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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Antibiotic loaded calcium sulfate beads

    Drug

    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)

    Device

    Calcium sulfate beads will be prepared without added antibiotics and placed during the second surgery.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: IV and/or oral antibiotics with local antibiotic loaded calcium sulfate beadsExperimental treatment 1 intervention
Group B: IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
End of Therapy (usually 4-6 weeks)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: