Instructions of Compont ® Medical Adhesive

[Trade Name] Compont Medical Adhesive
[Appearance and Main Ingredients] Compont is a colorless transparent fluid. The main ingredient is α-cyanoacrylate, blended with a small amount of additives. Pipettes, adhesive spray bottles, jet-spray pumps or laparoscopic and endoscopic catheters are provided in compliance with specified clinical requirements.
Molecular Formula:

[Specifications] 0.3ml / smear-type, 0.5 ml / smear-type, 0.5 ml / embolism-type, 1.0 ml / smear, 1.0 ml / spray-type, 1.5 ml / spray-type, 2.0 ml / spray-type.
[Indications] Conglutination of surgical incisions and openings of wounds; control of diffuse abdominal viscera bleeding or bleeding due to open craniocerebral injuries to achieve hemostasis; and embolization of esophageal varices.
[Mechanisms] By the interaction with the anions in blood and tissue fluids, the product rapidly aggregates and forms a cured membrane on the applied wound. This membrane possesses a reticular fibrous structure of 2－3μm in diameter under the electron microscope. Inlaying firmly in the wound surface, it facilitates the healing of wounds. The reticular structure, on the other hand, encloses ruptured small blood vessels by blocking blood cells and platelets to efficiently stanch the bleeding. When it is used as an emoblization agent, the polymerized and cured adhesive can block the blood flow. A period of 7-10 days for complete removal of the membrane along with cuticule shedding is expected when the product is applied on the surface; for in vivo application, the adhesive can be gradually degraded and absorbed, and eventually eliminated from the body.
[Precaution]
1, The product is sterilized with osmotic membranes. The one-time-use and open-use spray tools are sterilized with ethylene oxide.
2, The shelf-life is two years since the date of sterilization. Spray tools with the color of the ethylene oxide sterilization indicator unchanged shall not be used.
3, Products with damaged aseptic packaging or expired shelf-life shall not be used.

?[Usage]
I.?????? Conglutination of surgical incisions and openings of wounds
Draw the medical colloid from the ampoule with a sterile pipette in reserve, or inject it into a prepared spray bottle, screw off, and press the sprayer to get the adhesive in reserve. After the bleeding is controlled by conventional approaches, close the subcutaneous layer with interrupted sutures, press both edges of the wound with instruments to form an evenly tight conjunction. Wipe off the blood and exudates on the surface of wound completely. Spray or smear the adhesive along the incision line until it is well distributed on a portion of the wound surface. Keep both edges of this part conjunct for 5-15 seconds until the membrane is cured, and repeat the adhesive spray on the next portion.
When used for the control of bleeding due to open craniocerebral trauma, this agent shall be applied by either smearing or spraying evenly on the margins of wound or damaged bone after the correct alignment of them and instant removal of the blood and exudates. The curing of the membrane will take 5-15 seconds.

II.????? Hemostasis of Wound Surface
Draw the medical adhesive from the ampoule into a prepared spray bottle and screw off. Press the sprayer to get the agent in reserve, or keep the adhesive in the pipette for smearing.
After the bleeding is controlled by conventional methods, isolate the wound from the peripheral with gauze pads to fully expose the bleeding wound. Remove the blood and exudates to obtain a dry and clean wound surface. Spray or smear the adhesive evenly on the surface. As the membrane is cured in 5-15 seconds, hemostasis can be immediately achieved. If there is still bleeding or exudates, clean them with an absorbent and repeat spraying or smearing. Bleeding of deep wounds that is difficult to stop can be effectively treated with sponge smearing of the adhesive and filling pressure on the bleeding sites after rapid absorption of the blood.
Control of the bleeding from deep ruptured organs with instruments or fingers is needed in addition to instant removal of blood or exudates of the wound before spraying or smearing the medical adhesive. Peripheral ligaments, fascia and omentum can be used to reinforce the agglutination.
When used for endoscopic hemostasis of wounds, this agent can be injected into a spray bottle that is closely connected to an endoscopic catheter. Screw off the bottle and spray some adhesive in reserve. After the surgical wound is irrigated with saline, apply electrocoagulation to obviously bleeding sites. After the endoscopic catheter is sent into the abdomen through a 5 mm trocar cannula aiming at the wound surface or bleeding sites 3 cm beneath, press the bottle to spray the adhesive to evenly cover the wound surface. As the membrane is cured in 5-15 seconds, hemostasis will be achieved.
[Contraindication] Purulent wounds
[Note]
1, For active bleeding and vascular hemorrhage, conventional methods should be initially applied to achieve thorough control of the bleeding.
2, It is not appropriate to apply this medical adhesive in the skin or within the margin of wound tissue, otherwise the healing effect will be reduced.
3, Rapid drying of applied adhesive as possible is preferred to increase the bonding strength.
4, Subcutaneous suture closer to the corium for better conjunction of the edges is conducive to the bonding effect.
5, Application of excessive adhesive shall be avoided. Thin and uniform spray / smear film as possible is required to prevent thickness of adhesive that is easily shedding.
6, Unintentional excessive adhesive can be wiped off with gauze within 2 seconds. Undesired conjunction of less sensitive skin can be corrected using acetone solvent. DMSO (dimethyl sulfoxide) can be used as the remover.
7, Spray tools shall be dry, for interaction with water can cause rapid polymerization and cure of the adhesive. Adhered tools can be cleaned with acetone.

III Vascular Embolization of Esophageal Varices
1, Stratified injection under the gastrointestinal endoscope (Sandwich)
Three 2ml syringes filled with 2ml lipiodol in the first two and the medical adhesive in the third are prepared for this procedure. The injection needle is filled in advance with lipiodol. After the target vein is located under the endoscope, rapid intravenous injection with 0.5-2.0 ml/drop of the adhesive is conducted, after which the syringe is filled with lipiodol to inject the rest agent in the needle.
2, Direct injection
Lipiodol or benzyl ester is used as the thinner of this product in a specified proportion based on the size of vascular lesions, the length of blood circulation, and the capacity of vascular embolization.

[Contraindications]
1, Since lipiodol is used in these procedures, those who are allergic to iodine should be excluded; 50% hypertonic glucose is a substitute for them, the usage of which is consistent with Lipiodol.
2, Patients with serious heart and lung diseases, shock, coma, or systemic failure.
3, Patients with neurological abnormalities who do not cooperate.
4, Patients with stomach-renal vascular shunt.
5, Patients who have massive blood accumulated in the stomach that obscure the lesion.

[Note]
1, Spray tools shall be kept dry, for interaction with water can cause rapid polymerization and cure of the adhesive. ?
2, The scope of vascular embolization shall be specified before operation. Preoperative angiography can be performed to determine the conditions of internal and external collateral circulation.
3, Strictly controlled applied amount of the medical adhesive and curing time is required. Complete blocking of abnormal blood flows and abnormal subdiaphragmatic collateral supplies is to needed to prevent ectopic embolization.
4, Skilled professionals that are responsible for the intubation are requested.
5, The duration of the entire procedure of stratified injection shall not exceed 20 seconds. Extubation shall be performed immediately after the injection.
6, Even and rapid injection without interruption is desired. However, excessively abrupt or fast injection should be avoided.
7, Adhered tools can be cleaned with acetone.
This Adhesive is used only by trained professionals for cases strictly indicated.

Packaging labels  

?Disposable

Keep dry

Avoid sun exposure

Handle with care

 [Storage]
This product shall be stored in a corrosive-gas-free, well-ventilated and clean environment with a relative humidity less than 80%, ?and temperature between 0 and 30 ℃.
[Shelf Life] Two years

[Manufacturer] Beijing Suncon Medical Adhesive Ltd.
[Registered Address] Room 3318, 12th Hongda Road, Building B, Economic and Technological Development Zone, Beijing (100176)
[Manufacturer Address] Room 3318, 12th Hongda Road, Building B, Economic and Technological Development Zone, Beijing (100176)
[Post-sale Service] Beijing Suncon Medical Adhesive Ltd.
[Phone] (010) 67865701
[Fax] (010) 67865702
[Website] www.compont.com
[E-mail] service@compont.com