky

Lexington, Kentucky, United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States

Atrium Health Cabarrus

Concord, North Carolina, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Houston

Houston, Texas, United States

San Antonio Military Medical Center

San Antonio, Texas, United States

Carilion Clinic

Roanoke, Virginia, United States

Valley Health System

Winchester, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05421741


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