Antibiotic Impregnated Beads in Osteomyelitis

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona

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

Qualifiers

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

Treatments tested in this trial

  • Antibiotic loaded calcium sulfate beads
  • Calcium sulfate beads (sham beads)

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators