What is Tisseel used to treat?
Hemostasis: Tisseel is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. Tisseel is effective in heparinized patients.
How long has Tisseel fibrin sealant been used?
For more than 40 years, TISSEEL fibrin sealant has been trusted worldwide for proven hemostasis and sealing*.
What is Tisseel made of?
Tisseel 1 Fibrin sealant is made of two substances from human plasma... 2 Important Information. You should not be treated with Tisseel if you are allergic to cows... 3 Before taking this medicine. You should not be treated with Tisseel if you are allergic to cows... 4 Tisseel can be sprayed or dripped onto...
What is the generic name for Tisseel?
Tisseel. Generic Name: fibrin sealant topical (FYE brin SEE lant TOP i kal) Brand Name: Artiss, Artiss Duo Set, Artiss Duploject, Tisseel, Tisseel Duploject Kit, Tisseel Valupak Kit
What is tisseel made out of?
TISSEEL is made from human plasma. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically the Creutzfeldt-Jakob disease (CJD) agent.
Is tisseel a medication?
Tisseel is used to help control bleeding during surgery when other ways to close a wound or incision (such as stitches, bands, or heat) cannot be used. This medicine may also be used to prevent leaks from a wound left in stomach tissue after a colostomy is removed.
How long is tisseel good for?
Transfer inner pouch with pre-filled syringe onto the sterile field. Maintain the product at 33-37°C until use. Once the package is opened or the product is warmed to 33-37°C, it must be used within 4 hours. Room Temperature Thawing: Unopened pouches can be stored for up to 48 hours at room temperature (15-25°C).
How long does tisseel take to set?
As a guideline for the gluing of surfaces, 1 pack of TISSEEL Ready to use 2 ml (i.e. 1 ml Sealer Protein Solution plus 1 ml Thrombin Solution) will be sufficient for an area of at least 10 cm2....Instructions:Pack SizeMinimum Thawing/Warming Times 33°C to 37°C, Incubator Product in bags4 ml50 minutes10 ml90 minutes1 more row
How long does fibrin glue last?
Biodegradation of this fibrin sealant occurs over 30 days [65]. The effectiveness of this product has been demonstrated in a multicenter, prospective, randomized trial [65, 70] including cardiac, hepatic [71], general surgical, and orthopedic patients (cancellous bone bleeding) [72].
How do you use tisseel?
TISSEEL must be sprayed only onto application sites that are visible. Dry the site of application as much as possible. The surface area of the wound needs to be dried using standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
How do you mix tisseel?
2:449:19Preparation and Application of TISSEEL - YouTubeYouTubeStart of suggested clipEnd of suggested clipPlace the sealer protein vial back into the largest opening of the fiber in a Thurm device with theMorePlace the sealer protein vial back into the largest opening of the fiber in a Thurm device with the appropriate adapter if needed and activate the magnetic stirring by pressing the green switch.
Is Vistaseal the same as tisseel?
VISTASEAL components undergo dual nanofiltration, while TISSEEL undergoes a high temperature two-step vapor heating process, which can potentially have detrimental effects on the proteins; however, the clinical relevance of this is unclear [39].
What is tisseel used for in surgery?
Hemostasis: Tisseel is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.
How long is Vistaseal good for once thawed?
Post-Thawing Storage: After thawing, the kit containing the VISTASEAL syringe holder with pre-filled syringes and Dual Applicator can be stored before use for not more than 48 hours in the refrigerator at Page 3 labeltext-fs-rev01Jun2022_clean 2 - 8 °C [36 - 46 °F] or 24 hours at room temperature (20 - 25 °C [68 - 77 ° ...
What is Evicel fibrin sealant?
EVICEL® is a Fibrin Sealant (Human) indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical (1)
What is tisseel used for in surgery?
Hemostasis: Tisseel is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.
How do you pronounce tisseel?
0:011:09Pronunciation of the word(s) "Tisseel Fibrin Sealant". - YouTubeYouTubeStart of suggested clipEnd of suggested clipEu disse Fiber.MoreEu disse Fiber.
What is the side effects of fibrin?
Side Effectschest pain, cough, trouble breathing, gasping for breath;confusion, agitation, panic, extreme fear;sudden numbness or weakness (especially on one side of the body);sudden severe headache, slurred speech, problems with vision or balance;blue-colored appearance of your skin or lips;More items...•
How do you cook tisseel?
2:449:19Preparation and Application of TISSEEL - YouTubeYouTubeStart of suggested clipEnd of suggested clipPlace the sealer protein vial back into the largest opening of the fiber in a Thurm device with theMorePlace the sealer protein vial back into the largest opening of the fiber in a Thurm device with the appropriate adapter if needed and activate the magnetic stirring by pressing the green switch.
Before Taking This Medicine
You should not be treated with Tisseel if you are allergic to cows or products made from cows.It is not known whether Tisseel will harm an unborn b...
How Should I Use Tisseel?
Tisseel can be sprayed or dripped onto the affected skin or surgical area. This medicine is applied by a healthcare professional in a surgical or c...
What Happens If I Overdose?
Since this medicine is applied by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What Other Drugs Will Affect Tisseel?
It is not likely that other drugs you take orally or inject will have an effect on topically applied fibrin sealant. But many drugs can interact wi...
Mimics Physiological Clot
TISSEEL contains a unique formulation of fibrinogen and thrombin which, upon mixing, mimics a physiological clot. The aprotinin in TISSEEL increases resistance of the fibrin sealant clot to degradation in a fibrinolytic environment 1.
Mechanism of Action
Upon mixing, human sealer protein and human thrombin combine into fibrin that adheres to the wound surface and achieves hemostasis and sealing. TISSEEL mimics the final coagulation cascade step by forming a clot. Learn more about how TISSEEL works.
Wide Range of Applicators
TISSEEL is the only fibrin sealant to offer a complete portfolio of drip and spray applicators, allowing surgeons to select the right tools to address individual patient needs.
Precise Placement
The DUPLOSPRAY System allows for bleeding to be targeted laparoscopically by getting as close as 2-5 cm to the tissue¹.
Mimics Physiological Clot
TISSEEL contains a unique formulation of fibrinogen and thrombin which, upon mixing, mimics a physiological clot. The aprotinin in TISSEEL increases resistance of the fibrin sealant clot to degradation in a fibrinolytic environment 1.
Mechanism of Action
Upon mixing, human sealer protein and human thrombin combine into fibrin that adheres to the wound surface and achieves hemostasis and sealing. TISSEEL mimics the final coagulation cascade step by forming a clot. Learn more about how TISSEEL works.
Wide Range of Applicators
TISSEEL is the only fibrin sealant to offer a complete portfolio of drip and spray applicators, allowing surgeons to select the right tools to address individual patient needs.
Precise Placement
The DUPLOSPRAY System allows for bleeding to be targeted laparoscopically by getting as close as 2-5 cm to the tissue¹.
Are you interested in additional information about TISSEEL?
This abbreviated summary of product characteristics (SPC) is intended for international use. Please note that it may differ from the licensed SPC in the country where you are practicing.
What is a tisseel sealant?
Tisseel Fibrin Sealant ( fibrinogen human, human thrombin kit) is a fibrin sealant used as an adjunct to hemostasis in adult and pediatric patients (older than 1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.
Why do we use tisseel?
Tisseel is also indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.
What is a tissel?
TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade.
How long does it take for a tissel to be resorbed?
Pharmacokinetic studies were not conducted. TISSEEL is expected to be completely resorbed in 10 to14 days
What is sealer protein?
Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin or as a finished frozen solution pre-filled into one side of a dual-chambered syringe.
How is tissel made?
TISSEEL is made from pooled human plasma collected at US licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma (see WARNINGS AND PRECAUTIONS ). Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions representative of respective manufacturing steps.
Is tissel approved by the FDA?
The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated, and its use in this setting is not approved by FDA (see ADVERSE REACTIONS and DRUG INTERACTIONS ).
What is a tissel?
TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade.
What is the name of the protease that transforms the fibrinogen contained in sealer protein into fibr?
Thrombin is a highly specific protease that transforms the fibrinogen contained in Sealer Protein (Human) into fibrin. Fibrinolysis inhibitor, Aprotinin (Synthetic), is a polyvalent protease inhibitor that prevents premature degradation of fibrin. Preclinical studies with different fibrin sealant preparations simulating the fibrinolytic activity generated by extracorporeal circulation in patients during cardiovascular surgery have shown that incorporation of aprotinin in the product formulation increases resistance of the fibrin sealant clot to degradation in a fibrinolytic environment.
What is the minimum bleeding required for tissel?
Subjects were randomly assigned to TISSEEL or control when persistent bleeding at the study suture line was present after surgical hemostasis, i.e., sutures. Eligible bleedings before clamping and treatment application were defined as a minimum of 25% of the suture line bleeds or at least 5 suture line bleedings or any pulsatile or spurting needle hole bleeding. For the primary endpoint, hemostasis achieved at the study suture line at 4 minutes and maintained until surgical closure, a single application of TISSEEL was statistically significantly superior to control (p<0.0001; likelihood ratio chi-square test; 2.5% one sided) [ITT].
Can tissel cause anaphylaxis?
Hypersensitivity reactions including allergic/and anaphylactoid reactions can occur with the use of TISSEEL. Cases have been reported in post marketing experience with Baxter’s fibrin sealant (see Adverse Reactions (6.2) ). In specific cases, these reactions have progressed to severe anaphylaxis. Such reactions may especially be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously. Even if the first treatment was well tolerated, this may not exclude the occurrence of an allergic reaction after a subsequent administration of TISSEEL or systemic aprotinin. Observed symptoms of allergic anaphylactic reactions to TISSEEL have included: bradycardia, tachycardia, hypotension, flushing, bronchospasm, wheezing, dyspnea, nausea, urticaria, angioedema, pruritus, erythema and paresthesia. Such reactions can also occur in patients receiving TISSEEL for the first time.
Can you use tissel with a duct sealant?
Apply TISSEEL using the DUPLOJECT Fibrin Sealant Preparation and Application System or an equivalent delivery system (including open and minimally invasive spray devices) cleared by FDA for use with TISSEEL. Specific instructions for the use of TISSEEL in conjunction with each cleared delivery device are provided with the device.
Is tissel a fibrin sealant?
TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.
Can a fibron sealant cause an air embolism?
This can occur if a spray device is used at higher than recommended pressures and in closer than recommended proximity to the tissue surface. The solubility of compressed CO 2 is greater than either compressed N 2 or Air thereby reducing the potential effect of embolization.
warnings
You should not be treated with fibrin sealant topical if you are allergic to cows or products made from cows.
Side Effects
Get emergency medical help if you have signs of an allergic reaction: hives, itching, warmth, redness, numbness, tingly feeling; nausea, vomiting, feeling light-headed, fast or slow heartbeats; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.
Pregnancy & Breastfeeding
It is not known whether fibrin sealant topical will harm an unborn baby. Tell your doctor if you are pregnant.
Interactions
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
Use Tisseel (Fibrin Sealant Topical) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Overdose Signs
Since this medicine is applied by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What is fibrin glue used for?
In eye care, fibrin glue is often used in pterygium repair, or at the end of vitreoretinal surgery. Generally, it's most useful when you need to work with the conjunctiva.
What glue is used for glaucoma surgery?
Currently, the Tisseel brand is the only glue I'm aware of that makes sense to use in glaucoma surgery. Its texture, consistency and other characteristics make it ideal for this purpose. Other glues are now being developed, but for this type of surgery Tisseel seems to be the most viable current option.
What glue do you use for canaloplasty?
We're also now using fibrin glue in our canaloplasty and some ECP cases. In canaloplasty, where the scleral flap is closed tightly, we use fibrin glue to close the conjunctiva at the end of the case; we also use it to supplement our suture closure of the scleral flap to buy us a margin of error if there is some minimal leakage. In ECP cases in which we have a vitrectomized, non-phakic eye, we often prefer to use a pars plana approach. After closing sclerostomies at the end of the case with vicryl sutures, we use the glue for conjunctival closure as well.
Why do we use fibrin glue?
We use the glue for two purposes: to repair wound leaks and to create a space under the conjunctiva that's free of blood and scarring.
How to use fibrin glue in glaucoma?
The easiest way to use fibrin glue in glaucoma surgery is the first way we used it: as a means to glue the conjunctiva back in place at the end of a case. We first tried this when implanting tube shunts such as the Ahmed or Baerveldt; we found that by using the glue for closure instead of multiple sutures we could accomplish this phase of the case in a couple of minutes. It's so quick and effective that we ended up using it during closure in every case.
How to glue conjunctiva?
At this point, assuming your goal is to fasten the conjunctiva in place, you move the tissue into the position in which you want it to remain. If you've mixed the glue away from the eye, you then squirt some of it under the tissue and push the tissue down into the glue using forceps or a Weck-Cel. After about 15 seconds it stays where you placed it. This is not as precise or elegant as you might think would be necessary, but it works extremely well.
Can you glue sutures in the operating room?
I and my recent fellows, Malik Kahook, MD, Larissa Camejo, MD, and Michael Herceg, DO, have found the glue to be very useful, so we always keep it on hand in the operating room. If we encounter a difficult situation—say the conjunctival tissue is falling apart, and placing sutures is causing further problems—we can simply glue the tissue into place.
