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.


METHODS
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.
Kinnari
Teemu J
TJ
Department of Otolaryngology, Helsinki University Central Hospital and Haartman Institute, Helsinki, Finland. teemu.j.kinnari@helsinki.fi
Rihkanen
Heikki
H
Laine
Timo
T
Salonen
Eeva-Marjatta
EM
Jero
Jussi
J
D000208:Acute Disease; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D020099:Coated Materials, Biocompatible; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D008876:Middle Ear Ventilation / Q000295:instrumentation*; D010033:Otitis Media / Q000601:surgery*; D011446:Prospective Studies; D011474:Prosthesis Design; D012709:Serum Albumin / Q000494:pharmacology*; D013997:Time Factors; D014025:Titanium; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D012709:Serum Albumin; D014025:Titanium