RecruitingPhase 3NCT05766670

Intramedullary Calcium Sulfate Antibiotic Depot

Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial


Sponsor

Wake Forest University Health Sciences

Enrollment

497 participants

Start Date

Apr 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Gentamicin, Standard Intramedullary Nail, and others for people with open tíbia fracture, osteomyelitis tibia, and other related conditions. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years and older.

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

DRUGVancomycin Hydrochloride

The intramedullary calcium sulfate antibiotic depot will be mixed sterilely to include at minimum 20cc calcium sulfate powder mixed with 1g of vancomycin powder and 1.2g of tobramycin powder per 10cc of calcium sulfate.

DRUGGentamicin

The intramedullary calcium sulfate antibiotic depot will be mixed sterilely to include at minimum 20cc calcium sulfate powder mixed with 1g of vancomycin powder and 1.2g of tobramycin powder per 10cc of calcium sulfate.

OTHERStandard Intramedullary Nail

Standard Intramedullary Nail


Locations(10)

Cedars-Sinai

Los Angeles, California, United States

Atrium Health Navicent The Medical Center

Macon, Georgia, United States

University of Kentucky

Lexington, Kentucky, United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 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 Medical Center

Winston-Salem, North Carolina, United States

Pennsylvania State University

Hershey, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Valley Health

Winchester, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05766670


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