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Antimicrobial Activity of Silastic Tympanostomy Tubes Impregnated With Silver Oxide: A Double-blind Randomized Multicenter Trial

1995; American Medical Association; Volume: 121; Issue: 5 Linguagem: Inglês

10.1001/archotol.1995.01890050054010

1538-361X

Richard A. Chole, Richard N. Hubbell,

Respiratory and Cough-Related Research

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)