R A Chole1, R N Hubbell. 1. Department of Otolaryngology, University of California-Davis, School of Medicine, USA.
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.
RCT Entities:
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.
Authors: Sarah S Goderecci; Eric Kaiser; Michael Yanakas; Zachary Norris; Jeffrey Scaturro; Robert Oszust; Clarence D Medina; Fallon Waechter; Min Heon; Robert R Krchnavek; Lei Yu; Samuel E Lofland; Renee M Demarest; Gregory A Caputo; Jeffrey D Hettinger Journal: Molecules Date: 2017-09-07 Impact factor: 4.411