Albumin-Coated Tympanostomy Tubes: Prospective, Double-Blind Clinical Study

Objectives: 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)...

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Bibliographic Details
Published in:The Laryngoscope 2004-11, Vol.114 (11), p.2038-2043
Main Authors: Kinnari, Teemu J., Rihkanen, Heikki, Laine, Timo, Salonen, Eeva-Marjatta, Jero, Jussi
Format: Article
Language:English
Subjects:
Adolescent
Albumin coating
Albumins
Biological and medical sciences
Child
Child, Preschool
Double-Blind Method
Ear, auditive nerve, cochleovestibular tract, facial nerve: diseases, semeiology
Equipment Design
Female
Humans
Infant
Male
Medical sciences
Middle Ear Ventilation - instrumentation
Non tumoral diseases
Otorhinolaryngology. Stomatology
otorrhea
Prospective Studies
sequelae
tube occlusion
tympanostomy tube
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Summary:Objectives: 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. Study Design: 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.
ISSN:0023-852X
1531-4995
DOI:10.1097/01.mlg.0000147944.20676.17