Prospective, randomised, controlled investigation comparing the safety and performance of 032-11 surgical haemostat 2g applicator with FLOSEAL hemostatic matrix as an adjunctive haemostat in cardiac surgery and thoracic surgery
In surgery, some degree of haemorrhage is unavoidable. When the body is under shock and stress haemostasis can be harder to achieve, and can also be impaired by some drugs (eg. heparin or aspirin) or surgical procedures (eg. induced hypothermia). Techniques for maintaining haemostasis in surgery include mechanical (direct pressure, sutures and staples), thermal (electro-cautery and laser), and chemical (pharmacotherapy, topical sealants/adhesives and topical haemostats).
The Victory study is a prospective, randomised, controlled investigation comparing the safety and performance of 032-11 Surgical Haemostat Applicator with FLOSEAL® Haemostatic Matrix as an adjunctive haemostat in cardiac surgery and thoracic aortic surgery.
- 032-11 is a chitosan (crustacean animal derived) based haemostat
- 032-11 does not interact with the blood clotting cascade which may be advantageous in coagulopathic patients
- When activated, a gel patch is formed which acts as a physical barrier to blood loss, and can be absorbed by the body enabling closure of the surgical site without removal of the product
- If adjunct haemostat required during surgery (post CPB), patients randomised to 032-11 or FLOSEAL ® (Market leading haemostat in the UK)
- 200 patients to be randomised over 9 sites
- Commercial trial, study sponsor is called Medtrade
- Randomised patients are followed up at their routine outpatient appointment