Effects of Ethylene Oxide Sterilisation on the In Vitro Antimicrobial Activity of Preformulated Antibiotic-Impregnated Calcium Sulfate Beads.

Gas-sterilized antibiotic-impregnated calcium sulfate beads retain antimicrobial activity for 6 months post-curation.

This prospective controlled laboratory study evaluated whether ethylene oxide gas sterilization affects antibiotic elution and antimicrobial activity from calcium sulfate beads impregnated with amikacin, gentamicin, cefazolin, or vancomycin. Three-millimeter diameter beads were tested with or without gas sterilization at multiple timepoints: 1 day, 1 week, 1 month, 3 months, and 6 months post-curation. Antimicrobial activity was assessed using Modified Kirby-Bauer agar diffusion assays measuring zones of inhibition (ZOI) over 5 consecutive days of elution. Results demonstrated that ethylene oxide-sterilized beads produced similar ZOI compared to nonsterilized controls during the 5-day elution period. Importantly, sterilized beads stored for up to 6 months maintained comparable antimicrobial activity to nonsterilized beads tested immediately. These findings indicate that antibiotic-impregnated calcium sulfate beads can be preformulated, gas-sterilized, and stored in clinical settings while maintaining their antimicrobial efficacy for at least 6 months, potentially improving clinical efficiency and reducing preparation time.

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