Phosphorylcholine-coated antibiotic tympanostomy tubes: Are post-tube placement complications reduced?

Objective: To determine if a phosphorylcholine (PC) antibacterial coating on standard Armstrong beveled tympanostomy tubes (TT) reduced the incidence of post-tube placement complications. Methods: A prospective cohort aged 8-51 months received bilateral TTs for otitis media with effusion between July 2002 and February 2004 at a tertiary care pediatric hospital. Seventy children were randomized to receive a PC-coated TT in one ear and an uncoated TT in the other. Otologic examinations at prescribed intervals over two years post-operatively ascertained the status of sequelae. We analyzed the incidence of TT complications: otorrhea, premature extrusion, persistent tympanic membrane perforations, granulation tissue, and ventilation tube lumen obstruction. Results: There was no statistical difference in the incidence of any of these sequelae between standard and PC-coated tympanostomy tubes (p > 0.05) during the 24-month-follow-up period. Results after 13 months of follow-up may have been affected by patients lost to follow-up and therefore a smaller sample size as the study continued. Conclusions: This study found that there is no statistically significant difference in the incidence of complications between uncoated and PC-coated fluoroplastic Armstrong beveled TTs. (C) 2008 Published by Elsevier Ireland Ltd.