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Tympanic Membrane Regeneration Therapy for Pediatric Tympanic Membrane Perforation
Shin-Ichi Kanemaru, Shin-Ichiro Kita1, Rie Kanai1
1Department of Otolaryngology and HNS, Hearing Disturbance and Eardrum Regeneration Center, Medical Research Institute, Kitano Hospital, Public Interest Incorporated Foundation, Tazuke Kofukai, Osaka, Japan.
Insights
Tympanic membrane regeneration therapy (TMRT) effectively healed pediatric tympanic membrane perforations (TMPs) in 90.5% of cases. This novel treatment offers superior hearing improvement compared to traditional surgery for children.
Area of Science:
- Otolaryngology
- Regenerative Medicine
- Pediatric Surgery
Background:
- Pediatric tympanic membrane perforations (TMPs) can lead to hearing loss and require effective treatment.
- Traditional surgical interventions like myringoplasty/tympanoplasty have varying success rates.
Purpose of the Study:
- To evaluate the efficacy of tympanic membrane regeneration therapy (TMRT) for treating pediatric chronic TMPs.
- To compare TMRT outcomes with conventional surgical methods.
Main Methods:
- An intervention study involving 20 pediatric patients with chronic TMPs treated with TMRT.
- A control group of 20 pediatric patients who underwent myringoplasty/tympanoplasty.
- TMRT involved mechanical disruption of the perforation edge, application of gelatin sponge with basic fibroblast growth factor, and fibrin glue, repeated up to four times.
Main Results:
- Tympanic membrane regeneration achieved a final closure rate of 90.5% (19/21 cases), with all cases showing TM regeneration.
- Significant hearing improvement was observed, with the air-bone (AB) gap improving from 12.9 dB to 5.2 dB in the TMRT group.
- The TMRT group demonstrated significantly better AB gap improvement compared to the myringoplasty/tympanoplasty group, with no adverse events reported.
Conclusions:
- Tympanic membrane regeneration therapy (TMRT) is an effective treatment for pediatric chronic TMPs, achieving high closure rates.
- TMRT promotes near-normal tympanic membrane regeneration and superior hearing improvement versus traditional surgery.
- The therapy is a promising option for children with a long life expectancy requiring TM repair.
Objective:
To evaluate tympanic membrane regeneration therapy (TMRT) for pediatric tympanic membrane perforations (TMPs).
Study Design:
Intervention study.
Setting:
Research institute hospital.
Patients:
In this study, 20 patients with chronic TMP (M/F: 13/7, 13/8 ears, age 0-15 years) treated with TMRT were evaluated. As comparison, 20 pediatric patients with chronic TMP who underwent myringoplasty/tympanoplasty were included.
Interventions:
For the TM repair procedure, the edge of the TMP was disrupted mechanically, and gelatin sponge immersed in basic fibroblast growth factor was placed inside and outside the tympanic cavity and covered with fibrin glue. The TMP was examined 4 ± 1 weeks later. The protocol was repeated up to four times until closure was complete.
Main Outcome Measures:
Closure of the TMP and hearing improvement were evaluated at 16 weeks after the final regenerative procedure. Adverse events were monitored.
Results:
The mean follow-up period was 427.1 days. The TM regenerated in all cases, but pinhole reperforation occurred in two cases, and the final closure rate was 90.5% (19 of 21). Hearing improved to 24.9 ± 7.6 dB on average before surgery and to 13.8 ± 5.4 dB after surgery. The AB gap improved from 12.9 ± 8.0 to 5.2 ± 3.5 dB.The myringoplasty/tympanoplasty group had significantly lower AB gap improvement compared with the TMRT group. There were no adverse events.
Conclusions:
TMRT can be expected to regenerate near-normal TMs with a high closure ratio, resulting in better-hearing improvement compared with the myringoplasty/tympanoplasty group, and is an effective treatment for children with long life expectancy.
