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Efficacy, safety, and physicochemical properties of a flowable hemostatic agent made from absorbable gelatin sponge via vacuum pressure steam sterilization.
Journal of Biomaterials Applications ( IF 2.3 ) Pub Date : 2020-08-24 , DOI: 10.1177/0885328220950899
Yuanxing Zhou 1, 2 , Xiaochi Ma 1, 2 , Zhonghai Li 1, 2 , Bo Wang 1, 2
Affiliation  

An effective and viable hemostatic agent is important for stopping bleeding during surgery. However, it is difficult to achieve hemostasis at uneven or deep bleeding sites using a gelatin sponge. A flowable hemostatic agent has therefore been developed by processing and improving gelatin sponge, to address bleeding under these conditions. In this study, we evaluated the efficacy, safety, and physical and chemical properties of this flowable hemostatic agent in various experiments. We examined its efficacy for stopping bleeding in a rabbit model of liver abrasion in vivo, and compared its efficacy in dynamic coagulation and erythrocyte aggregation tests with gelatin sponge in vitro. We also investigated its safety in rat histocompatibility and acute systemic toxicity tests in mice in vivo, and in hemolysis tests in vitro, to determine if the flowable hemostatic agent induced any pathological reactions or adverse events. In terms of its physical and chemical properties, we analyzed the morphology and chemical bonds of the flowable hemostatic agent by optical and electron microscopy and infrared spectroscopy, and its absorbency and density. The flowable hemostatic agent resulted in a shorter mean bleeding time, less bleeding, greater likelihood of successful hemostasis, and reduced clotting time compared with gelatin sponge. The flowable agent produced some changes in physical morphology, but no pathological changes or undesirable outcomes were detected. This flowable topical hemostatic agent thus provides a safe and more effective hemostatic method than gelatin sponge, and more promising results for intraoperative hemostasis, especially on uneven or deep bleeding surfaces.



中文翻译:

由可吸收明胶海绵真空压力蒸汽灭菌制成的流动止血剂的功效、安全性和理化性质。

有效且可行的止血剂对于在手术期间止血很重要。然而,使用明胶海绵很难在不均匀或较深的出血部位实现止血。因此,通过加工和改进明胶海绵开发了一种可流动的止血剂,以解决这些条件下的出血问题。在本研究中,我们在各种实验中评估了这种可流动止血剂的功效、安全性以及理化性质。我们在体内检查了它在兔肝脏磨损模型中止血的功效,并在体外用明胶海绵比较了它在动态凝血和红细胞聚集试验中的功效。我们还研究了其在大鼠组织相容性和小鼠急性全身毒性试验中的安全性体内体外溶血试验,以确定可流动止血剂是否引起任何病理反应或不良事件。在其理化性质方面,我们通过光学、电子显微镜和红外光谱分析了流动止血剂的形貌和化学键,以及它的吸光度和密度。与明胶海绵相比,可流动止血剂的平均出血时间更短,出血更少,成功止血的可能性更大,凝血时间更短。可流动剂在物理形态上产生了一些变化,但未检测到病理变化或不良结果。因此,这种可流动的局部止血剂提供了比明胶海绵更安全、更有效的止血方法,为术中止血提供了更有希望的结果,

更新日期:2020-08-25
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