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La película sellante de Tissuemed, TissuePatchDural es "alentadora" en la prevención de derrames CSF


News provided by

Tissuemed Ltd

Jan 31, 2012, 04:00 ET

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LEEDS, Inglaterra, January 31, 2012 /PRNewswire/ --

  • Un nuevo estudio clínico encuentra el uso de la película sellante de Tissuemed, TissuePatchDural como "alentador" en la prevención de derrames CSF

La compañía de película selladora quirúrgica de Reino Unido, Tissuemed Ltd., ha anunciado la publicación de un nuevo artículo clínico en World Neurosurgery relacionado con sus productos de películas selladoras auto-adhesivos.

Se trata de un detallado estudio retrospectivo de un centro único en 119 pacientes que recibieron neurocirugía electiva, realizado por el doctor Paolo Ferroli, el profesor Giovanni Broggi y trabajadores del Carlo Besta Institute, Milán. Todos los pacientes recibieron TissuePatchDural para reforzar el cierre dural tras la identificación de un derrame CSF después de un cierre de microsutura de rutina.

Se realizó en una población mixta de pacientes incluyendo 22 valorados como de alto riesgo por razones como una cirugía anterior, radioterapia, uso de corticosteroides durante largo plazo e hidrocefalia. Los pacientes supratentoriales, infratentoriales y espinales también fueron incluidos. En general los derrames CSF fueron detectados en 11 de los 119 pacientes (9,2%), ocurriendo a las dos semanas de la cirugía. Los pacientes fueron valorados adicionalmente a los 2 y 6 meses tras el tratamiento y no se encontró que padeciese escape CSF. En los 22 pacientes considerados de alto riesgo hubo un mayor porcentaje (36,3%) de derrames CSF, en comparación a un índice de escape del 3,1% en 97 casos sin riesgo adicional. Todos los derrames fueron tratados de manera conservadora y ningún paciente necesitó readmisión o repetición de la cirugía. En conclusión, los autores comentaron "en nuestra experiencia el producto parece ser seguro y sin reacciones adversas evidentes durante todo el estudio. Los resultados en términos de prevención del derrame CSF son prometedores."

El doctor David Mandley, consejero delegado de Tissuemed, comentó: "Este último artículo, el tercero en 12 meses publicado por neurocirujanos europeos, representa el mayor cohorte de pacientes con TissuePatchDural para ser investigado e informado hasta la fecha. A medida que nos acercamos a los cuatro años desde el lanzamiento de TissuePatchDural estoy encantado de tener esta experiencia clínica positiva y haber publicado datos del Carlo Besta Institute, un famoso centro de excelencia en el campo de la neurocirigía."

Acerca de TissuePatchDural

La tecnología empleada en los productos TissuePatch se basa en la unión in-situ de polímeros sintéticos a los tejidos corporales.  Los productos son una capa fina, sintética, unida por enlace covalente a grupos amino en la superficie de los tejidos internos para proporcionar un sellado hermético.  Dichas capas son usadas como un accesorio a la sutura tradicional o grapado en una variedad de procedimientos quirúrgicos donde es primordial conseguir un cierre seguro.

Los datos también confirman el uso del producto hermano de TissuePatchDural, ObexNeurofilm™, que se distribuye por Neurosurgical Technologies Division de Medtronic.

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