SURGISPON *
(ABSORBABLE GELATIN SPONGE)
DESCRIPTION
SURGISPON that is non-toxic, non-allergenic, non-immunogenic, non-pyrogenic and overall biocompatible. SURGISPON is a surgical haemostatic sponge, manufactured from highly purified first extract grade gelatin material for use in various surgical procedures, where traditional haemostatic is difficult or impractical and use of other non-absorbable materials is undesirable. SURGISPON absorbs approximately 40-50 times, its weight of water/blood and adheres easily to the bleeding site. The uniform porosity of SURGISPON guarantees a favorable haemostatic. When implanted in vivo, it is completely absorbed within 3-4 weeks.
SURGISPON gelatin sponges have a porous structure which activates the thrombocytes at the moment blood comes in contact with the matrix of the sponge. This causes the thrombocytes to release a series of substances which promote their aggregation at the same time as their surfaces change character, thus enabling them to act as a catalyst for the formation of the fibrin.
INDICATIONS
SURGISPON can be effectively used in various surgeries like:
Dental Surgery: SURGISPON may be used in oral surgery, dry or saturated with thrombin solution to control bleeding in extractions and apicenctomics especially in patients with a tendency to bleed extensively.
Malignancy: SURGISPON moistened with physiological salt solution or thrombin solution stops bleeding from tumor beds after section or from tumor beds after enucleation.
Abdominal Surgery: SURGISPON may be used dry, saturated with physiological salt solution or with thrombin solution. It is highly effective in stopping bleeding of the denuded visceral surfaces especially of the gall bladder, liver and spleen.
Orthopedic Surgery: SURGISPON moistened with physiological salt solution or thrombin solution, can be used to control bleeding from bone tissue. It does not interfere with healing process and is readily absorbed.
Neuro Surgery: SURGISPON moistened with thrombin solution is effective in repairing torn Dural venous sinuses to which ligatures can not or should not be applied, in stopping oozing from the dura under edges of the bone flap, in controlling bleeding in herniated disc operations, in osseous bleeding and epidural bleeding in laminectomy.
Genito- Urinary Surgery: SURGISPON embedded nephrotomy incisions control the bleeding without interfering with the healing process. Urinary wetting will not prevent absorption of the gelatin sponge. It will control hemorrhage following suprapublic prostatectomy and retrobubic prostatectomy.
Anorectal Surgery: SURGISPON is effective and well tolerated as a haemostatic dressing for the control of anal bleeding during plastic repair of an imperforate anus, and following hemorrhoidectomy and fistula operations.
Gynecological Surgery: SURGISPON of inestimable value in controlling bleeding during veginal plastic operations, extensive pelvic dissections, cervical amputation and biopsy and secondary bleeding after abdominal hysterectomy. It is not to be used menorrehagia or to control post-partum bleeding.
Otolaryngological Surgery: SURGISPON saturated with physiological salt solution eliminates post operative bleeding in sub mucous resections. Strip of SURGISPON placed in the nose and held for a few seconds will prevent bleeding following removal of nasal polyps. The same procedure can be utilized to control bleeding following sinus operations, adenoidectomy and tonsillectomy. The gel packing will disappear in approx. five days.
DIRECTIONS OF USE:
Sterile technique should always be used to remove SURGISPON Sterile Sponge from its packaging. Cut to the desired size, a piece of SURGISPON, 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 SURGISPON should be manually applied to the bleeding site, and held in place with moderate pressure until hemostasis results. When used with sterile saline, SURGISPON should be first immersed in the solution and then withdrawn, squeezed between gloved fingers to expel air bubbles, and then replaced in saline until needed. The SURGISPON sponge should promptly return to its original size, with slight expansion in thickness and shape in the solution. If it does not, it should be removed again and kneaded vigorously until all air is expelled and it does expand to its original size, with slight increases in thickness and shape when returned to the sterile saline.
SURGISPON if used wet it may be blotted to dampness on gauze before application to the bleeding site. It should be held in place with moderate pressure, using a pledget of cotton or small gauze sponge until hemostasis results. Removal of the pledget or gauze is made easier by wetting it with a few drops of sterile saline, to prevent pulling up the SURGISPON which by then should enclose a firm clot. Use of suction applied over the pledget of cotton or gauze to draw blood into the SURGISPON is unnecessary, as SURGISPON will draw up sufficient blood by capillary action. The first application of SURGISPON will usually control bleeding, but if not, additional applications may be made. For additional applications, fresh pieces should be used, prepared as described above.Use only the minimum amount of SURGISPON, cut to appropriate size, necessary to produce hemostasis. The SURGISPON may be left in place at the bleeding site, when necessary. Since SURGISPON causes little more cellular reaction than does the blood clot, the wound may be closed over it. SURGISPON may be left in place when applied to mucosal surfaces until it liquefies.
HANDLING AND STORAGE
SURGISPON Sterile sponge is packed in double sterile envelopes with guaranteed absolute sterility. It can be stored at cool dry place at room temperature. Once the package is opened, contents are subject to contamination. It is recommended that SURGISPON be used as soon as the package is opened and unused contents discarded.
PACKING
STANDARD PACK 80mmx50mmx10mm in box of 2 pieces and 10 pieces for General Surgery
NASAL PACK Box of four sponges each of 80mmx15mmx7mm approx.
GYNAECOLOGICAL PACK Box of four sponges each of 80mmx25mmx7mm approx.
DENTAL PACK Box of 10 sponges each of 20mmx20mmx7mm approx.
Manufactured in India AEGIS LIFESCIENCES
and Marketed by:APEX INDUSTRIES,182/78,INDUSTRIAL AREA,PHASE-I
CHANDIGARH 160 002
