TISSEEL, human fibrinogen and thrombin-based frozen solution for sealant

• TISSEEL has Marketing Authorisation as supportive treatment where standard surgical techniques appear insufficient:

            - for improvement of haemostasis;

            - as a tissue glue to improve wound healing or to support sutures in vascular surgery and in gastrointestinal anastomoses;

            - for tissue sealing, to improve adhesion of the separated tissue.

• This sealant is intended to replace TISSUCOL KIT although their indications are not identical; TISSUCOL KIT has Marketing Authorisation only as supportive treatment intended to improve local haemostasis during a surgical procedure.

• TISSEEL improves perioperative haemostasis in comparison with manual compression alone, alongside standard methods (that do not use fibrin sealant) during planned hepatic and vascular surgery. However, no contribution towards reducing morbidity and mortality – specifically number of transfusions, repeat surgical procedures, operating time, duration of hospitalisation and death – has been demonstrated.

• In the absence of studies comparing TISSEEL with another fibrin sealant or thrombin-based product, its therapeutic benefit cannot be assessed in relation to the alternatives used in practice.