Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
497 participants
INTERVENTIONAL
2024-04-08
2028-01-31
Brief Summary
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Detailed Description
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This prospective randomized clinical trial will compare outcomes between patients treated with an antibiotic depot placed inside the bone at the time of final fracture fixation and those treated with traditional standard of care intramedullary nailing.
The target population for the proposed study is patients with severe open tibia fractures (Type II or III) who require definitive fixation with intramedullary nail recruited form one of the participating sites during the index hospitalization.
One group will be treated prophylactically suing a calcium sulfate antibiotic depot at the time of definitive fixation, while the second group will be treated with a standard of care intramedullary nail without the antibiotic depot.
Participants will be followed for 12 months (data capture includes patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS)
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.
Vancomycin 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.
Gentamicin
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.
Standard of care intramedullary nail (SN)
Standard of care intramedullary nail
Standard Intramedullary Nail
Standard Intramedullary Nail
Interventions
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Vancomycin 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.
Gentamicin
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.
Standard Intramedullary Nail
Standard Intramedullary Nail
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Rachel B Seymour, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Jessica Rivera, MD
Role: PRINCIPAL_INVESTIGATOR
Louisiana State University Health Science Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Geoffrey Marecek, MD
Role: primary
Paul Matuszewski, MD
Role: primary
Jana Davis, MD
Role: primary
William Obremskey
Role: primary
Ken Nelson, MD
Role: primary
Other Identifiers
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W81XWH-22-10937
Identifier Type: OTHER
Identifier Source: secondary_id
W81XWH-22-10937
Identifier Type: -
Identifier Source: org_study_id
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