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A Double-blind Randomized Multicenter Trial

Richard A. Chole, MD, PhD; Richard N. Hubbell, MD

Arch Otolaryngol Head Neck Surg. 1995;121(5):562-565.

Abstract
Objective
To test the null hypothesis that impregnation of tympanostomy tubes with silver oxide did not alter the rate of postintubation otorrhea.

Design
Multicenter, double-blind, randomized clinical trial.

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

Setting and Participants
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.

Conclusion
Silastic tubes impregnated with silver oxide seem to diminish the incidence of postoperative otorrhea in ears requiring long-term ventilation.

(Arch Otolaryngol Head Neck Surg. 1995;121:562-565)

Author Affiliations
From the Department of Otolaryngology, University of California—Davis, School of Medicine (Dr Chole); and the Department of Otolaryngology, University of Vermont, Burlington (Dr Hubbell).

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