TISSEEL™ Kit, Two component Fibrin Sealant, Steam - treated

TISSEEL [Fibrin Sealant]

The information contained in this page is intended for Indian healthcare professionals only.

TISSEEL™ Kit consists of a two-component fibrin sealant offers highly concentrated human fibrinogen to seal tissue and stop diffuse bleeding.

Indications

TISSEEL™ KIT is used to achieve hemostasis, to seal or glue tissue, and to support wound healing. In certain applications biocompatible material, such as collagen fleece, is used as a carrier substance or for reinforcement.

Indications include, but are not limited to:

Hemostasis: Hemostasis in diffuse bleedings, after joint and bone surgery, adenoidectomy and tonsillectomy as well as after maxillodental surgery in patients with bleeding disorders, sealing of the prostatic bed after prostatectomy.

Sealing: Coating and sealing of vascular prostheses, tympanoplasty, management of C.S.F. fistulae and dura lesions, treatment of premature rupture of the membranes in pregnancy by sealing of the lower amniotic region, air-tight sealing of sutures in lung parenchyma and pleura, of sutures in trachea, bronchus and oesophagus, management of malignant pleural effusion, sealing of the lens after injuries with perforations, sealing of suture lines to prevent leakage of intestinal anastomoses, additional sealing of sutured microvascular anastomoses, etc.

Tissue gluing: Gluing of parenchyma in surgery on the kidney, liver, spleen and pancreas, spongiosa grafting when packing bone cavities and defects, pleurodesis in spontaneous pneumo thorax, fixation of skin grafts and flaps, fixation of osteochondral fragments and implants, gluing of peripheral nerves, plastic surgery after opening of the maxillary sinus etc.

Support of Wound Healing: Skin grafting on devascularised and infected recipient sites, management of skin necrosis and mucosal ulcers, incorporation of homologous bone grafts.

Features

  • Upon mixing Sealer Protein (Human) and Thrombin (Human), it quickly sets to form a white, elastic mass which firmly adheres to the tissue i.e., wound surface and achieves hemostasis and sealing or gluing of tissues1
  • Fibrinogen is converted to fibrin strands that join into net-like matrices2
  • In the course of wound healing the solidified fibrin sealant is completely absorbed

Safety and Efficacy

  • Manufactured using processed,screened pooled human plasma, a vapor heating process, and a solvent detergent process1
  • Satisfactory for use in fully heparinized patients undergoing cardiopulmonary bypass1
  • Tisseel Kit can even be applied in fully heparinized patients(eg extracorporeal circulations)

Important Risk Information

For Topical Use Only. Do not inject TISSEEL directly into the circulatory system. Intravascular application of TISSEEL may result in life-threatening thromboembolic events. Caution should be exercised to minimize any risk of inadvertent intravascular application.

Do not use TISSEEL in individuals with a known hypersensitivity to bovine proteins.

Injection into the nasal mucosa must be avoided, as severe allergic – anaphylactoid reactions have been seen and thromboembolic events may occur.

Do not use TISSEEL for the treatment of severe or brisk arterial bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained.

Hypersensitivity or allergic/anaphylactoid reactions may occur with the use of TISSEEL. Symptoms associated with allergic reactions include: flush, urticaria, pruritus, nausea, drop in blood pressure, tachycardia or bradycardia, dyspnea, severe hypotension and anaphylactic shock. Such reactions may also occur in patients receiving TISSEEL for the first time. Discontinue administration of TISSEEL in the event of hypersensitivity reactions.

Apply as a thin layer. Excessive clot thickness may interfere with the product's efficacy and the wound healing process.

Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. This event appears to be related to use of the spray device at higher than recommended pressures and in close proximity to the tissue surface.

When applying fibrin sealants using a spray device, be sure to use the pressure within the pressure range recommended by the spray device manufacturer.

Exposure to solutions containing alcohol, iodine or heavy metals may cause TISSEEL to be denatured. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of TISSEEL.

TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

References

1. TISSEEL KIT Two-Component Fibrin Selant Steam-treated full Prescribing Information
2. Sierra D, Fibrin sealant adhesive systesm: a review of their chemistry, material properties and clinical applications. J Biomat App 1993;7:309-352

Tisseel is a registered trademark of Baxter International Inc.

Contact Us

India
Phone : +91-124-4500200
Fax : +91-124-4263505

Business hours: 9am-6pm IST