Antimicrobial activity of silastic tympanostomy tubes impregnated with silver oxide. A double-blind randomized multicenter trial.
OBJECTIVE
To test the null hypothesis that impregnation of tympanostomy tubes with silver oxide did not alter the rate of postintubation otorrhea.


METHODS
Multicenter, double-blind, randomized clinical trial.


METHODS
Rates of postoperative otorrhea during a 1-year study in ears implanted with Silastic tubes compared with contralateral, identical tubes impregnated with silver oxide.


METHODS
Eight sites in the United States, 125 children aged 1.5 months to 12 years who had bilateral otitis media with effusion or bilateral recurrent acute otitis media.


RESULTS
The overall incidence of postoperative otorrhea was 9.78% in the control ears and 5.08% in the ears with silver oxide-impregnated tubes (P = .01), but no effect was seen during the immediate postoperative period. Granulation tissue was seen adjacent to the tube during two visits in the ears with standard tubes (0.54%) and during two visits in the ears with experimental tubes (0.53%); cholesteatomas did not occur in either group.


CONCLUSIONS
Silastic tubes impregnated with silver oxide seem to diminish the incidence of postoperative otorrhea in ears requiring long-term ventilation.
Chole
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RA
Department of Otolaryngology, University of California-Davis, School of Medicine, USA.
Hubbell
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RN
D000890:Anti-Infective Agents / Q000008:administration & dosage*; D002140:California / Q000453:epidemiology; D002558:Cerebrospinal Fluid Otorrhea / Q000453:epidemiology / Q000517:prevention & control; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005431:Florida / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D008876:Middle Ear Ventilation / Q000295:instrumentation / Q000379:methods; D010087:Oxides / Q000008:administration & dosage*; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control; D012826:Silicone Elastomers; D018030:Silver Compounds / Q000008:administration & dosage*
D000890:Anti-Infective Agents; D010087:Oxides; D012826:Silicone Elastomers; D018030:Silver Compounds; C040225:disilver oxide