GELFOAM Sterile Compressed Sponge could be a medical device supposed for application to haemorrhage surfaces as a styptic. it's a water-insoluble, off-white, nonelastic, porous, pliable product ready from sublimate porcine skin, Gelatin USP Granules and Water for Injection, USP. it should be cut while not fraying and is in a position to soak up and hold among its interstices, over and over its weight of blood and alternative fluids.
Generic Name: absorbable gelatin compressed sponge, usp
Gelfoam Compressed Sponge Indications:
HEMOSTASIS: GELFOAM Sterile Compressed Sponge, used dry or saturated with sterile binary compound answer, is indicated in surgical procedures as a astringent device, once management of capillary, venous, and artery haemorrhage by pressure, ligature, and alternative typical procedures is either ineffective or impractical. though not necessary, GELFOAM is used either with or while not coagulase to get hemostasia.
Directions to be used
Sterile technique must always be accustomed take away GELFOAM Sterile Compressed Sponge from its packaging. move the required size, a bit of GELFOAM, either dry or saturated with sterile, isotonic binary compound answer (sterile saline), is applied with pressure on to the haemorrhage web site.
When applied dry, one piece of GELFOAM ought to be manually applied to the haemorrhage web site, and command in situ with moderate pressure till hemostasia results.
When used with sterile saline, GELFOAM ought to be 1st immersed within the answer and so withdrawn, squeezed between gauntleted fingers to expel air bubbles, and so replaced in saline till required. The GELFOAM sponge ought to promptly come back to its original size, with slight growth in thickness and form within the answer. If it doesn't, it ought to be removed once more and kneaded smartly till all air is expelled and it will expand to its original size, with slight will increase in thickness and form once came to the sterile saline.
GELFOAM if used wet it should be blotted to moistness on gauze before application to the haemorrhage web site. It ought to be command in situ with moderate pressure, employing a pledget of cotton or little gauze sponge till hemostasia results. Removal of the pledget or gauze is formed easier by wetting it with some drops of sterile saline, to forestall pull up the GELFOAM, that by then ought to enclose a firm clot.
Use of suction applied over the pledget of cotton or gauze to draw blood into the GELFOAM is senseless, as GELFOAM can draw up sufficient blood by surface tension. the primary application of GELFOAM can typically management haemorrhage, but if not, extra applications is also created. for added applications, recent items ought to be used and ready as antecedently delineated .
Use solely the minimum quantity of GELFOAM, move applicable size, necessary to provide hemostasia. The GELFOAM is also left in situ at the haemorrhage web site, once necessary. Since GELFOAM causes very little a lot of cellular reaction than will the grume, the wound is also closed over it. GELFOAM is also left in situ once applied to membrane surfaces till it liquefies.
For use with coagulase, consult the coagulase insert for complete prescribing data and correct sample preparation.
Gelfoam Compressed Sponge Dosage:
Sterile technique should be employed in removing the inner envelope containing the GELFOAM Sterile Sponge from the outer written sealed envelope. The minimum quantity of GELFOAM of applicable size and form ought to be applied (dry or wet, see Directions for Use) to the harm website and control firmly in situ till haemostasia is discovered. Opened envelopes of unused GELFOAM should be discarded.
Gelfoam Compressed Sponge Side Effects:
There are reports of fever related to the utilization of GELFOAM, while not demonstrable infection. GELFOAM Sterile Compressed Sponge could kind a nidus of infection and symptom formation1, and has been rumored to heighten microorganism growth. Giant-cell tumor has been rumored at the implantation website of absorbable gelatin product within the brain2, associate degreed compression of the brain and funiculus ensuing from an accumulation of sterile fluid3 has been rumored following use of absorbable gelatin sponge in closed house.
Foreign body reactions, “encapsulation” of fluid and haematoma have additionally been rumored. once GELFOAM was employed in ablation operations, multiple medicine events were rumored, together with however not restricted to body structure equina syndrome, spinal stricture, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and intestine pathology, and impotence.
Excessive pathology and prolonged fixation of a sinew are rumored once absorbable gelatin merchandise were employed in cut tendon repair.
Toxic shock syndrome has been rumored in association with the utilization of GELFOAM in nasal surgery.
Fever, failure of absorption, and deafness are rumored in association with the utilization of GELFOAM throughout surgical procedure.
Adverse Reactions rumored From Unapproved Use
GELFOAM isn't counseled to be used aside from as an adjunct for hemostasia. whereas some adverse medical events following the unapproved use of GELFOAM are rumored, alternative hazards related to such use might not are rumored.
When GELFOAM has been used throughout intravascular catheterization for the aim of manufacturing vessel occlusion, the subsequent adverse events are reported; fever, small intestine and duct gland pathology, embolization of lower extremity vessels, respiratory organ embolization, lienal symptom, gangrene of specific anatomic areas, asterixis, and death. These adverse medical events are related to the utilization of GELFOAM for repair of meninx defects encountered throughout ablation and surgical operation operations: fever, infection, leg paresthesias, neck and back pain, bladder and intestine incontinence, body structure equina syndrome, bladder disorder, impotence, and palsy.