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Instructions for use:
This attachment is not a surgical technique guide. It is designed to help you use the product.
PRODUCT DESCRIPTION SURGISPON ® - Hemostatic surgical sterile gelatin absorbent sponge; pyrogenic, biocompatible, plastic, insoluble in water. It is used for hemostatic purposes by contact with the bleeding surface.
SURGISPON ® - manufactured from highly purified gelatin material of the first class for use in many surgical procedures. When implanting the necessary amount in-vivo , the sponge is completely resorbed after 3-4 weeks. When applied to bleeding mucous surfaces, it thins out after 2-5 days.
SURGISPON ® gelatin sponge has a porous structure that activates platelets at the moment of blood contact with the sponge matrix. It stimulates platelets to release a series of substances that cause their aggregation. At the same time, SURGISPON ® modifies the nature of the surface of platelets, so that they begin to act as catalysts for the formation of fibrin.
Packaging: SURGISPON ® is available in different shapes and sizes suitable for different surgical procedures.
Indications: SURGISPON ® is effectively used in various operations for hemostasis, when control of capillary, venous and arterial bleeding by compression, ligature or other standard methods is ineffective or impossible.
Contraindications: SURGISPON ® should not be used:
• with skin cuts, as it can prevent the healing of the wound edges;
• in patients with allergic reactions to collagen;
• intravascularly, as this may cause the risk of embolism;
• in combination with methyl methacrylate adhesives;
• in combination with autologous blood transfusion;
• as primary therapy for the treatment of coagulation disorders;
• with purulent wounds;
• to control postpartum bleeding and menorrhagia;
• with pulsating arterial bleeding;
• when blood mixes with other fluids, or in cases where the bleeding site is submerged.
SURGISPON ® sponge will not act as a tampon or plug to stop bleeding.
Safety and efficacy of SURGISPON ® have not been established:
• during ophthalmological procedures
• in children and pregnant women.
The safety and efficacy of use in urological procedures have not been established in randomized clinical trials. During urological procedures, gelatin sponges should not remain in the renal calyces and pelvis, bladder, urethra or ureters, to eliminate potential foci of stone formation. SURGISPON ® , as a hemostatic agent, should not be used in neurosurgery close to viable brain tissue, as it may cause a giant cell granulomatous reaction. Also, the safety and effectiveness of the combined use of gelatin sponge with other agents, such as topical thrombin, antibiotics in solutions or in powders, have not been studied in controlled clinical trials. The advisability of simultaneous use of SURGISPON ® with topical thrombin or other means is decided by the doctor based on data from the literature on the use of the products.
Instructions for use / Warnings / Warnings:
SURGISPON ® can be used dry or soaked in saline. A cut piece of SURGISPON ® of the required size, dry or soaked in a sterile physiological solution of sodium chloride, is easily pressed directly to the bleeding site.
When using a dry piece of SURGISPON ® , it is manually pressed to the bleeding site and held with moderate pressure until the hemostatic effect is achieved.
When used with sterile saline, SURGISPON ® must first be immersed in the solution, then removed, squeezed with gloved fingers to remove air bubbles, then re-immersed in the solution as long as necessary. The SURGISPON ® sponge should quickly return to its original size, with little expansion in thickness and shape in solution. If this does not happen, all air must be removed again until it returns to its original size, with a slight increase in thickness and shape when returned to sterile saline.
If SURGISPON ® is used wet, it may be attached to gauze prior to application to the bleeding site. It is necessary to hold it in place with moderate pressure, using a cotton or gauze tampon, until the hemostatic effect occurs.
It is better to moisten the tampon or gauze with a few drops of sterile physiological solution to prevent the extraction of SURGISPON ® , which by that time should be attached by a dense clot.
Additionally, it is not necessary to perform suction over a gauze or cotton swab to inject blood into SURGISPON ® , as SURGISPON ® will receive enough blood through the interaction with the capillaries.
Since SURGISPON ® causes a much greater cellular reaction than a thrombus, the wound can be completely closed by it. SURGISPON ® can remain on the mucosal surface until complete dissolution.
SURGISPON ® is not a substitute for surgical techniques and proper application of ligatures or other standard procedures for hemostasis.
SURGISPON ® should not be used as primary therapy for coagulation disorders.
SURGISPON ® specificity for use on contaminated areas of the body: if there are signs of purulent infection or abscess development in the area of SURGISPON ® application, repeated surgery may be required to remove infected areas and ensure drainage.
Patient-specific factors must be considered for in vivo treatment. Infected or contaminated wounds should undergo appropriate surgical treatment.
Users should familiarize themselves with the surgical procedures and technique of using the gelatin sponge before using it.
STERILITY: SURGISPON ® is a sterile sponge packed in a sterile blister with a guarantee of sterility. It is recommended to use SURGISPON ® as soon as possible after opening the package, and to destroy unused residues. The product can be used once. There should be no re-use or re-sterilization, as physical characteristics may be compromised along with sterility.
Open the blister pack by spreading its two ends so that SURGISPON ® falls intact onto the site of bleeding or onto a sterile surface.
SURGISPON ® is sterilized by gamma radiation. ! Do not use if package is open or damaged. After opening the package, the contents may be contaminated. This product has been designed, tested and manufactured for single patient use only. Reuse, use of the product from an open or damaged package, may harm the patient.
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The product should be stored in the original packaging in a clean, dry room at a temperature of 5 ° C to 30 ° C. protect from direct sunlight and heat.
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