Epidermal Growth Factor Application versus Observation on Healing of Acute Tympanic Membrane Perforations: A Randomized Open Label Clinical Trial

Abstract

ABSTRACT Objective: To compare the effect of topical epidermal growth factor (EGF) instillation versus observation alone on healing of acute tympanic membrane perforations in terms of closure and hearing test results. Methods:  Design: Randomized, Open label, Clinical Trial Setting: Tertiary Government Training Hospital Participants: Seventeen (17) ENT-HNS OPD patients aged between 18 to 65 years old diagnosed with acute tympanic membrane perforation were included in the study. Group A underwent observation while group B was treated with recombinant human EGF solution. Follow- up was on a weekly basis (7th, 14th, 21st and 28th days) where video otoscopy for documentation and measurement of perforation using ImageJTM software was done. Pure tone audiometry was used to compare hearing improvement pre and post study in both observation and treatment groups. Results: At baseline, there was no significant difference in the sizes of perforations: 24.20 ± 9.95 (treatment) vs. 32.64 ± 11.62 (observation) with a p-value of .131. Following treatment, mean changes in perforation size were significantly greater in the treatment group compared to the observation group from baseline to day 7 (M = -9.08, n = 15.11 vs. M = -1.06, n = 31.58); p = .009; day 7 to 14 (M = -6.37, n = 13.78 vs. M = -0.79, n = 30.79); p = .003; and from day 14 to 21 (M = -5.65, n = 10.89 vs. M = -0.72, n = 30.07); p = .004 but not from day 21 to 28 (M = -4.16, n = 13.99 vs. M = -0.36, n = 29.71; p = .021. From baseline pure tone averages, four participants with mild hearing loss and two with moderate hearing loss achieved normal hearing in the treatment group (while one each with moderate and severe hearing loss did not improve). None of the observation group participants had improved hearing. Conclusion: Based on our limited experience, topical EGF can be used for traumatic tympanic membrane perforation and otitis media with dry ear perforation during the acute phase or within 3 months of perforation.