A prospective controlled trial comparing spontaneous closure and Epifilm® patching in traumatic tympanic membrane perforations

Abstract

The objective was to compare the outcomes of spontaneous closure and hyaluronic acid (HA) ester patching (Epifilm®) in subjects with traumatic tympanic membrane (TM) perforation. This was a prospective, controlled study performed at a tertiary teaching and research hospital. During 6-month period, subjects were divided into spontaneous closure (group A) and HA ester patch-Epifilm® (group B) group. Demographic data, presenting symptoms, closure rate, closure time and audiometric data were evaluated and compared between groups. In total, 155 subjects were evaluated. Group A consisted of 62.6 % (n = 97) of the subjects, whereas group B consisted of 37.4 % (n = 58) of the subjects. Group B had significantly shorter closure times when compared with group A (6.61 ± 4.59 vs. 10.60 ± 5.23 weeks, p = 0.001). When the closure time was evaluated according to perforation size both grade 1 and 2 perforations have significantly shorter closure times when compared with group A (6.33 ± 4.54 vs. 10.80 ± 5.69 weeks, for grade 1 and 6.650 ± 2.07 vs. 10.30 ± 4.32 weeks for grade 2 perforations). Closure rates were not significant between groups (85.6 % for group A and 94.8 % for group B). When the closure rate was evaluated according to perforation size no significant difference exists for grade 1, 2 and 3 perforations between groups. Both air conduction and air-bone gap were significantly improved in both groups. HA ester patch (Epifilm®) is a non-toxic material that can be used in traumatic tympanic membrane perforations. In this study, use of HA ester patching was resulted with earlier closure time but not resulted with higher closure rates.

Management of traumatic tympanic membrane perforation: a comparative study

“…Surgical treatment is indicated if TM perforations are symptomatic and large. A prospective, nonrandom study by Sayin et al demonstrated that there was a spontaneous healing rate of 85.6% among 97 patients with TM perforations (59.8% small, 36.1% middle, and 4.1% large perforations) 9. In this study, we showed that the differences between the overall healing and spontaneous healing rates were statistically significant in the control group.…”

Topical application of epidermal growth factor with no scaffold material on the healing of human traumatic tympanic membrane perforations

“…Most traumatic TMPs heal spontaneously; however, the closure time can be very long (3–12 weeks) . To restore patient quality of life more quickly, a few otologists suggest that early myringoplasty accelerates the closure of TMPs In recent years, polypeptide growth factors (e.g. basic fibroblast growth factor, bFGF, and epidermal growth factor, EGF) have been used frequently to repair experimental and clinical TMPs with satisfactory results …”

Spontaneous closure of traumatic tympanic membrane perforations: observational study

“…6,7 Studies comparing outcomes after observation only versus different active surgical interventions using various techniques have shown spontaneous closure rates between 53 and 86 per cent in the observation only groups, 8 and closure rates between 88 and 100 per cent in the operated groups. 2,6,9,10 However, different observation times were used in the various studies.…”