Role of Albumin Coating of Tympanostomy Tubes: Long‐Term Clinical Evaluation

Abstract 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.