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Antibiotic Impregnated Beads in Osteomyelitis
Sponsor: University of Arizona
Summary
Lower extremity bone infections, such as osteomyelitis, often occur after bone fractures, surgery, or when prosthetic joints or hardware become infected. Treatment usually includes antibiotics, chosen based on the infection's specifics. Options include intravenous (IV) or oral antibiotics, and sometimes local treatment with antibiotic-loaded beads placed directly at the infection site. Traditionally, these beads are made of non-absorbable materials, requiring a second surgery to remove them. However, a newer approach uses absorbable calcium sulfate beads, which can deliver higher antibiotic doses and don't need removal. This study will compare the use of IV and/or antibiotics in combination with absorbable antibiotic calcium sulfate beads with IV and/or oral antibiotics without absorbable beads, which serves as the current standard of care.
Official title: Utility of Antibiotic Impregnated Beads in Lower Extremity Osteomyelitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-09-01
Completion Date
2027-09-30
Last Updated
2025-07-18
Healthy Volunteers
No
Interventions
Antibiotic loaded calcium sulfate beads
Calcium sulfate beads will be loaded with best available antibiotics based on surgeon/infectious disease specialist determination from the following options (vancomycin, daptomycin, cefazolin, cefepime, tobramycin, amphotericin B, micafungin, and voriconazole).
Calcium sulfate beads (sham beads)
Calcium sulfate beads will be prepared without added antibiotics and placed during the second surgery.