Haemostatic gelatin film sponge, resorbable, 200x70x0.5mm, 10 pieces

The hemostatic sponge SCROFALON absorbs approximately 40-50 times, is not soluble in water and easily adheres to the bleeding site. The uniform porosity guarantees a favorable hemostasis. When it is implanted, complete absorption takes place in 3-4 weeks. The SCROFALON hemostatic sponge is sterile, resorbable, non-toxic, non-allergenic, non-immunogenic, non-pyrogenic and meets the biocompatibility requirements according to the applicable EN ISO 10993 standards. Gelatin is a substantially pure protein food ingredient, obtained by the thermal denaturation of collagen, which are the structural mainstay and most common protein in the animal kingdom. Gelatin sponges have been used in clinical practice as hemostats for more than 50 years and been probe to be effective and safe as other types of hemostats. SCROFALON is white, pliable, light and insoluble in water. It is removed from the package under strict aseptic conditions and can be cut to desired size, applied dry or saturated with physiological salt solution or thrombin or an antibiotic solute on of desired concentration. Squeeze the material between two fingers to remove the air bubbles so that the sponge, while immersed in the solution will regain its original size and shape almost immediately. At the time of use, the superfluous solution may be allowed to drip upon a gauze compress. The saturated sponge is then applied to the hemorrhage area and is then held in place with moderate pressure for 10-15 seconds. Usually the first application of SCROFALON will control bleeding, but if not, additional application should be made using fresh pieces of sponge. When bleeding is controlled, the pieces of SCROFALON should be left in place; otherwise bleeding may start again. Since SCROFALON causes little more cellular infiltration than the blood clot the wound may be closed over it. The size of the sponge is 200 x 70 x 0.5mm. The set contains 10 pieces. Precautions & Warnings - Use of SCROFALON is not recommended for infected sites - By absorbing the fluid, the sponge may expand and thus impinge on neighboring structures. Hence minimal precompression is advised when packing into cavities. - While using SCROFALON other normal haemostatic procedures including suture, pressure and ligature should not be neglected - Sterility is not guaranteed if the pack is damaged or tampered. - Keep out of reach of children - Re-use of the left out product after usage with and without sterilization is strictly not recommended due to the underlying risk factors. 1. Cross contamination and hospital acquired infection of the device when the unused portion of the device is stored for reuse. 2. Sterility of the product is not guaranteed when unused portion of device is left in the pack 3. Resterilization process such as heat or ETO would result in the change of characteristics of the product and there by failure of intended purpose of the product. SCROFALON Film: This is the thinnest dimension, ideal to be used in neurosurgery, vascular surgery and plastic surgery in which the sponge needs to have a protective effect in addition to acting as a hemostat. It also possess property of minimal expansion upon absorption of blood. In Neurosurgery, Film is applicable with advantage in procedures such as, to control bleeding from vault of cranium at craniotomy, to cover dural defects, in controlling epidural hemorrhage, in the spinal canal, in diffuse bleeding in a tumour bed, etc. In Vascular surgery, it may be used for addressing the 2 common problems, such as for controlling leakage in sutures vessel or an anastomic area and leakage of vessels from place which is difficultly accessible. In Plastic surgery, use of Film helps in quick controlling of diffuse bleeding from large areas, bleeding from donor sites etc.