Gelfoam Sponge (Absorbable Gelatin Sponge, USP): Uses, Dosage, Side Effects, Interactions, Warning (2024)

Drug Description

h3>DESCRIPTION

GELFOAM Sterile Sponge is a medical device intended forapplication to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white,nonelastic, porous, pliable product prepared from purified pork Skin GelatinUSP Granules and Water for Injection, USP. It may be cut without fraying and isable to absorb and hold within its interstices, many times its weight of bloodand other fluids.

Indications

INDICATIONS

Directions For Use

Sterile technique should always be used to remove GELFOAMSterile 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 compressedbefore application to the bleeding site, and then held in place with moderate pressureuntil hemostasis results. When used with sterile saline, GELFOAM should befirst immersed in the solution and then withdrawn, squeezed between glovedfingers to expel air bubbles, and then replaced in saline until needed. The GELFOAMsponge 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 airis expelled and it does expand to its original size and shape when returned tothe sterile saline.

GELFOAM is used wet or blotted to dampness on gauzebefore application to the bleeding site. It should be held in place withmoderate pressure, using a pledget of cotton or small gauze sponge untilhemostasis results. Removal of the pledget or gauze is made easier by wettingit with a few drops of sterile saline, to prevent pulling up the GELFOAM whichby then should enclose a firm clot. Use of suction applied over the pledget ofcotton or gauze to draw blood into the GELFOAM is unnecessary, as the GELFOAMwill draw up sufficient blood by capillary action. The first application ofGELFOAM will usually control bleeding, but if not, additional applications maybe made using fresh pieces, prepared as described above.

Use only the minimum amount of GELFOAM, cut toappropriate size, necessary to produce hemostasis. The GELFOAM may be left inplace at the bleeding site, when necessary. Since GELFOAM causes little morecellular 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.For use with thrombin, consult the thrombin insert for complete prescribinginformation and proper sample preparation.

Dosage

DOSAGE AND ADMINISTRATION

Sterile technique should always be used in removing theinner envelope containing the GELFOAM Sterile Sponge from the outer printedsealed envelope. The minimum amount of GELFOAM of appropriate size and shapeshould be applied dry or wet (see INDICATIONS AND USAGE, Directionsfor Use) to the bleeding site and held firmly in place until hemostasis isobserved. Opened envelopes of unused GELFOAM should always be discarded.

HOW SUPPLIED

GELFOAM Sterile Sponge is supplied in a sterile envelopeenclosed in an outer peelable envelope. Sterility of the product is assuredunless the outer envelope has been damaged or opened. It is available in thefollowing sizes:

Storage And Handling

GELFOAM Sterile Sponge should be stored at 25°C (77°F);excursions permitted to 15-30°C (59-86°F) [see USP Controlled RoomTemperature]. Once the package is opened, contents are subject tocontamination. It is recommended that GELFOAM be used as soon as the package isopened and unused contents discarded.

This product is prepackaged sterile and intended only forsingle use. Reuse can result in transmission of bloodborne pathogens (including HIV and hepatitis), potentially endangering patients and health care providers.Adherence to the principles of aseptic technique when using this product is essential.

Caution

Federal law restricts this device to sale by or on theorder of a physician.

Manufactured by: Pharmacia and Upjohn Company, 7000Portage Road, Kalamazoo, Michigan 49001, USA, 1-800-253-8600, LAB-0309-4.0. RevisedDecember 2014. Distributed by: Pharmacia & Upjohn Co., Division of PfizerInc., New York, NY 10017. Revised: Dec 2014

Side Effects & Drug Interactions

SIDE EFFECTS

There have been reports of fever associated with the useof GELFOAM, without demonstrable infection. GELFOAM Sterile Sponge may serve asa nidus of infection and abscess formation¹, and has been reportedto potentiate bacterial growth. Giantcell granuloma has been reported at the implantation site of absorbable gelatin product in the brain,² ashas compression of the brain and spinal cord resulting from the accumulation ofsterile fluid.³

Foreign body reactions, encapsulation of fluid and hematoma have also been reported.

When GELFOAM was used in laminectomy operations, multipleneurologic 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 tendonrepair.

Toxic shock syndrome has been reported in associationwith the use of GELFOAM in nasal surgery.

Fever, failure of absorption, and hearing loss have beenreported in association with the use of GELFOAM during tympanoplasty.

Adverse Reactions Reported From Unapproved Uses

GELFOAM is not recommended for use other than as anadjunct for hemostasis.

While some adverse medical events following theunapproved use of GELFOAM have been reported to Pharmacia & Upjohn Company(see ADVERSE REACTIONS above), other hazards associated with such use may nothave been reported.

When GELFOAM has been used during intravascular catheterizationfor the purpose of producing vessel occlusion, the following adverse eventshave been reported; fever, duodenal and pancreatic infarct, embolization oflower extremity vessels, pulmonary embolization, splenic abscess, necrosis ofspecific anatomic areas, asterixis, and death.

The following adverse medical events have been associatedwith the use of GELFOAM for repair of dural defects encountered duringlaminectomy and craniotomy operations: fever, infection, leg paresthesias, neckand back pain, bladder and bowel incontinence, cauda equine syndrome, neurogenic bladder, impotence, and paresis.

DRUG INTERACTIONS

No information provided.

REFERENCES

1. Lindstrom PA: Complications from the use of absorbablehemostatic sponges. AMA Arch Surg. 1956; 73(1):133-141.

2. Knowlson GTG. Gelfoam granuloma in the brain. J NeurolNeurosurg Psychiatry 1974; 37:971-973.

3. Herndon JH, Grillo HC, Riseborough EJ, et al: Compression of the brain and spinal cord following use of GELFOAM. Arch Surg. 1972;104:107.

Warnings

WARNINGS

GELFOAM Sterile Sponge is not intended as a substitutefor meticulous surgical technique and the proper application of ligatures, orother conventional procedures for hemostasis.

GELFOAM is supplied as a sterile product and cannot beresterilized. Unused, opened envelopes of GELFOAM should be discarded. WARNING:To prevent contamination, employ aseptic procedure in opening envelope andwithdrawing GELFOAM. If the envelope is torn or punctured, the containedGELFOAM should not be used.

Only the minimum amount of GELFOAM necessary to achievehemostasis should be used. Once hemostasis is attained, excess GELFOAM shouldbe carefully removed.

The use of GELFOAM is not recommended in the presence ofinfection. GELFOAM should be used with caution in contaminated areas of thebody. If signs of infection or abscess develop where GELFOAM has beenpositioned, reoperation may be necessary in order to remove the infectedmaterial and allow drainage.

Although the safety and efficacy of the combined use ofGELFOAM with other agents such as topical thrombin has not been evaluated incontrolled clinical trials, if in the physician's judgment concurrent use ofother agents is medically advisable, the product literature for that agentshould be consulted for complete prescribing information.

While packing a cavity for hemostasis is sometimessurgically indicated, GELFOAM should not be used in this manner unless excessproduct 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 to its original size on absorbing fluids, andproduce nerve damage by pressure within confined bony spaces.

The packing or wadding of GELFOAM, particularly withinbony cavities, should be avoided, since swelling to original size may interferewith normal function and/or possibly result in compression necrosis ofsurrounding tissues.

Precautions

PRECAUTIONS

Use only the minimum amount of GELFOAM Sterile Spongeneeded for hemostasis, holding it at the site until bleeding stops and thenremoving the excess.

GELFOAM should not be used for controlling postpartum hemorrhage or menorrhagia.

It has been demonstrated that fragments of anotherhemostatic agent, microfibrillar collagen, pass through the 40μ 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 incontrolled clinical trials.

Microfibrillar collagen has been reported to reduce thestrength of methyl-methacrylate adhesives used to attach prosthetic devices tobone surfaces. As a precaution, GELFOAM should not be used in conjunction withsuch 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.

Positioning of the patient resulting in negativeperipheral venous pressure during a procedure has been reported to be acontributing factor resulting in life-threatening thromboembolic events.

Overdose & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

GELFOAM Sterile Sponge should not be used in closure ofskin incisions because it may interfere with healing of the skin edges. This isdue to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.

GELFOAM should not be placed in intravascularcompartments, because of the risk of embolization.

Do not use GELFOAM Sterile Sponge in patients with knownallergies to porcine collagen.

CLINICAL PHARMACOLOGY

Action

GELFOAM Sterile Sponge has hemostatic properties. Whileits mode of action is not fully understood, its effect appears to be morephysical than the result of altering the blood clotting mechanism.

When not used in excessive amounts, GELFOAM is absorbedcompletely, with little tissue reaction. This absorption is dependent uponseveral factors, including the amount used, degree of saturation with blood orother fluids, and the site of use.

When placed in soft tissues, GELFOAM is usually absorbedcompletely within four to six weeks, without inducing excessive scar tissue.When applied to bleeding nasal, rectal, or vagin*l mucosa, it liquefies withintwo to five days.

HEMOSTASIS: GELFOAM Sterile Sponge, used dry or saturatedwith sterile sodium chloride solution, is indicated in surgical procedures as ahemostatic device, when control of capillary, venous, and arteriolar bleedingby pressure, ligature, and other conventional procedures is either ineffectiveor impractical. Although not necessary, GELFOAM can be used either with orwithout thrombin to obtain hemostasis.

Clinical Studies

GELFOAM Sterile Sponge is a water-insoluble, hemostaticdevice prepared from purified skin gelatin, and capable of absorbing up to 45times its weight of whole blood.¹⁰ The absorptive capacity ofGELFOAM is a function of its physical size, increasing as the size of thegelatin sponge increases.¹¹

The mechanism of action of surface-mediated hemostaticdevices is supportive and mechanical.¹¹ Surface-acting devices, whenapplied directly to bleeding surfaces, arrest bleeding by the formation of anartificial clot and by producing a mechanical matrix that facilitates clotting.⁴Jenkins et-al 8 have theorized that the clotting effect of GELFOAM may be dueto release of thromboplastin from platelets, occurring when platelets enteringthe sponge become damaged by contact with the walls of its myriad interstices.Thromboplastin interacts with prothrombin and calcium to produce thrombin, andthis sequence of events initiates the clotting reaction. The authors suggestthat the physiologic formation of thrombin in the sponge is sufficient toproduce formation of a clot, by its action on the fibrinogen in blood.⁸The spongy physical properties of the gelatin sponge hasten clot formation and providestructural support for the forming clot.^4,5 Several investigatorshave claimed that GELFOAM becomes liquefied within a week or less and iscompletely absorbed in four to six weeks, without inducing excessive scarformation.^{7,10,12,13,14} Barnes¹³ reviewed experienceswith GELFOAM in gynecologic surgery. No excessive scar tissue, attributable tothe absorption of GELFOAM, could be palpated at postoperative examination.

Animal Pharmacology

Surface-acting hemostatic devices, when applied directlyto bleeding surfaces, arrest bleeding by providing a mechanical matrix thatfacilitates clotting.^4,5,6,7 Due to their bulk, surfaceacting hemostaticagents slow the flow of blood, protect the forming clot, and offer a frameworkfor deposition of the cellular elements of blood.^4,5,6,8 MacDonaldand Mathews⁹ studied GELFOAM implants in canine kidneys and reportedthat it assisted in healing, with no marked inflammatory or foreign-bodyreactions.

Jenkins and Janda⁵ studied the use of GELFOAMin canine liver resections and noted that the gelatin sponge appeared to offera protective cover and provide structural support for the reparative process.

Correll et al⁷ studied the histology ofGELFOAM Sterile Sponge when implanted in rat muscle and reported no significanttissue reaction.

REFERENCES

4. Guralnick W, Berg L: GELFOAM in oral surgery. OralSurg 1948; 1:629-632.

5. Jenkins HP, Janda R, Clarke J: Clinical and experimental observations on the use of gelatin sponge or foam. Surg 1946;20:124-132.

6. Jenkins HP, Janda R: Studies on the use of gelatin sponge or foam as a hemostatic agent in experimental liver resections andinjuries to large veins. Ann Surg. 1946;124:952-961.

7. Correll JT, Prentice HR, Wise EC: Biologic investigations of a new absorbable sponge. Surg Gynecol Obstet. 1945;181:585-589.

8. Jenkins HP, Senz EH, Owen H, et al: Present status ofgelatin sponge for control of hemorrhage. JAMA 1946; 132:614-619.

9. MacDonald SA, Mathews WH: Fibrin foam and GELFOAM inexperimental kidney wounds. Annual American Urological Association, July 1946.

10. Council on Pharmacy and Chemistry: Absorbable Gelatinsponge - new and nonofficial remedies. JAMA. 1947; 135:921.

11. Goodman LS, Gilman A: Surface-acting drugs, in The Pharmacologic Basis of Therapeutics, ed 6. New York, MacMillan Publishing Co. 1980,p 955.

12. Treves N: Prophylaxis of postmammectomy lymphedema bythe use of GELFOAM laminated rolls. Cancer 1952; 5:73-83.

13. Barnes AC: The use of gelatin foam sponges in obstetrics and gynecology. Am J Obstet Gynecol 1963; 86:105-107.

14. Rarig HR: Successful use of gelatin foam sponge in surgical restoration of fertility. Am J Obstet Gynecol. 1963; 86:136.

Medication Guide

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.