Abstract
Regenerative therapy for closure of tympanic membrane (TM) perforation using basic fibroblast growth factor and atelocollagen/silicone bilayer was conducted at the outpatient clinic of Ehime University Hospital. In total, 140 cases (45 males and 95 females; mean age, 64.8 years; range, 13-90 years) had undergone a day surgery from July 2009 to August 2011.
The complete closure rate was 83.6% in 3 months after surgery and 67.1% > 1 year after surgery. The complete closure rate according to the original size of the perforation was 71.6% for a small perforation, 68.6% for a mid-sized perforation and 50.0% for a large perforation. Additionally, the mean number of trials until complete closure in 94 cases was 1.38 times.
Closure of TM perforation was significantly harder to conduct regeneration therapy when the entire perforation edge was invisible because of bulging of the external auditory meatus, when eardrum calcification was remarkable, and when the perforation edge was close to the tympanic annulus.
Eighteen of 140 (12.9%) cases that showed aural discharge after surgery were thought to be due to postoperative infection. Postoperative epithelial pearls were found in 7 (5.0%) cases, which was a similar rate to the incidence of postoperative epithelial pearls following conventional myringoplasty. In a case in which atelocollagen soaked with bFGF was depressed into the middle ear cavity, the regenerated eardrum adhered to the middle ear muca and inflamed fibrous tissue was observed in the adhesion area. As the safety of bFGF on the middle ear mucosa has not been established, preparation for regenerative ear drum therapy; thus, it should be used not to flow the middle ear cavity.