Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients 18 years and older
• Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Locations
United States
California
Cedars-Sinai
NOT_YET_RECRUITING
Los Angeles
Georgia
Atrium Health Navicent The Medical Center
RECRUITING
Macon
Kentucky
University of Kentucky
NOT_YET_RECRUITING
Lexington
Louisiana
Louisiana State University Health Sciences Center
RECRUITING
New Orleans
North Carolina
Atrium Health Carolinas Medical Center
RECRUITING
Charlotte
Atrium Health Cabarrus
RECRUITING
Concord
Atrium Health Wake Forest Baptist Medical Center
RECRUITING
Winston-salem
Pennsylvania
Pennsylvania State University
NOT_YET_RECRUITING
Hershey
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Virginia
Valley Health
NOT_YET_RECRUITING
Winchester
Contact Information
Primary
Christine Churchill, MA
christine.churchill@atriumhealth.org
7043552000
Backup
Rachel B Seymour, PhD
rachel.seymour@atriumhealth.org
7043552000
Time Frame
Start Date: 2024-04-08
Estimated Completion Date: 2028-01
Participants
Target number of participants: 497
Treatments
Other: 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.
Other: Standard of care intramedullary nail (SN)
Standard of care intramedullary nail
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences