Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07072923
PHASE4

Antibiotic Impregnated Beads in Osteomyelitis

Sponsor: University of Arizona

View on ClinicalTrials.gov

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

DRUG

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).

DEVICE

Calcium sulfate beads (sham beads)

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