Ciprofloxacin-Coated Tympanostomy Tubes with Sustained-Release Varnish: A Novel Strategy to Combat Biofilm Formation by Pseudomonas aeruginosa

Objective: The aim of this study is to develop and evaluate the antibacterial and anti-biofilm efficacy of ciprofloxacin-coated tympanostomy tubes (TTs) using a sustained-release varnish (SRV-CIPRO) and introduce a novel tympanic membrane model for preclinical evaluation. Study Design: This was an in vitro experimental study. Setting: This study was conducted in a biofilm research laboratory in an academic medical center. Methods: Sterile fluoroplastic TTs were coated with SRV-CIPRO or placebo varnish. A novel tympanic membrane (TM) model was developed using a layered agar–plastic system. Antibacterial activity, biofilm inhibition, and bacterial viability were assessed through agar diffusion, MTT, ATP quantification, HR-SEM, and SD-CLSM. Results: SRV-CIPRO-coated TTs exhibited sustained antibacterial activity for up to 10 days. Compared to the placebo, SRV-CIPRO significantly inhibited biofilm formation, reduced metabolic activity, and decreased bacterial viability (p < 0.05). Imaging confirmed fewer bacterial colonies on SRV-CIPRO TTs. The TM model allowed realistic testing of tube insertion and infection simulation. Conclusion: SRV-CIPRO-coated TTs offer sustained antibiotic delivery, potentially reducing postoperative otorrhea and biofilm-related complications. The TM model provides a platform for preclinical evaluation of middle ear devices.