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 tympanosto my tubes with silver oxide did not alter the rate of postintubation ot orrhea. 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, id entical 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 recurr ent acute otitis media. Results: The overall incidence of postoperativ e otorrhea was 9.78% in the control ears and 5.08% in the ears with Si lver oxide-impregnated tubes (P=.01), but no effect was seen during th e 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%); ch olesteatomas did not occur in either group. Conclusion: Silastic tubes impregnated with silver oxide seem to diminish the incidence of posto perative otorrhea in ears requiring long-term ventilation.