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

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. 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. 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. The closure of perforations was similar in both groups. The average operation time in the fascia group was 76.50min versus 14.06min 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). 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.