disilver-oxide and Cerebrospinal-Fluid-Otorrhea

The insertion of tympanostomy tubes is the most common surgical procedure in the world. A major complication of chronic intubation is infectious otorrhea. The present study compares the rate of infectious otorrhea and survival rate of gold-plated silver tubes (GPR) vs. Silver Oxide-Impregnated Silastic Tubes (SPR).. The prospective, randomized clincial trial was conducted with 116 children (59 female, 57 male) aged between 16 and 127 months (median: 51 months). Bilateral insertion of ventilation tubes was performed with SPR on one side and GPR on the other side in all children. The resulting data were compared using 2-tailed Wilcoxon-test.. Out of 116 children, 11 left the study, 26 children finished the study by extrusion of both tubes, 32 children lost one tube and 47 children lost no tube. Total follow-up of GPR and SPR amounted to 703 and 949 months, respectively. Mean survival rate of SPR and GPR was 9.9 +/- 4.6 and 7.0 +/- 3.4 months, respectively (p < 0.001). During the first postoperative week, 13% of children suffered from otorrhea; after the first postoperative week until extrusion of the tubes, otorrhea was observed in 55% of children. The ratio otorrhea/months amounted to 0.046 and 0.05 in SPR and GPR, respectively (p: n. s.).. Survival rate of SPR is significantly longer than compared to GPR. No differences in the otorrhea rate of SPR vs. GPR are detectable. The longer survival rate of SPR seems to be independent of the rate of infectious otorrhea but depends probably on other effects of biocompatibility.

Topics: Anti-Infective Agents; Cerebrospinal Fluid Otorrhea; Child; Child, Preschool; Data Interpretation, Statistical; Dimethylpolysiloxanes; Female; Follow-Up Studies; Gold; Humans; Infant; Male; Middle Ear Ventilation; Oxides; Postoperative Complications; Prospective Studies; Silicones; Silver Compounds; Time Factors

To test the null hypothesis that impregnation of tympanostomy tubes with silver oxide did not alter the rate of postintubation otorrhea.. Multicenter, double-blind, randomized clinical trial.. Rates of postoperative otorrhea during a 1-year study in ears implanted with Silastic tubes compared with contralateral, identical tubes impregnated with silver oxide.. 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.. 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.. Silastic tubes impregnated with silver oxide seem to diminish the incidence of postoperative otorrhea in ears requiring long-term ventilation.

Topics: Anti-Infective Agents; California; Cerebrospinal Fluid Otorrhea; Child; Child, Preschool; Double-Blind Method; Female; Florida; Humans; Incidence; Infant; Male; Middle Ear Ventilation; Oxides; Postoperative Complications; Silicone Elastomers; Silver Compounds