Background: In 2009, Kanemaru described a new concept of a minimally invasive tympanic membrane repair utilising bFGF (basic fibroblast growth factor), fibrin glue (Tisseel) and a gelatin foam (Gelfoam) scaffold. He recently published a 98% success rate using this technique on 53 patients. We report on our early experiences using his concept in adult and paediatric patients in Western Australia.
Objectives: To describe the scientific background and technique for regenerating the tympanic membrane of patients with chronic perforations utilising the tissue growth factor method devised by Kanemaru, and to report on the pilot study in Australia to validate and prove the safety of the Kanemaru technique.
Method: Adult and paediatric patients with chronic, dry tympanic membrane perforations undergo otoscopic and audiologic assessment to assess candidacy for the trial. After inclusion, the patients undergo the repair, which involves freshening of the perforation followed by the insertion of a gel foam plug soaked with genetically engineered bFGF; the gel foam plug is then covered by commercially available fibrin glue (tisseel) to provide a waterproof seal. The tympanic membranes and their healing are monitored otoscopically and audiologically at one, two, four, eight and twelve weeks after the repair.
Results: 60 patients enrolled in the study, 88% attained a perforation closure with a 3-layered neotympanone and audiologic improvement of hearing. Failures were related to postoperative water exposure; pre-existing middle ear infection and URTI post procedure. Mean operating time for the paediatric patients was six minutes (range three to ten minutes) under general anaesthetic and seven minutes in the adult patients (range four to ten minutes) under local anaesthetic.
Conclusion: The outcomes of the pilot study are promising with regard to closure rates, hearing outcomes and operating times. The advantages of this procedure are that it avoids invasive incisions, is possible in the majority of tympanic membrane perforations and is a short five to ten minute procedure.The next phase involves combining the bFGF with various scaffolds and compare outcomes and cost-efficiency.
