European Archives of Oto-Rhino-Laryngology

, Volume 270, Issue 11, pp 2857–2863 | Cite as

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

  • Ibrahim Sayin
  • Kamil Hakan Kaya
  • Oğuzhan Ekizoğlu
  • İbrahim Erdim
  • Fatma Tülin Kayhan


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.


Traumatic Tympanic membrane perforation Spontaneous healing Hyaluronic acid ester Epifilm® Patch 



We would like to thank Emire Bor, EMPIAR Statistical Consultancy, Istanbul, Turkey for performing the statistical analysis.

Conflict of interest

We transfer all copyright ownership of the manuscript to the journal “European Archives of Oto-Rhino-Laryngology and Head & Neck’’. We warrant that the article is original, does not infringe upon any copyright or other proprietary right of any third party. Now the journal is not under consideration by another journal, and has not been previously published. We also have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.


  1. 1.
    Conoyer JM, Kaylie DM, Jackson CG (2007) Otologic surgery following ear trauma. Otolaryngol Head Neck Surg 137(5):757–761CrossRefPubMedGoogle Scholar
  2. 2.
    Lou ZC, Tang YM, Yang J (2011) A prospective study evaluating spontaneous healing of aetiology, size and type-different groups of traumatic tympanic membrane perforation. Clin Otolaryngol 36(5):450–460. doi: 10.1111/j.1749-4486.2011.02387.x CrossRefPubMedGoogle Scholar
  3. 3.
    Orji FT, Agu CC (2008) Determinants of spontaneous healing in traumatic perforations of the tympanic membrane. Clin Otolaryngol 33(5):420–426CrossRefPubMedGoogle Scholar
  4. 4.
    Amadasun JE (2002) An observational study of the management of traumatic tympanic membrane perforations. J Laryngol Otol 116(3):181–184CrossRefPubMedGoogle Scholar
  5. 5.
    Lou ZC, He JG (2011) A randomised controlled trial comparing spontaneous healing, gelfoam patching and edge-approximation plus gelfoam patching in traumatic tympanic membrane perforation with inverted or everted edges. Clin Otolaryngol 36(3):221–226. doi: 10.1111/j.1749-4486.2011.02319.x CrossRefPubMedGoogle Scholar
  6. 6.
    Kim J, Kim CH, Park CH et al (2010) Comparison of methods for the repair of acute tympanic membrane perforations: Silk patch vs. paper patch. Wound Repair Regen 18(1):132–138CrossRefPubMedGoogle Scholar
  7. 7.
    Park MK, Kim KH, Lee JD, Lee BD (2011) Repair of large traumatic tympanic membrane perforation with a Steri-Strips patch. Otolaryngol Head Neck Surg 145(4):581–585 [Epub 2011 May 18]CrossRefPubMedGoogle Scholar
  8. 8.
    Güneri EA, Tekin S, Yilmaz O et al (2003) The effects of hyaluronic acid, epidermal growth factor, and mitomycin in an experimental model of acute traumatic tympanic membrane perforation. Otol Neurotol. 24(3):371–376CrossRefPubMedGoogle Scholar
  9. 9.
    Saliba I, Froehlich P (2011) Hyaluronic acid fat graft myringoplasty: an office-based technique adapted to children. Arch Otolaryngol Head Neck Surg 137(12):1203–1209CrossRefPubMedGoogle Scholar
  10. 10.
    Park AH, Hughes CW, Jackson A et al (2006) Crosslinked hydrogels for tympanic membrane repair. Otolaryngol Head Neck Surg 135(6):877–883CrossRefPubMedGoogle Scholar
  11. 11.
    Saliba I (2008) Hyaluronic acid fat graft myringoplasty: how we do it. Clin Otolaryngol 33(6):610–614CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Ritenour AE, Wickley A, Ritenour JS et al (2008) Tympanic membrane perforation and hearing loss from blast overpressure in Operation Enduring Freedom and Operation Iraqi Freedom wounded. J Trauma 64(2 Suppl):S174–S178 (discussion S178)CrossRefPubMedGoogle Scholar
  13. 13.
    Lou Z, Xu L, Yang J, Wu X (2011) Outcome of children with edge-everted traumatic tympanic membrane perforations following spontaneous healing versus fibroblast growth factor-containing gelfoam patching with or without edge repair. Int J Pediatr Otorhinolaryngol 75(10):1285–1288 [Epub 2011 Aug 9]CrossRefPubMedGoogle Scholar
  14. 14.
    Prior M, Gibbins N, John G, Rhys-Williams S, Scott P (2008) Hyaluronic acid ester in myringoplasty. J Laryngol Otol 122(2):e3 [Epub 2007 Dec 21]CrossRefPubMedGoogle Scholar
  15. 15.
    Saliba I, Woods O (2011) Hyaluronic acid fat graft myringoplasty: a minimally invasive technique. Laryngoscope 121(2):375–380. doi: 10.1002/lary.21365.Epub.2011.Jan.13 CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  • Ibrahim Sayin
    • 1
  • Kamil Hakan Kaya
    • 1
  • Oğuzhan Ekizoğlu
    • 2
  • İbrahim Erdim
    • 1
  • Fatma Tülin Kayhan
    • 1
  1. 1.ENT ClinicBakırköy Dr. Sadi Konuk Teaching and Research HospitalIstanbulTurkey
  2. 2.Forensic Science DepartmentBakırköy Dr. Sadi Konuk Teaching and Research HospitalIstanbulTurkey

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