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Inicio Cirugía Española Hemostáticos tópicos en cirugía: entre la ciencia y el marketing
Journal Information
Vol. 85. Issue S1.
Hemoragia, hemostasia y trombosis en cirugía
Pages 23-28 (July 2009)
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Vol. 85. Issue S1.
Hemoragia, hemostasia y trombosis en cirugía
Pages 23-28 (July 2009)
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Hemostáticos tópicos en cirugía: entre la ciencia y el marketing
Topical hemostatic devices in surgery: between science and marketing
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Héctor Daniel Gonzáleza, Joan Figueras Felipa
a Unidad de Cirugía Hepato-bilio-pancreática, Servicio de Cirugía General y Digestiva, Hospital de Girona Dr. Josep Trueta, IdiBGi, Girona, España
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Los agentes hemostáticos tópicos se han venido usando en cirugía con diferentes grados de éxito. Estos agentes incluyen la celulosa oxidada, esponjas de gelatina absorbible, colágeno microfibrilar y sellantes de fibrina. Los sellantes de fibrina se han hecho populares por mejorar la hemostasia perioperatoria, reducir la necesidad de transfusiones de hematíes y prevenir la fuga biliar. Su amplia utilización, sin embargo, contrasta con la escasez de datos a partir de estudios controlados que avalen su eficacia clínica. Por ello se diseñó un estudio prospectivo en un solo centro, aleatorizado, controlado, en 300 pacientes, con y sin la aplicación de un sellante de fibrina sobre la superficie cruenta del hígado, en pacientes sometidos a hepatectomías electivas. Ninguna de las variables evaluadas (pérdidas sanguíneas, transfusiones, fístulas biliares y resultados postoperatorios) fueron diferentes entre los grupos. Concluimos que la aplicación del sellante de fibrina no parece estar justificada y que la interrupción de su uso rutinario supondría una reducción de costes considerable. La utilización del nuevo agente Tachosil® está avalada por un solo ensayo multicéntrico prospectivo, aleatorizado y controlado, cuyas limitaciones vienen dadas por el escaso número de pacientes y por el hecho de que la variable analizada, tiempo desde la aplicación hasta la hemostasia, podría no ser clínicamente relevante.

Palabras clave:
Hemostáticos tópicos
Cirugía
Hemostasia
Coagulación

Topical hemostatic agents have been used in surgery with varying degrees of success. These agents include oxidized cellulose, absorbable gelatin sponges, microfibrillar collagen and fibrin seals. Fibrin seals have become widely used as they improve perioperative hemostasis, reduce the need for red blood cell transfusions and prevent biliary leaks. Their widespread use, however, contrasts with the scarcity of data from controlled studies to support their clinical effectiveness. Therefore, a prospective, randomized, controlled, single-center study was performed in 300 patients who underwent elective hepatectomy, with and without application of fibrin seal on the raw liver surface. None of the variables evaluated (blood loss, transfusions, biliary fistulas and postoperative results) differed between the two groups. We conclude that the application of fibrin seal does not seem justified and that discontinuing its routine use would substantially reduce costs. The use of a new agent, Tachosil", is supported by a single multicenter, prospective, randomized, controlled trial&

Keywords:
Topical hemostatic agents
Surgery
Hemostasis
Coagulation
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