compressed sponge, USP
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.
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.
HEMOSTASIS: GELFOAM Sterile Compressed 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 Compressed
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 applied to the
bleeding site, and held in place with moderate pressure until hemostasis results.