Shin-ichi Kanemaru1, Hiroo Umeda, Rie Kanai, Takuya Tsuji, Fumiko Kuboshima, Misaki Yamamoto, Shigeru Hirano, Tatsuo Nakamura. 1. *Department of Otolaryngology, The Foundation for Biomedical Research and Innovation, Kobe; †Department of Otolaryngology-Head and Neck Surgery, Medical Research Institute, Kitano Hospital, Osaka; ‡Department of Otolaryngology-Head and Neck Surgery, Shizuoka General Hospital, Shiozuoka; §Department of Otolaryngology-Head and Neck Surgery, Graduate School of Medicine, Kyoto University; and ∥Department of Bioartificial Organs, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan.
Abstract
OBJECTIVE: To establish a regenerative treatment for soft tissue defects of the external auditory meatus (EAM) without conventional surgical therapy. STUDY DESIGN: Controlled clinical pilot study. SETTING: General hospitals. PATIENTS: Sixty-five patients with new or old EAM defects without active inflammation were selected. Ages ranged from 12 to 87 years (average age of 58 yr). INTERVENTION: Therapeutic nonsurgical treatment of EAM defects. Gelatin sponge, basic fibroblast growth factor (b-FGF), fibrin glue, and water proof transparent dressing were used in the repair procedure. Patients were divided into 2 groups: treatment with (n = 54) and without (n = 11) b-FGF. After mechanically disrupting the edge of the EAM defect, gelatin sponge immersed in b-FGF was placed over the defect and covered with fibrin glue. In cases of extensive EAM defects, the EAM was filled with gelatin sponge/b-FGF, and the auricle was wrapped in water proof dressing. Two or 3 weeks postprocedure, crust over the defect was removed. If complete defect closure was not achieved after 1 treatment course, the treatment was repeated. MAIN OUTCOME MEASURE: Evaluation of complete closure of EAM defects 3 months posttreatment. RESULTS: Complete closure of the EAM defect was achieved within 3 treatment courses in 92.6% (50/54) and 18.2% (2/11) of the patients with or without b-FGF, respectively. No inflammation/infection or severe sequelae were observed. CONCLUSION: This study demonstrated the effectiveness of combining gelatin sponge, b-FGF, and fibrin glue for EAM defect regeneration. This innovative regenerative therapy is an easy, simple, cost-effective and minimally invasive method for treating EAM defects.
OBJECTIVE: To establish a regenerative treatment for soft tissue defects of the external auditory meatus (EAM) without conventional surgical therapy. STUDY DESIGN: Controlled clinical pilot study. SETTING: General hospitals. PATIENTS: Sixty-five patients with new or old EAM defects without active inflammation were selected. Ages ranged from 12 to 87 years (average age of 58 yr). INTERVENTION: Therapeutic nonsurgical treatment of EAM defects. Gelatin sponge, basic fibroblast growth factor (b-FGF), fibrin glue, and water proof transparent dressing were used in the repair procedure. Patients were divided into 2 groups: treatment with (n = 54) and without (n = 11) b-FGF. After mechanically disrupting the edge of the EAM defect, gelatin sponge immersed in b-FGF was placed over the defect and covered with fibrin glue. In cases of extensive EAM defects, the EAM was filled with gelatin sponge/b-FGF, and the auricle was wrapped in water proof dressing. Two or 3 weeks postprocedure, crust over the defect was removed. If complete defect closure was not achieved after 1 treatment course, the treatment was repeated. MAIN OUTCOME MEASURE: Evaluation of complete closure of EAM defects 3 months posttreatment. RESULTS: Complete closure of the EAM defect was achieved within 3 treatment courses in 92.6% (50/54) and 18.2% (2/11) of the patients with or without b-FGF, respectively. No inflammation/infection or severe sequelae were observed. CONCLUSION: This study demonstrated the effectiveness of combining gelatin sponge, b-FGF, and fibrin glue for EAM defect regeneration. This innovative regenerative therapy is an easy, simple, cost-effective and minimally invasive method for treating EAM defects.