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Antibiotic Impregnated Beads in Osteomyelitis

Sponsored by University of Arizona

About this trial

Last updated 9 months ago

Study ID

STUDY00005515

Status

Not yet recruiting

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Started 8 months ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* patients with lower extremity osteoarticular infections with or without hardware

Exclusion Criteria

* patients who are hemodynamically unstable or have altered mental status and cannot give consent

* patient per investigators discretion are excluded