[Topical hemostatic devices in surgery: between science and marketing].
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, which is limited by the small number of patients and by the fact that the variable analyzed--time from application to hemostasis--may not be clinically relevant.
González
Héctor Daniel
HD
Unidad de Cirugía Hepato-bilio-pancreática, Servicio de Cirugía General y Digestiva, Hospital de Girona Dr. Josep Trueta, IdiBGi, Girona, España.
Figueras Felip
Joan
J
D035843:Biomedical Research; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D006488:Hemostasis, Surgical / Q000379:methods*; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D040541:Marketing; D011446:Prospective Studies
D015718:Fibrin Tissue Adhesive; D006490:Hemostatics