What is SURGISPON®?
SURGISPON® – Absorbable Haemostatic Gelatin Sponge is a sterile malleable, water insoluble, gelatin absorbable sponge intended for haemostatic use. SURGISPON® is non-pyrogenic and biocompatible.
For additional Info: https://www.healthklin.com/surgispon-absorbable-gelatin-sponge-one-piece
What is SURGISPON® made of?
SURGISPON® Sponge is made from highly purified first grade gelatine material.
What does SURGISPON® look like?
SURGISPON® – is a white to pale yellow, sterile malleable, water insoluble, gelatin absorbable sponge intended for haemostatic use by applying to a bleeding surface. It is available in various sizes and shapes
What is SURGISPON® used for?
SURGISPON® can be effectively used in various surgeries for haemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.
How do you use SURGISPON®?
SURGISPON® may be used dry or saturated with physiological salt solution. 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 light pressure directly to the bleeding site.
Can SURGISPON® be cut into different dimensions?
Yes, SURGISPON® sponges can be cut into the desired dimension.
SURGISPON® sponges are already available in different dimensions as required in market and as per different surgical conditions. However, as per need surgeon can also further cut them into desired dimensions prior to usage.
What is the absorption capacity of SURGISPON®?
SURGISPON® Absorbs 40-50 times its own weight of water/oxalate blood
Can SURGISPON® be used wet? How?
When used with sterile saline, SURGISPON® should be first immersed in the solution and then withdrawn, squeezed between gloved fingers to expel air bubbles, and then replaced in saline until needed.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. It should be held in place with moderate pressure, using a pledget of cotton or small gauze sponge until haemostasis results.
Can SURGISPON® be used dry? How?
Yes, SURGISPON® can be used as dry. A single piece of SURGISPON® should be manually applied to the bleeding site, and held in place with moderate pressure until haemostasis results.
Is SURGISPON® absorbable?
Yes, when implanted in vivo and used inappropriate amounts, it is completely absorbed within <4 weeks.
How long do you leave SURGISPON® on?
Once haemostasis is achieved any excess Gelatin Sponge should be carefully removed because of the possibility of dislodgement of the device or compression of other nearby anatomic structures. It may be left in place when applied to mucosal surfaces until it liquefies.
Can SURGISPON® be used in on-site Emergency situation?
SURGISPON® can be effectively used in various surgeries for haemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.
Can SURGISPON® be used in patients with Coagulation Disorder?
It is not intended for primary treatment of coagulation disorders hence included in IFU under precautions.
Can SURGISPON® be left on wound?
Use only the minimum amount of SURGISPON® needed for haemostasis, holding it at the site until bleeding stops and then removing the excess. SURGISPON® may be left in place when applied to mucosal surfaces until it liquefies.
Can over packing / excessive amount of SURGISPON® be produced complications?
The over packing of SURGISPON®, should be avoided, since recovering to its initial volume may interfere with normal function and/or could cause possible or eventual compression necrosis of surrounding tissue and nerve damage
Is SURGISPON® used in dentistry?
SURGISPON® Dental cubes (absorbable gelatin dental sponge cubes) is a specified size for the uses in oral and dental surgery as an aid in providing hemostasis.
Is SURGISPON® applicable for controlling postpartum haemorrhage or menorrhagia?
It is not recommended for this application.
Can SURGISPON® be used conjunction with methyl methacrylate adhesives?
No. It should not be used in conjunction with methyl methacrylate adhesives.
Can SURGISPON® be used in conjunction with autologous blood salvage circuits?
No. It should not be used in conjunction with autologous blood salvage circuits.
Can SURGISPON® be used in infected areas / in presence of infection at the application site?
It is not recommended to use SURGISPON® product at those site where already infected / contaminated.
What other brands of Absorbable Gelatin Sponge are available in the International market?
Gelfoam from Pfizer, Spongostan from Ethicon
What is ORC?
ORC is Oxidized Regenerated Cellulose. Cellulose is plant based bacterial which is chemically oxidized and regenerated to improve the absorption capacity of the material, without affecting its compatibility with human body parts
What does Surgi-ORC® look like?
Surgi-ORC® is a resorbable oxidized cellulose material in a sterile fabric meshwork. When Surgi-ORC® is applied to the bleeding area, it swells into a brownish/black gelatinous mass that aids in the clotting process.
For additional Info: https://doi.org/10.1016/j.carbpol.2019.115585
What is the hemostatic mechanism of action of Surgi- ORC®?
When Surgi- ORC® haemostat when comes in contact with blood, it forms a brownish or black gelatinous mass. This gelatinous mass acts as a physical matrix to which platelets can adhere. With platelet aggregation and formation of platelet-fibrin plug, meanwhile, the swelling material generates pressure on the surrounding tissue contributing to haemostasis.
What are different variants in Surgi – ORC®?
Surgi – ORC® is available in four variants viz. ORIGINAL, KNIT, FIBRIL and NON-WOVEN / SNOW of Surgi-ORC®
What is the time to achieve haemostasis or stop bleeding with Surgi- ORC®?
It generally takes 3 to 4 minutes to stop bleeding or achieve Hemostasis with Surgi ORC®
What is Surgi-ORC® used for?
Surgi-ORC® is a sterile cellulose based thrombogenic material used to control bleeding originating from delicate and/or friable tissues. It is commercially available as a gauze like material and is generally inert and bio absorbable.
Is Surgi-ORC® Absorbable?
Yes, Surgi-ORC® Absorbable
Surgi-ORC® Original, Fibril and Knit absorbable haemostats are composed of oxidized regenerated cellulose and are sterile, absorbable knitted fabrics that are flexible and adhere readily to bleeding surfaces.
For additional Info: https://doi.org/10.1021/acsbiomaterials.7b00382
How long does it take Surgi-ORC® to absorb?
Absorption depends on; Haemostat amount used, tissue type and blood saturation degree. Generally, it is completely absorbed within 7-14 days.
For additional Info: https://doi.org/10.1016/j.carbpol.2012.01.058
Does Surgi-ORC® Dissolve?
Surgi-ORC® decreases the pH of its surroundings. The dissolution of Surgi-ORC® depends on the quantity, site of implantation and the environmental factors, and the process may last for between 7-14 days.
For additional Info: https://doi.org/10.1007/s10353-013-0222-z
Can Surgi-ORC® be cut into different dimensions?
Yes, Surgi-ORC® Haemostat can be cut into the desired dimension.
Surgi-ORC® Haemostats is already available in different dimensions as required in market and as per different surgical conditions. However, as per need surgeon can also further cut them into desired dimensions prior to usage.
Can Surgi-ORC® be used in on-site Emergency situation?
Surgi-ORC® is an adjunctive Haemostats. It can be used assist to control bleeding from capillary, venous and small arteriolar vessels. In emergency/trauma situation Surgi-ORC® can assist well in Haemostasis & serve as a haemostatic adjunct in the control of local haemorrhage.
For additional Info: https://doi.org/10.1186/s12893-018-0398-z
What are specific Indications of Surgi- ORC® Variants?
Surgi – ORC®, ORIGINAL is indicated for use in
Cardiovascular and Thoracic Surgery: Anastomotic sites
General Surgery: Cholecystectomy, Liver and Spleen Laceration, Port Site Bleeding
ENT Surgery: Tonsillectomy
Plastic Surgery: Skin Grafting
Surgi – ORC®, KNIT is indicated for use in
Cardiovascular and Thoracic Surgery: Cannulation sites, Anastomotic sites in CABG and Valve Repair/ Replacement
General Surgery: Liver Transplant, Resection and Repair, Splenic Injury
Surgi – ORC®, FIBRIL is indicated for use in
Neurosurgery: Epidural Oozing and Capillary Oozing during Craniotomy, Laminectomy, Surgery on Tumour Bed, Head Trauma, Spine and Spinal Cord Surgeries
Cardiovascular and Thoracic Surgery: Carotid Endarterectomy, Abdominal Aortic Aneurysm, Sternum Closure in CABG and Valve Repair/Replacement
Orthopaedic Surgery: Femur Shaft Reduction and Fixation
Surgi – ORC® NON-WOVEN / SNOW is specifically indicated for use in
Gynaecological Surgeries: Laparoscopic hysterectomy
However, the use of the Surgi ORC® variants in different surgeries is left to the discretion of the Physician.
Which type of Haemorrhage (i.e. oozing, spurting, mild, moderate) is best managed by the agent?
Surgi-ORC® can be effective to continuous Bleeding to moderate bleeding conditions.
For additional Info: https://doi.org/10.2147/oaem.s205006
Is the agent effective to control fluid leakages (biliary, pancreatic, urinary)?
Surgi-ORC® haemostat should not be used on non-haemorrhagic serious oozing surfaces, since body fluids, except whole blood, such as serum, do not react with Surgi-ORC® haemostat to give satisfactory results.
Does the antibacterial property of Surgi-ORC® depend on any external agent?
No, Antibacterial Activity of Surgi-ORC® does not depend on any external agent.
The antibacterial property of Surgi-ORC® is due to the inbuilt bactericidal characteristic of Oxidized Regenerated Cellulose itself. The pH of Oxidized Cellulose created by oxidation of cellulose, tends to inhibit the growth of microorganisms including some strains of antibiotic resistant organisms.
For additional Info: https://doi.org/10.1089/109629603322419599
Can Surgi-ORC® control Infection?
Surgi-ORC® haemostat is bactericidal in vitro against a wide range of gram positive and gram negative organisms including aerobes and anaerobes. The antibacterial property helps in prevention of Surgical Site infection which can occur during the surgery, however, Surgi-ORC® haemostat is not an alternative to the systemically applied therapeutic or prophylactic antimicrobial agents.
Can Surgi-ORC® be used in Packing of surgical wounds or Surgical sites?
Surgi-ORC® is not recommended to be used in packing and wadding on surgical sites as it may create difficulty for drainage and exert unwanted pressure.
Can Surgi-ORC® be left on wound?
Surgi-ORC® must always be removed after haemostasis is achieved, since it will swell and could exert unwanted pressure. The minimum effective amount of oxidized cellulose-based topical haemostatic should be used, and excess material not contributing to haemostasis should be removed, because of the risk of foreign body reactions.
Can Surgi-ORC® be used in moistened condition?
Surgi-ORC® haemostats should not be moistened with water or saline as it may affect the haemostasis effect. The haemostatic effect of Surgi-ORC® Absorbable Haemostat is greater when it is applied dry.
Can Surgi-ORC® be used in patients with Coagulation Disorder?
Topical hemostats are not intended for primary treatment of coagulation disorders hence included in IFU under warnings. However, topical hemostats like Fibrin related sealants and adhesives can be used as adjuvants for achieving hemostasis in patients with coagulation disorders
For additional Info: https://dx.doi.org/10.1186%2Fs12893-018-0398-z
What other brands of Oxidized Regenerated Cellulose are available in the International market?
Surgicel from Ethicon
What is PVA?
The sponges consist of PVA (polyvinyl alcohol) material which is capable of absorbing fluid several times of their own weight. All the SURGI-PVATM ENT sponge are available in various styles and sizes with or without strings/threads and airway tubes. The dimensions of SURGI-PVATM ENT sponges are approximate and based on the product in fully hydrated state.
What is Surgi-PVA Sponge made up of?
The sponges consist of PVA (polyvinyl alcohol) material which is capable of absorbing fluid several times of their own weight.
For additional Info: http://www.pvasponge.com/images/Introduction_to_PVA_Sponge.pdf
When is Surgi-PVA Used?
SURGI-PVATM ENT Sponges are intended to be used for placing inside the nasal cavities or ear canal for epistaxis and post-operative surgery, which expands when moistened to assist in management of fluids i.e. fluid control and drainage control and tamponade or haemostasis.
SURGI-PVATM Ophthalmic Sponges are intended to be used in ophthalmic or microscopic surgical procedures to assist in absorbing excess fluids from the operative field in management of fluid i.e. fluid control and drainage control.
For Additional Info: https://www.ent-cyprus.com/en/nose/functional-endoscopic-sinus-surgery-fess/
How Do you use Surgi-PVA?
Please refer the Below IFU Link – USER PROCEDURE for method of usage of PVA Sponges.
Can Surgi-PVA be cut into different dimensions?
No, Surgi-PVATM is available in different dimensions and shapes required in different surgeries. Further, it need not to be cut in different dimensions.
Is Surgi-PVA Sponge Absorbable?
No. Surgi- PVATM is not Absorbable.
For Additional Info: https://www.ejo.eg.net/text.asp?2018/34/4/253/244885
Can Surgi-PVA be moistened with Organic Solvents?
No, Surgi-PVATM Sponges is strictly prohibited to contact the PVA sponge with organic solvents.
Does Surgi-PVA Exhibit Antimicrobial properties?
SURGI-PVATM Sponge exhibits no antimicrobial properties, they are not bacteriostatic towards pre-existing infections, nor do they prevent the occurrence of new infections. In the case of pre-existing infections, it is recommended that appropriate treatment should be instituted.
Can Surgi-PVA be moistened with Alcoholic Solvents?
SURGI-PVATM Sponge is not suitable to be moistened with an alcoholic solution, as the structure of sponge may change.
How long do you leave Surgi-PVA on?
After placement of the product more than three days, the evaluation by physician is suggested for further usage.
Is Nasal Packing Essential after Functional Endoscopic Sinus Surgery (FESS)?
Yes, Nasal packing is important in critical nasal surgeries, however its left to the discretion of ENT surgeon on usage of nasal packing after FESS
For Additional Info: https://doi.org/10.5005/jp-journals-10013-1320
What other brands of PVA Sponges are available in the International market?
Merocel from Medtronic
