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.