Role of albumin coating of tympanostomy tubes: long-term clinical evaluation

OBJECTIVE: Our previous work has shown that albumin coating of tympanostomy tubes prevented adhesion of proteins or bacteria on the tube surface in vitro and in a 9-month prospective follow-up study. This study was continued until all tubes were extruded. STUDY DESIGN: A prospective, clinical trial. METHODS: The randomized, double-blind clinical trial had 149 patients. The randomization was revealed after the follow-up period of 9 months. The number of tube sequelae in ears with human serum albumin (HSA)-coated titanium tympanostomy tubes was compared with the contralateral ears with uncoated, otherwise identical titanium tubes. The follow-up continued until all tubes were extruded, followed by evaluation of each tympanostomized patient. RESULTS: No significant difference between the two tube types emerged after the 9-month follow-up. Among the patients younger than 2 years, one of the three typical bacteria causing acute otitis media (AOM), Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, was found in 45% of all bacterial cultures taken during AOM. However, among patients older than 2, one of these bacteria appeared in 17% of all the bacterial cultures and in 8% of cultures taken during the summer. CONCLUSIONS: After the first 9 follow-up months, no difference was found in the sequelae related to uncoated and HSA-coated tubes. The typical bacteria causing AOM were found less frequently among patients older than 2 years. A profile of tympanostomy patients in Finland will be given.