Albumin-coated tympanostomy tubes: prospective, double-blind clinical study.
OBJECTIVE
Coating an implant with albumin prevents adhesion of proteins, bacteria, and platelets and thus may lead to its improved and prolonged function. Previously, we have demonstrated the inhibition of binding of fibronectin, one of the most adhesive glycoproteins, on human serum albumin (HSA)-coated tympanostomy tubes and the durability of this binding inhibition in a 8-month trial. We have also demonstrated that the HSA coating inhibits the binding of Staphylococcus aureus and Pseudomonas aeruginosa to titanium plates. This prospective study evaluated the effect of albumin coating on tympanostomy tube sequelae and on the outcome of tympanostomized patients.


METHODS
Double-blind, prospective, randomized clinical trial.


METHODS
Two otolaryngological centers in southern Finland enrolled 179 pediatric patients. Number of tube occlusions and otorrhea and tube ventilation time in the ears with HSA-coated titanium tympanostomy tubes were compared with the contralateral ear with its uncoated, otherwise identical titanium tube during a 9-month follow-up period.


RESULTS
In HSA-coated tubes, average ventilation time was slightly longer and the number of early tube occlusions significantly less (P < .05). Moreover, in patients with perioperative bleeding, the coating prolonged average ventilation time of tympanostomy tubes significantly (P < .05).


CONCLUSIONS
HSA coating reduces early tube occlusions by preventing adherence of blood and secretion.
Kinnari
Teemu J
TJ
Department of Otolaryngology, Helsinki University Central Hospital and the Haartman Institute, Helsinki, Finland. teemu.kinnari@hus.fi
Rihkanen
Heikki
H
Laine
Timo
T
Salonen
Eeva-Marjatta
EM
Jero
Jussi
J
D000293:Adolescent; D000418:Albumins; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004867:Equipment Design; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008876:Middle Ear Ventilation / Q000295:instrumentation*; D011446:Prospective Studies
D000418:Albumins