Gelfoam174; Pfizer（明胶海绵174;辉瑞）.pdf

GGelfoam® absorbable gelatin compressed sponge, USP DESCRIPTION GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine skin, Gelatin USP Granules and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. ACTIONS GELFOAM Sterile Compressed Sponge has hemostatic properties. While its mode of action is not fully understood, its effect appears to be more physical than the result of altering the blood clotting mechanism. When not used in excessive amounts, GELFOAM is absorbed completely, with little tissue reaction. This absorption is dependent on several factors, including the amount used, degree of saturation with blood or other fluids, and the site of use. When placed in soft tissues, GELFOAM is usually absorbed completely within four to six weeks, without inducing excessive scar tissue. When applied to bleeding nasal, rectal, or vaginal mucosa, it liquefies within two to five days. CLINICAL STUDIES GELFOAM Sterile Compressed Sponge is a water-insoluble, hemostatic device prepared from purified porcine skin gelatin, and capable of absorbing up to 45 times its weight of 4 whole blood. The absorptive capacity of GELFOAM is a function of its physical size, increasing as the size of the gelatin sponge increases.5 The mechanism of action of surface-mediated hemostatic devices is supportive and mechanical.5 Surface-acting devices, when applied directly to bleeding surfaces, arrest bleeding by the formation of an artificial clot and by producing a mechanical matrix that facilitates clotting.6 7 Jenkins et al have theorized that the clotting effect of GELFOAM may be due to release of thromboplastin from platelets, oc