| GELFOAM® |
|Pharmacia & Upjohn |
|Absorbable Gelatin |
|Description: Gelfoam 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 and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Gelfoam sterile powder is a fine, dry, heat-sterilized light powder prepared by milling absorbable gelatin sponge. Gelfoam sterile sponge may be cut without fraying. |
|Action And Clinical Pharmacology: Gelfoam 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 in from 4 to 6 weeks, without inducing excessive scar tissue. When applied to bleeding nasal, rectal or vaginal mucosa, it liquefies within 2 to 5 days.
Indications And Clinical Uses: Hemostasis: Gelfoam sterile sponge, used dry or saturated with sterile sodium chloride solution, and Gelfoam sterile powder, saturated with sterile sodium chloride solution are 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.
However, in case of brisk arterial bleeding, the pressure of the flow may prevent the sponge from remaining securely anchored, and bleeding is likely to continue.
Contra-Indications: Gelfoam should not be used in closure of skin incisions because it may interfere with healing of the skin edges. This is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.
Gelfoam should not be placed in intravascular compartments, because of the risk of embolization.
Manufacturers' Warnings In Clinical States: Gelfoam is not intended as a substitute for meticulous surgical technique and the proper application of ligatures, or other conventional procedures for hemostasis.
Gelfoam sterile sponge should not be resterilized by heat, because heating may change absorption time. Ethylene oxide is not recommended for resterilization because it may be trapped in the interstices of the foam. Although, not reported for Gelfoam, the gas is toxic to tissue, and in trace amounts may cause burns or irritation.
Gelfoam sterile powder is supplied as a sterile product and cannot be resterilized. Unused, opened jars of Gelfoam should be discarded.
Only the minimum amount of Gelfoam necessary to achieve hemostasis should be used. Once hemostasis is attained, excess Gelfoam should be carefully removed.
The use of Gelfoam is not recommended in the presence of infection. Gelfoam should be used with caution in contaminated areas of the body. If signs of infection or abscess develop where Gelfoam has been positioned, reoperation may be necessary in order to remove the infected material and allow drainage.
The safety and efficacy of the combined use of Gelfoam with other agents such as topical thrombin has not been evaluated in controlled clinical trials and therefore cannot be recommended. If in the physician's judgment concurrent use of topical thrombin or other agents are medically advisable, the product literature for that agent should be consulted for complete prescribing information.
While packing a cavity for hemostasis is sometimes surgically indicated, Gelfoam should not be used in this manner unless excess product not needed to maintain hemostasis is removed.
Whenever possible, it should be removed after use in laminectomy procedures and from foramina in bone, once hemostasis is achieved. This is because Gelfoam may swell on absorbing fluids, and produce nerve damage by pressure within confined bony spaces.
The packing of Gelfoam, particularly within bony cavities, should be avoided, since swelling may interfere with normal function and/or possibly result in compression necrosis of surrounding tissues.
Precautions: The minimum amount of Gelfoam needed for hemostasis should be applied together with pressure until the bleeding stops. The excess should then be removed.
Gelfoam should not be used for controlling postpartum hemorrhage or menorrhagia. It has been demonstrated that fragments of another hemostatic agent, microfibrillar collagen, pass through the 40 µ transfusion filters of blood scavenging systems. Gelfoam should not be used in conjunction with autologous blood salvage circuits since the safety of this use has not been evaluated in controlled clinical trials.
Microfibrillar collagen has been reported to reduce the strength of methylmethacrylate adhesives used to attach prosthetic devices to bone surfaces. As a precaution, Gelfoam should not be used to attach prosthetic devices to bone surfaces. As a precaution, Gelfoam should not be used in conjunction with such adhesives.
Gelfoam is not recommended for the primary treatment of coagulation disorders.
It is not recommended that Gelfoam be saturated with an antibiotic solution or dusted with antibiotic powder.
Because Gelfoam absorbs fluid, it may expand and impinge on neighboring structures. Therefore, when placed into cavities or closed tissue spaces, minimal preliminary compression is advised and care should be taken to avoid overpacking.
Adverse Reactions: There have been reports of fever associated with the use of Gelfoam, without demonstrable infection. Gelfoam may serve as a nidus for infection and abscess formation, and has been reported to potentiate bacterial growth. Giant-cell granuloma has been reported at the implantation site of absorbable gelatin product in the brain, as has compression of the brain and spinal cord resulting from the accumulation of sterile fluid.
Foreign body reactions, "encapsulation" of fluid and hematoma have also been reported.
When Gelfoam was used in laminectomy operations, multiple neurologic events were reported, including but not limited to cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and impotence.
Excessive fibrosis and prolonged fixation of a tendon have been reported when absorbable gelatin products were used in severed tendon repair.
Toxic shock syndrome has been reported in association with the use of Gelfoam in nasal surgery.
Fever, failure of absorption, and hearing loss have been reported in association with the use of Gelfoam during tympanoplasty.
Adverse Reactions Reported From Unapproved Uses: Gelfoam is not recommended for use other than as an adjunct for hemostasis.
While some adverse medical events following the unapproved use of Gelfoam have been reported to Pharmacia & Upjohn (see Adverse Effects), other hazards associated with such use may not have been reported.
When Gelfoam has been used during intravascular catheterization for the purpose of producing vessel occlusion, the following adverse events have been reported: fever, duodenal and pancreatic infarct, embolization of lower extremity vessels, pulmonary embolization, splenic abscess, necrosis of specific anatomic areas, asterixis and death.
These adverse medical events have been associated with the use of Gelfoam for repair of dural defects encountered during laminectomy and craniotomy operations: fever, infection, leg paresthesias, neck and back pain, bladder and bowel incontinence, cauda equina syndrome, neurogenic bladder, impotence, and paresis.
Dosage And Administration: Sterile technique should always be used. The minimum amount of Gelfoam should be applied to the bleeding site (see Directions For Use) with pressure until hemostasis is observed. Opened packages or jars of unused Gelfoam should always be discarded.
Directions for Use: Sponge: Always use sterile technique when handling Gelfoam sterile sponge.
Gelfoam should be cut to the minimum size required to attain hemostasis. Gelfoam may be applied dry or saturated with a physiologic saline solution.
When applied dry, Gelfoam should be manually compressed before application to the bleeding site. When used with saline, Gelfoam should be soaked in the solution, then withdrawn, squeezed between gloved fingers to expel air bubbles present in the interstices, replaced in saline, and kept there until needed. Gelfoam should immediately return to its original size and shape when returned to the solution. If it does not swell, it should be removed and kneaded vigorously until all air is expelled and it does expand to its original shape when dropped into the solution. Gelfoam can be used wet or blotted to dampness on gauze before application to the bleeding site.
Gelfoam should be applied to the bleeding surface and held in place with moderate pressure until hemostasis is attained. It is not necessary to apply suction to Gelfoam, since Gelfoam will draw up blood into its interstices by capillary action.
Usually, the first application of Gelfoam will control bleeding, but if not, additional applications may be made, using fresh pieces of Gelfoam.
Directions for Use: Powder: Gelfoam sterile powder can be saturated with sterile, isotonic sodium chloride solution (sterile saline), before use as an adjunct to hemostatis. The jar of Gelfoam sterile powder should be opened and the contents (1 g) poured carefully into a sterile beaker, avoiding contamination. Using sterile technique, a putty-like paste is prepared by adding a total of approximately 3 to 4 mL of sterile saline to the Gelfoam. Dispersion of the powder can be avoided by initially compressing it with the gloved fingers into the bottom of the beaker and then kneading it into the desired consistency. The resulting doughy paste may be smeared or pressed against the bleeding surface to control bleeding. When bleeding stops the excess should be removed.
Use only the minimum amount of Gelfoam, necessary to produce hemostasis. The Gelfoam may be left in place at the bleeding site, when necessary. Since Gelfoam causes little more cellular reaction than does the blood clot, the wound may be closed over it. Gelfoam may be left in place when applied to mucosal surfaces until it liquefies.
Availability And Storage: Powder: Each jar contains: absorbable gelatin powder 1 g.
Sponge: Size 12.7 mm: 20 mm“60 mm (12 cm“7 mm, boxes of 4 sponges in individual envelopes.
Size 100: 80 mm“125 mm (100 cm“10 mm, boxes of 6 sponges in individual envelopes.
Size 2 cm: (approximately 40 cm“2 cm), individual envelopes.
Dental Pack Size 4: 20 mm“20 mm (4 cm“7 mm, jars of 15 sponges.
Store at controlled room temperature 15 to 30°C. Once the package or jar is opened, the contents are subject to contamination. It is recommended that Gelfoam be used as soon as the package or jar is opened and the unused contents discarded.