Ethicon Surgifoam Absorbable Gelatin Sponge

How to use Surgifoam Gelatin Sponge?

• Before using, inspect the package for signs of damage. If the package is damaged or wet, sterility cannot be assured and the contents should not be used.
• Sterile technique should always be used to remove the Surgifoam Absorbable Gelatin Sponge from its packaging.
• Cut the sponge to the desired size. Use only the minimum amount necessary to achieve hemostasis.
• This piece of Surgifoam Sponge can be applied to the bleeding site either dry or saturated with sterile isotonic sodium chloride solution (sterile saline) or sterile topical thrombin solution.
• Each sponge is individually sealed in a sterile package. If the individual package is opened or the seal has been breached, the unused sponge should be discarded, since they are not intended for reuse and/or resterilization
• Cut the sponge to desired size and shape.
• Manually compress the Ethicon Surgifoam Sponge prior to applying to the bleeding site.
• Hold the sponge in place with moderate pressure until hemostasis is achieved.
• Removal of excess sponge upon achieving hemostasis can be accomplished by gentle irrigation of the site with a sterile saline solution to completely wet the sponge.
• Use only the amount required to achieve hemostasis and remove any excess.
• Use With Sterile Saline or Thrombin Preparation
  
  • Cut the Surgifoam Absorbable Gelatin Sponge to desired size and shape.
  • Immerse the sponge in the solution.
  • Withdraw sponge and squeeze between gloved fingers to expel air bubbles.
  • Return sponge to the solution until needed. The Surgifoam Sponge should promptly return to its original size and shape in the solution. If it does not, remove the sponge from the solution and vigorously knead it between gloved fingers until all air is expelled and it can return to its original size and shape when placed in the solution.
  • Blot sponge to desired dampness on gauze before applying to the bleeding site.
  • Hold the Surgifoam Absorbable Gelatin Sponge in place with gauze using moderate pressure until hemostasis is achieved.
  • Removal of gauze is aided by wetting with a few drops of saline, which helps prevent removal of the Surgifoam Sponge and clot.
  • Removal of excess sponge upon achieving hemostasis can be accomplished by gentle irrigation of the site with a sterile saline solution to completely wet the sponge.
  • Use only the amount required to achieve hemostasis and remove any excess.

• Do not use Surgifoam Absorbable Gelatin Sponge in the closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.
• Do not use it in intravascular compartments because of the risk of embolization.
• Do not use it on patients with known allergies to porcine collagen.
• Ethicon Surgifoam Sponge is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
• It should not be used in the presence of infection.
• It should be used with caution in contaminated areas of the body. If signs of infection or abscess develop where the sponge has been positioned, reoperation may be necessary in order to remove the infected material and allow drainage.
• It should not be used in instances of pumping arterial hemorrhage. It should not be used where blood or other fluids have pooled or in cases where the point of hemorrhage is submerged.
• It will not act as a tampon or plug in a bleeding site, nor will it close off an area of blood collecting behind a tampon.
• It should be removed if possible once hemostasis has been achieved because of the possibility of dislodgment of the device or compression of other nearby anatomic structures.
• Surgifoam Sponge should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.
• Its safety and effectiveness for use in ophthalmic procedures have not been established.
• It should not be used for controlling post-partum bleeding or menorrhagia.
• Its safety and effectiveness have not been established in children and pregnant women.

Precautions to be taken while using Surgifoam Sponge:

• It is supplied as a sterile product and cannot be resterilized. If the individual package is opened or the seal has been breached, the unused sponge should be discarded.
• When placed into cavities or closed tissue spaces, minimal preliminary compression is advised and care should be exercised to avoid overpacking (the sponge expands upon absorption of liquid).The sponge may swell to its original size on absorbing fluids, creating the potential for nerve damage.
• While packing a cavity for hemostasis is sometimes surgically indicated, Surgifoam Sponge should not be used in this manner unless excess product not needed to maintain hemostasis is removed.
• Only the minimum amount of sponge needed to achieve hemostasis should be used. Once hemostasis is achieved, any excess sponge should be carefully removed.
• It should not be used in conjunction with autologous blood salvage circuits. It has been demonstrated that fragments of collagen-based hemostatic agents may pass through 40µ transfusion filters of blood scavenging systems.
• It should not be used in conjunction with methyl methacrylate adhesives. Microfibrillar collagen has been reported to reduce the strength of methyl methacrylate adhesives used to attach prosthetic devices to bone surfaces.
• It should not be used for the primary treatment of coagulation disorders.
• Although the safety and effectiveness of the combined use of Surgifoam Sponge with other agents such as topical thrombin, antibiotic solution or antibiotic powder have not been evaluated in controlled clinical trials, if in the physician’s judgment, concurrent use of topical thrombin or other agents is medically advisable, the product literature for that agent should be consulted for complete prescribing information.
• The safety and effectiveness for use in urological procedures have not been established through a randomized clinical study.
• In urological procedures, Surgifoam Absorbable Gelatin Sponge should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.
• Precautions should be taken to assure that none of the material is aspirated by the patient.

• Ethicon Surgifoam Sponge should be stored dry at controlled room temperature 15°-30° C (59°-86° F).
• It is recommended that the sponge is used as soon as the package is opened.

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