The Laryngoscope C 2016 The American Laryngological, V
Rhinological and Otological Society, Inc.
A Prospective Cohort Study of the Silk Fibroin Patch in Chronic Tympanic Membrane Perforation Jun Ho Lee, MD, PhD; Dong-Kyu Kim, MD; Hae Sang Park, MD; Ju Yeon Jeong, MS; Yeung Kyu Yeon, MS; Vijay Kumar, MS; Sung Hee Bae, MD; Jung Min Lee, MS; Bo Mi Moon, MS; Chan Hum Park, MD, PhD Objectives/Hypothesis: Silk fibroin patching has been used to repair acute tympanic membrane perforations. Here, we describe the advantages and outcomes of this technique for chronic tympanic membrane perforations. Study Design: Individual cohort study. Methods: Forty patients were enrolled; half underwent perichondrium myringoplasty, and the silk fibroin patch technique was applied in the remaining patients. We compared the closure, otorrhea, and complication rates; closure time; postoperative hearing gain; and patient satisfaction between the two groups. Results: Demographic data (gender, site, age, duration, preoperative air-bone gap, and perforation size and location) were not significantly different between the two groups. The closure rates and times, complication rates, and postoperative hearing gains were also similar in both groups. The mean operative time, otorrhea rate, and complication rate were also significantly better in the silk fibroin patch group. The intraoperative dizziness scores were higher in the conventional perichondrium myringoplasty group. Conclusions: Success rates were similar for the silk fibroin patch technique and conventional perichondrium myringoplasty; however, patching was an easier, faster procedure. Our results suggest that the silk fibroin patch technique is a suitable treatment for chronic tympanic membrane perforation. Key Words: Middle ear, tympanic membrane perforation, silk, fibroin. Level of Evidence: 2b Laryngoscope, 126:2798–2803, 2016
INTRODUCTION Chronic tympanic membrane (TM) perforation is frequently seen in otorhinolaryngologic clinics. Conventional myringoplasty was traditionally recommended to address hearing impairment, ear discomfort, and prepare the ear canal for hearing aid placement in mixed hearing loss patients.1 However, myringoplasty is relatively expensive and is associated with perioperative patient discomfort and surgery-related morbidities. It requires a skin incision, which could lead to postoperative problems, including temporal mastication difficulty, hair loss due to shaving, incision site hematoma, stain-
From the Department of Otorhinolaryngology–Head and Neck Surgery (J.H.L., D.-K.K., H.S.P., J.Y.J., Y.K.Y., V.K., S.H.B., C.H.P.), Chuncheon Sacred Heart Hospital, School of Medicine; and the Nano-Bio Regenerative Medical Institute (J.H.L., D.-K.K., H.S.P., J.M.L., B.M.M., D.W.K., C.H.P.), Hallym University, Gangwon, South Korea Editor’s Note: This Manuscript was accepted for publication February 23, 2016. This work was supported by the Hallym University Research Fund and a grant from the Korean Health Technology Research and Development Project (HI13C2268), Ministry of Health and Welfare, Republic of Korea. The authors have no other funding, financial relationships, or conflicts of interest to disclose. Send correspondence to Chan Hum Park, Professor, Department of Otorhinolaryngology–Head and Neck Surgery, Chuncheon Sacred Heart Hospital, School of Medicine, Hallym University, 153, Kyo-Dong, Chuncheon, Gangwon, 200-704, South Korea. E-mail: [email protected]
Laryngoscope 126: December 2016
ing or keroid formation, and extended recovery time.2 If a myringoplasty is performed via a retroauricular approach, compression dressing is also needed. Fat harvested from the ear lobe can be used if the perforation is tiny3; Some authors have reported surgical trials without skin incisions using paper patches4,5 or chemical application using silver nitrate beads on a metal probe or urea ointment patch.6 Recent advances in tissue engineering and biomaterial research have suggested alternative material for TM regeneration.7 Silk, collagen, chitosan, and calcium alginate have been studied as TM patching materials and have shown favorable results in animal and clinical studies of acute traumatic TM perforation.7–9 Among these options, silk fibroin has high biocompatibility and can heal the perforated TM in animal models.10,11 Silk fibroin patches (Tympasil; Daewoong-Bio, Seoul, Korea) are thin transparent patches produced from silk fibroin (Fig. 1). We previously described the mechanical and biomaterial properties of silk fibroin membranes10 and reported animal study results of silk fibroin patching for acute TM perforation.11 Recently, we compared clinical results of silk fibroin and paper patches for repairing acute TM perforations.12 The pathogenesis and histologic condition of perforation margins were different between acute and chronic TM perforation, but healing of the TM perforation margins was similar in acute and chronic cases when the perforation margin was trimmed prior to Lee et al.: Silk Fibroin Patch in Chronic TM Perforation
Fig. 1. (A) The thin transparent silk fibroin patch (Tympasil). (B) The silk patch was softened by immersion in warm saline (378C) for 1 minute. (C) The flexed and softened silk patch was then able to be cut and placed on the perforated tympanic membrane. [Color figure can be viewed in the online issue, which is available at www.laryngoscope.com.]
grafting-material application. In the present study, we investigated the utility of silk fibroin patching in patients with chronic TM perforation.
MATERIALS AND METHODS An individual cohort study was performed using a table of random numbers. From 2014 to 2015, all 40 consecutive patients were managed in the Department of Otolaryngology– Head and Neck surgery, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Republic of Korea, with a diagnosis of chronic TM perforation. The 40 patients received one of two surgical procedures: a conventional perichondrium myringoplasty or a silk fibroin patch technique using a table of random numbers. All of the patients provided written informed consent in accordance with the Declaration of Helsinki of the World Medical Association. The Chuncheon Sacred Heart Hospital institutional review board and Korea Food & Drug Administration approved the following study protocol. All patients satisfying the following criteria were included in this study: perforation present for at least 6 months, no evidence of otorrhea for at least 6 months, no evidence of retraction pocket formation or cholesteatoma, no suspected ossicular problem on microscopic examination, and tympanosclerosis without ossicles involvement. Patients were excluded if there was granulation tissue on the drum, persistent or recent otorrhea