Randomized and controled trial in rabbits of the medialization ability and tissue healing on the vocal cord augmentation with intracordal injection of bacterian cellulosis

• Grant number: 06/00727-4
• Support Opportunities: Regular Research Grants
• Start date: September 01, 2006
• End date: August 31, 2007
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Henrique Olavo de Olival Costa
• Grantee: Henrique Olavo de Olival Costa
• Host Institution: Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP). Fundação Arnaldo Vieira de Carvalho. São Paulo , SP, Brazil

Abstract

There are several methods of treatment of the vocal folds paralysis, the choice will depend on the conditions of the paralysis and can be from the surgery to the phonotherapy. In some cases, the voice can return without treatment during the first year after the appearance of the paralysis. Therefore, many times the surgical procedure is postponed in the hope of a spontaneous recovery. In some opportunities, the period of wait of one year can be very painful for the bearer of the paralysis, be for the social limitation or or due to the professional embarassement it can produce. Therefore, the possibility to use a technique to bring the benefits of a temporary medialization, without impinging definitive local repercussions could be valuable for these patient. Bionext ® is a cellulose membrane that presents little immunological reactivity and when fragmented tends to stay at the place of the placement without, however, to provoke adverse tissue reaction. These characteristics could make it usefull, mainly in those patient that can have their paralysis reverted with elapsing of the time. The use of a material with these properties still was not investigated properly in patients submitted to medialization by injection for volume increase. As the tests in animals didn't include its evaluation in the area of interest, we understood that it is necessary to verify the inflammatory answer of the receiver, as well as the degree of reabsorption of Bionext ®, to evaluate its usefulness as material of laryngeal reconstruction. Objective: To compare the medialization and the inflammatory answer of vocal folds of rabbits, with and without Bionext ®'s injected intracordaly. Material and method: 62 rabbits will be studied, divided in study group and control. The animals will be followed for up to 4 months, being contained in periods of different continuation so that we can have information as the possible modifications due to the passing of the time. The animals will receive infiltration of paste of Bionext or distilled water, under general anesthesia, and through laringofissure. After the study period the whole glottis, from the ventricle to 1 cm below the glottis free edge will be submitted to histological exam. The inflammatory conditions and the cicatrization degree and fibrose found in each specimen will be appraised. The medialization will be appraised by flexible endoscopy at the end of each continuation period. (AU)