The Phase II clinical trial is a randomized, controlled clinical study in soft tissue to evaluate the superiority of the Fibrin Patch compared to Surgicel. The primary endpoint will measure time to hemostasis at four minutes and if any re-bleeding occurs during a subsequent six minute observation period. The clinical trial will enroll up to 210 patients, of which at least 100 will receive the Fibrin Patch.
The Fibrin Patch is a breakthrough convergence product being developed by Omrix in collaboration with Ethicon, a Johnson & Johnson company.