Pfizer 908-3300 - SPONGE, GELFOAM, SIZE 12, 12/BX
Gelfoam Absorbable Gelatin Sponge Topical Sponge
Gelfoam Dental Sponges are sterile, surgical sponges prepared from a specially treated and purified gelatin solution and are absorbable. In oral and dental surgery, Gelfoam Dental Sponges are an aid in providing hemostasis (cessation of bleeding). Gelfoam may be used either dry or moistened, depending upon conditions present at operation and preference of the surgeon. Isotonic saline is suitable for use with Gelfoam. Although not necessary, Gelfoam can be used either with or without thrombin to obtain hemostasis.
GELFOAM Sterile 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 pork 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.
Action
GELFOAM Sterile 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 upon 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. HEMOSTASIS: GELFOAM Sterile Sponge, used dry or saturated with sterile sodium chloride solution, is indicated in surgical procedures as a hemostatic device, when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
Directions for Use
Sterile technique should always be used to remove GELFOAM Sterile Sponge from its packaging. Cut to the desired size, a piece of GELFOAM, either dry or saturated with sterile, isotonic sodium chloride solution (sterile saline), can be applied with pressure directly to the bleeding site. When applied dry, a single piece of GELFOAM should be manually compressed before application to the bleeding site, and then held in place with moderate pressure until hemostasis results. When used with sterile saline, GELFOAM should be first immersed in the solution and then withdrawn, squeezed between gloved fingers to expel air bubbles, and then replaced in saline until needed. The GELFOAM sponge should promptly return to its original size and shape in the solution. If it does not, it should be removed again and kneaded vigorously until all air is expelled and it does expand to its original size and shape when returned to the sterile saline.
GELFOAM is used wet or blotted to dampness on gauze before application to the bleeding site. It should be held in place with moderate pressure, using a pledget of cotton or small gauze sponge until hemostasis results. Removal of the pledget or gauze is made easier by wetting it with a few drops of sterile saline, to prevent pulling up the GELFOAM which by then should enclose a firm clot. Use of suction applied over the pledget of cotton or gauze to draw blood into the GELFOAM is unnecessary, as the GELFOAM will draw up sufficient blood by capillary action. The first application of GELFOAM will usually control bleeding, but if not, additional applications may be made using fresh pieces, prepared as described above.
