Evolution of fibrinogen-coated collagen patch for use as a topical hemostatic agent.

Human fibrinogen and thrombin have been combined and coated onto a collagen patch for use as a topical hemostatic agent. These agents have now been used for many years to induce rapid hemostasis and tissue sealing after various indications including thoracic-, plastic-, pediatric-, liver-, and minimally invasive surgery. The only ready-to-use fibrinogen-coated collagen patch at this moment, the third-generation surgical patch (SP-3), contains no bovine aprotinin (antifibrinolytic protein) in contrast to its precursor SP-2, and is thus devoid of bovine-derived components. In vitro studies have shown equal bioequivalence between SP-2 and SP-3. Various experiments in animal models under normal, stressful, and hyperfibrinolytic conditions showed that SP-3 has comparable tissue sealing properties and also outperformed fibrin sealants alone in some studies. The results from these pre-clinical bridging studies showed that aprotinin is not essential for the therapeutic efficacy of SP-3. In conclusion, SP-3 has evolved into a rapid, ready-to-use adjunct to primary measures for tissue sealing and hemostasis, suitable in cardiovascular-, thoracic-, neuro-, spleen-, kidney-, and liver-surgery.