[Comparison of gold-plated silver- and silver oxide-impregnated silastic tympanostomy tubes: a randomized, prospective clinical trial].

UNLABELLED

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).

STUDY DESIGN

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.

RESULTS

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.).

CONCLUSIONS

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.