About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with lower extremity osteoarticular infections with or without hardware
Disqualifiers
patients who are hemodynamically unstable or have altered mental status and cannot give consent
patient per investigators discretion are excluded
Trial design
Parallel
Treatments tested in this trial
Antibiotic loaded calcium sulfate beads
DrugCalcium 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)
DeviceCalcium sulfate beads will be prepared without added antibiotics and placed during the second surgery.
Treatment groups
Trial outcomes
Primary outcomes
End of Therapy - Clinical Failure
1. Presence of at least one clinical criterium for failure (frank pus adjacent to bone or implant or draining sinus tract), OR 2. phenotypically indistinguishable bacteria isolated from two or more deep-tissue samples or a single closed aspirate or biopsy OR 3. histologic criteria including presence of characteristic inflammatory infiltrate or microorganisms.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: