Abstract
ObjectiveTo evaluate the efficacy and safety of regenerative treatment for tympanic membrane perforation (TMP) using gelatin sponge, basic fibroblast growth factor (bFGF), and fibrin glue. MethodsThis was a multicenter, non-randomized, single-arm study conducted at tertiary referral centers. Twenty patients with chronic TMP (age 23–78 years, 6 males, 14 females) were registered from three institutions. All treated patients were included in the safety analysis population. The edges of the TMP were disrupted mechanically by myringotomy and several pieces of gelatin sponge immersed in bFGF were placed and fixed with fibrin glue to cover the perforation. The TMP was examined 4 ± 1 weeks later. The protocol was repeated up to four times until closure was complete. The main outcome measures were closure or a decrease in size of the TMP, hearing improvement, and air–bone gap evaluated 16 weeks after the final regenerative procedure (FRP). Adverse events (AEs) were monitored throughout the study. ResultsTotal closure of the TMP at 16 weeks was achieved in 15 out of 20 patients (75.0%, 95% confidence interval [CI]: 50.9%–91.3%) and the mean decrease in size was 92.2% (95%CI: 82.9%–100.0%). The ratio of hearing improvement and the air–bone gap at 16 weeks after FRP were 100% (20/20; 95%CI: 83.2%–100%) and 5.3 ± 4.2 dB (p <0.0001), respectively. Thirteen out of 20 patients (65.0%) experienced at least one AE, but no serious AEs occurred. ConclusionThe results indicate that the current regenerative treatment for TMP using gelatin sponge, bFGF, and fibrin glue is safe and effective.
Highlights
World Health Organization (WHO) statistics estimate that there are more than 150 million patients with tympanic membrane (TM) perforation (TMP) worldwide [1]
The ratio of hearing improvement and the air–bone gap at 16 weeks after final regenerative procedure (FRP) were 100% (20/20; 95%confidence interval (CI): 83.2%–100%) and 5.3 ± 4.2 dB (p
The results indicate that the current regenerative treatment for tympanic membrane perforation (TMP) using gelatin sponge, basic fibroblast growth factor (bFGF), and fibrin glue is safe and effective
Summary
World Health Organization (WHO) statistics estimate that there are more than 150 million patients with tympanic membrane (TM) perforation (TMP) worldwide [1]. Major side effects associated with TMP include hearing loss, reduced discrimination ability, and tinnitus, as well as a sensation of aural fullness. Patients with TMP are at high risk of inner ear infection, which may lead to serious complications including otorrhea and sensorineural hearing loss. The possibility of repair suggests that it might be feasible to close even chronic and large TMPs by providing suitable conditions for growth and regeneration. Tissue engineering studies have indicated that three elements are essential for tissues to regenerate: cells, a scaffold, and regulatory factors, in addition to a suitable environment [6,7,8]. We previously showed that large/total TMPs could be closed by applying the principles of modern in situ tissue engineering, without the need for conventional surgical treatment, with a success rate of >85% and good hearing improvement [9,10]
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