Treatment of tympanic membrane perforation using bacterial cellulose: a randomized controlled trial

Fábio Coelho Alves Silveira, Flávia Cristina Morone Pinto, Sílvio da Silva Caldas Neto, Mariana de Carvalho Leal, Jéssica Cesário, José Lamartine de Andrade Aguiar, Fábio Coelho Alves Silveira, Flávia Cristina Morone Pinto, Sílvio da Silva Caldas Neto, Mariana de Carvalho Leal, Jéssica Cesário, José Lamartine de Andrade Aguiar

Abstract

Introduction: Promising treatments for tympanic membrane perforation closure have been studied. Therapies derived from tissue engineering probably eliminate the need for conventional surgery. Bacterial cellulose is presented as an alternative that is safe, biocompatible, and has low toxicity.

Objectives: To investigate the effect on healing of direct application of a bacterial cellulose graft on the tympanic membrane compared to the conventional approach with autologous fascia.

Methods: Randomized controlled trial. Forty patients with tympanic membrane perforations secondary to chronic otitis media were included, and were randomly assigned to an experimental group (20), treated with a bacterial cellulose graft (BC) and control group (20), treated with autologous temporal fascia (fascia). We evaluated the surgical time, hospital stay, time of epithelialization and the rate of tympanic perforation closure. Hospital costs were compared. The statistical significance level accepted was established at p<0.05.

Results: The closure of perforations was similar in both groups. The average operation time in the fascia group was 76.50 min versus 14.06 min bacterial cellulose in the group (p=0.0001). The hospital cost by the Brazilian public health system was R$ 600.00 for the bacterial cellulose group, and R$ 7778.00 for the fascia group (p=0.0001).

Conclusion: Bacterial cellulose grafts promoted the closure of the tympanic membrane perforations, and were demonstrated to be innovative, effective, safe, minimally invasive, efficacious and to have a very low cost.

Keywords: Bacterial cellulose; Biopolymer; Biopolímero; Celulose bacteriana; Perfuração da membrana timpânica; Tympanic membrane perforation.

Copyright © 2015 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Figures

Figure 1
Figure 1
Tympanic perforation on otomicroscopy.
Figure 2
Figure 2
Otoendoscopy of bacterial cellulose graft over TMP.
Figure 3
Figure 3
Tympanic membrane after application of bacterial cellulose graft, on microscopic examination.
Figure 4
Figure 4
Relationship between material's success and failure versus procedure time.

References

    1. Kanemaru S., Umeda H., Kitani Y., Nakamura T., Hirano S., Ito J. Regenerative treatment for tympanic membrane perforation. Otol Neurotol. 2011;32:1218–1223.
    1. Zhang Q., Lou Z. Impact of basic fibroblast growth factor on healing of tympanic membrane perforations due to direct penetrating trauma: a prospective non-blinded/controlled study. Clin Otolaryngol. 2012;37:446–451.
    1. Lou Z., Xu L., Yang J., Wu X. 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. 2011;75:1285–1288.
    1. Hakuba N., Hato N., Okada M., Mise K., Gyo K. Tympanic membrane regeneration therapy. JAMA Otolaryngol Head Neck Surg. 2014;23:E1–E7.
    1. Kakehata S., Hirose Y., Kitani R., Futai K., Maruya S., Ishii K., et al. Autologous serum eardrops therapy with a chitin membrane for closing tympanic membrane perforations. Otol Neurotol. 2008;29:791–795.
    1. Castro C.M.M.B., Aguiar J.L.A., Melo F.A.D., Silva W.T.F., Marques E., Silva D.B. Sugar cane biopolymer cytotoxicity. An Fac Med Univ Fed Pernamb. 2004;49:119–123.
    1. Lucena M.T., Melo Júnior M.R., Lira M.M.M., Castro C.M., Cavalcanti L.A., Menezes M.A., et al. Biocompatibility and cutaneous reactivity of cellulosic polysaccharide film in induced skin wounds in rats. J Mater Sci Mater Med. 2015;26 doi: 10.1007/s10856-015-5410-x.
    1. Fragoso A.S., Silva M.B., de Melo C.P., Aguiar J.L.A., Rodrigues C.G., de Medeiros P.L., et al. Dielectric study of the adhesion of mesenchymal stem cells from human umbilical cord on a sugarcane biopolymer. J Mater Sci Mater Med. 2014;25:229–237.
    1. Teixeira F.M.F., Pereira M.F., Ferreira N.L.G., Miranda G.M., Aguiar J.L.A. Spongy film of cellulosic polysaccharide as a dressing for aphthous stomatitis treatment in rabbits. Acta Cir Bras. 2014;29:231–236.
    1. Martins A.G.S., Lima S.V.C., Araujo L.A.P., Vilar F.O., Cavalcante N.T.P.A. Wet dressing for hypospadias surgery. Int Braz J Urol. 2013;39:408–413.
    1. Silva D.B., Aguiar J.L.A., Marques A., Coelho A.R.B., Rolim Filho E.L. Miringoplastia com enxerto livre de membrana de polímero da cana-de-açúcar e fáscia autóloga em Chinchillalaniger. An Fac Med Univ Fed Pernamb. 2006;51:45–55. Available at: [accessed on 14.08.2014]
    1. ASHA, American Speech-Language-Hearing Association Guidelines for screening for hearing impairment and middle-ear disorders. Working Group on Acoustic Immittance Measurements and the Committee on Audiologic Evaluation. ASHA. 1990;Suppl.:17–24.
    1. Bhat N.A., Ranit De Retrospective analysis of surgical outcome, symptom changes, and hearing improvement following myringoplasty. J Otol. 2000;29:229–232.
    1. Fukuchi I., Cerchiari D.P., Garcia E., Rezende C.E.B., Rapoport P.B. Timpanoplastias: resultados cirúrgicos e análise dos fatores que podem interferir no seu sucesso. Braz J Otorhinolaryngol. 2006;72:267–271.
    1. Spiegel J.H., Kessler J.L. Tympanic membrana perforation repair with acellular porcine submucosa. Otol Neurotol. 2005;26:563–566.
    1. Glasscock M.E., Kanock M.M. Tympanoplasty – a chronological history. Otolaryngol Clin North Am. 1977;10:469–477.
    1. Shanks J., Shelton C., Basic Principles Clinical application of tympanometry. Otolaryngol Clin North Am. 1991;24:299–328.
    1. Oliveira J.A.A., Hyppolito M.A., Netto J.C., Mrué F. Miringoplastia com a utilização de um novo material biossintético. Braz J Otorhinolaryngol. 2003;69:138–155.
    1. Cordeiro-Barbosa F.A., Aguiar J.L.A., Lira M.M.M., Pontes Filho N.T., Bernardino-Araújo S. Use of a gel biopolymer for the treatment of eviscerated eyes: experimental model in rabbits. Arq Bras Oftalmol. 2012;75:267–272.

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