title: Regenerative treatment for tympanic membrane perforation.
abstract: OBJECTIVE
  To establish a tissue engineering therapy for the treatment of large tympanic membrane perforation (TMP) without the need for conventional surgical therapy.
  
  
  METHODS
  Randomized control trial.
  
  
  METHODS
  General hospital.
  
  
  METHODS
  A total of 63 chronic TMPs were randomly selected from outpatients.
  
  
  METHODS
  Of the total 63 chronic TMPs, 53 were randomly assigned to the basic fibroblast growth factor (b-FGF) group and the remaining 10 were randomly assigned to the control group. Materials used for the TM repair were gelatin sponge and fibrin glue with/without b-FGF. After creating a mechanical disruption of the edge of the TMP, a gelatin sponge was immersed in b-FGF or saline (for the control group) and placed over the perforation. Fibrin glue was dripped over the sponge as a sealant.
  
  
  METHODS
  The effectiveness of this therapy was evaluated by closure rates, hearing level, and sequelae 3 weeks after treatment. The treatment was repeated up to 4 times for cases in which complete closure of the TMP was not achieved after 1 round of treatment.
  
  
  RESULTS
  Complete closure of the TMP was achieved in more than 98.1% (52/53) of the patients in the b-FGF group and 10% (1/10) of the patients in the control group. The average hearing level of all patients with successful TM repair was improved. Serious sequelae were not observed in any patient.
  
  
  CONCLUSIONS
  This study demonstrates that a combination of gelatin sponge, b-FGF, and fibrin glue enables the regeneration of the TM without conventional operative procedures. This innovative regenerative therapy is an easy, safe, cost-effective, and minimally invasive outpatient treatment.
authors: Department of Otolaryngology-Head and Neck Surgery, Medical Research Institute, Kitano Hospital, Osaka, Japan. kanemaru@ent.kuhp.kyoto-u.ac.jp
authors: Shin-Ichi
authors: S
authors: Kanemaru
authors: Hiroo
authors: H
authors: Umeda
authors: Yoshiharu
authors: Y
authors: Kitani
authors: Tatsuo
authors: T
authors: Nakamura
authors: Shigeru
authors: S
authors: Hirano
authors: Juichi
authors: J
authors: Ito
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D016222:Fibroblast Growth Factor 2 / Q000627:therapeutic use*; D005780:Gelatin / Q000627:therapeutic use; D034381:Hearing Loss / Q000209:etiology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012038:Regeneration / Q000502:physiology*; D023822:Tissue Engineering / Q000379:methods*; D016896:Treatment Outcome; D014432:Tympanic Membrane / Q000502:physiology*; D018058:Tympanic Membrane Perforation / Q000150:complications / Q000628:therapy*
chemical_list: D015718:Fibrin Tissue Adhesive; D016222:Fibroblast Growth Factor 2; D005780:Gelatin