Journal of Materials Science: Materials in Medicine ( IF 4.2 ) Pub Date : 2021-09-30 , DOI: 10.1007/s10856-021-06586-8 Melinda H MacDonald 1 , Gary Zhang 1 , Laura Tasse 2 , Daidong Wang 3 , Hector De Leon 4 , Richard Kocharian 1
Topical hemostatic agents have become essential tools to aid in preventing excessive bleeding in surgical or emergency settings and to mitigate the associated risks of serious complications. In the present study, we compared the hemostatic efficacy of SURGIFLO® Hemostatic Matrix Kit with Thrombin (Surgiflo—flowable gelatin matrix plus human thrombin) to HEMOBLAST™ Bellows Hemostatic Agent (Hemoblast—a combination product consisting of collagen, chondroitin sulfate, and human thrombin). Surgiflo and Hemoblast were randomly tested in experimentally induced bleeding lesions on the spleens of four pigs. Primary endpoints included hemostatic efficacy measured by absolute time to hemostasis (TTH) within 5 min. Secondary endpoints included the number of product applications and the percent of product needed from each device to achieve hemostasis. Surgiflo demonstrated significantly higher hemostatic efficacy and lower TTH (p < 0.01) than Hemoblast. Surgiflo-treated lesion sites achieved hemostasis in 77.4% of cases following a single product application vs. 3.3% of Hemoblast-treated sites. On average, Surgiflo-treated sites required 63% less product applications than Hemoblast-treated sites (1.26 ± 0.0.51 vs. 3.37 ± 1.16). Surgiflo provided more effective and faster hemostasis than Hemoblast. Since both products contain thrombin to activate endogenous fibrinogen and accelerate clot formation, the superior hemostatic efficacy of Surgiflo in the porcine spleen punch biopsy model seems to be due to Surgiflo’s property as a malleable barrier able to adjust to defect topography and to provide an environment for platelets to adhere and aggregate. Surgiflo combines a flowable gelatin matrix and a delivery system well-suited for precise application to bleeding sites where other methods of hemostasis may be impractical or ineffective.
中文翻译:
两种局部辅助止血剂在猪脾脏活检穿孔模型中度出血中的止血效果
局部止血剂已成为帮助预防手术或紧急情况下过度出血和减轻严重并发症相关风险的重要工具。在本研究中,我们比较了 SURGIFLO ®的止血效果含凝血酶的止血基质试剂盒(Surgiflo—可流动明胶基质加人凝血酶)与 HEMOBLAST™ 波纹管止血剂(Hemoblast—一种由胶原蛋白、硫酸软骨素和人凝血酶组成的组合产品)。Surgiflo 和 Hemoblast 在四只猪的脾脏上通过实验诱导的出血损伤进行了随机测试。主要终点包括通过 5 分钟内的绝对止血时间 (TTH) 测量的止血效果。次要终点包括产品应用的数量和每个设备实现止血所需的产品百分比。Surgiflo 表现出显着更高的止血功效和更低的 TTH ( p < 0.01) 比 Hemoblast。在使用单一产品后,Surgiflo 治疗的病变部位有 77.4% 的病例实现了止血,而 Hemoblast 治疗的部位为 3.3%。平均而言,Surgiflo 治疗部位所需的产品应用比 Hemoblast 治疗部位少 63%(1.26 ± 0.0.51 对 3.37 ± 1.16)。Surgiflo 提供比 Hemoblast 更有效和更快的止血。由于这两种产品都含有凝血酶以激活内源性纤维蛋白原并加速凝块形成,Surgiflo 在猪脾穿孔活检模型中的卓越止血功效似乎是由于 Surgiflo 作为可延展屏障的特性,能够适应缺陷形貌并提供环境血小板粘附和聚集。