Efficacy and safety assessment of gelatin hemostatic matrix in a burr hole neurosurgical beagle model

Absorbable topical hemostatic agents are indispensable for managing excessive bleeding during neurosurgical and emergency procedures, significantly reducing the risk of serious complications. In the current study, we evaluated the hemostatic efficacy of two commercialized hemostatic agents, SURGIFLO (Ethicon, Johnson & Johnson, USA) and Borayerflo (Jiangxi Borayer Biotechnology Ltd, China), in a cerebral hemorrhage model using Beagle dogs. As a result, both SURGIFLO and Borayerflo achieved 100% hemostasis within 5 min of treatment, with no statistically significant differences observed between the two groups. Additionally, blood test results, including fibrinogen (FIB) level, thrombin time (TT), prothrombin time (PT), International Normalized Ratio (INR), and activated partial thromboplastin time (APTT), demonstrated that both SURGIFLO and Borayerflo matrices exhibited excellent blood compatibility and did not interfere with fibrinogen's role in coagulation. Furthermore, toxicity test results indicated that no adverse reactions were observed post-operatively, confirming the safety of both SURGIFLO and Borayerflo. Consequently, the study validates the comparable safety and efficacy of the Borayerflo to SURGIFLO in terms of preclinical hemostatic efficacy and safety, making it a potential alternative product as a suitable absorbable topical hemostatic agent in the market.