MacDonald Melinda H, Wang Allen Y, Clymer Jeffrey W, Hutchinson Richard W, Kocharian Richard
Ethicon Inc., Somerville, NJ, USA.
Med Devices (Auckl). 2017 Nov 30;10:273-279. doi: 10.2147/MDER.S140663. eCollection 2017.
Usage of topical hemostatic agents in surgery is increasing, including use during minimally invasive procedures, and even for surgeries that have a low risk of bleeding complications. A novel product, Surgicel Powder - Absorbable Hemostatic Powder (SP), made from oxidized regenerated cellulose (ORC) fabric, has been developed for adjunctive use in surgical procedures to assist in control of oozing bleeding over broad areas and where access could be difficult with a fabric ORC product. This study compares the new SP to other commercially available hemostatic powder products in two in vivo models.
Hemostatic efficacy of SP was compared to two polysaccharide-based hemostats in a porcine liver punch biopsy model and to three polysaccharide-based hemostats and one non-regenerated oxidized cellulose hemostat in a porcine liver abrasion model. Primary outcomes measured were hemostatic efficacy, defined as hemostasis within 10 minutes of application, and time-to-hemostasis (TTH).
In the punch biopsy model, SP displayed significantly higher effective hemostasis rates than one of the polysaccharide hemostats (=0.047) and faster TTH than both (<0.001). In the liver abrasion model, SP had significantly higher effective hemostasis rates (≤0.002) and faster TTH (<0.001) than the other four hemostatic agents. The amount of powder applied within the ranges used did not appear to affect hemostatic efficacy.
In both the liver punch biopsy model of mild to moderate bleeding and the liver abrasion model of mild but diffuse oozing, SP provided more effective hemostasis and faster TTH than other marketed hemostatic powders. The results from this in vivo study suggest that Surgicel Powder may be useful in clinical applications where control of oozing capillary, mild venous, and small arterial hemorrhage is required including bleeding in difficult-to-access locations.
手术中局部止血剂的使用正在增加，包括在微创手术期间使用，甚至用于出血并发症风险较低的手术。一种新型产品，可吸收止血粉（Surgicel Powder，SP），由氧化再生纤维素（ORC）织物制成，已开发用于手术过程中的辅助使用，以帮助控制大面积渗血以及使用织物ORC产品难以触及的部位的渗血。本研究在两种体内模型中将新型SP与其他市售止血粉产品进行比较。
在猪肝穿刺活检模型中，将SP的止血效果与两种基于多糖的止血剂进行比较；在猪肝擦伤模型中，将其与三种基于多糖的止血剂和一种非再生氧化纤维素止血剂进行比较。测量的主要结果是止血效果，定义为应用后10分钟内止血，以及止血时间（TTH）。
在穿刺活检模型中，SP显示出比一种多糖止血剂显著更高的有效止血率（=0.047），并且TTH比两者都快（<0.001）。在肝脏擦伤模型中，SP比其他四种止血剂具有显著更高的有效止血率（≤0.002）和更快的TTH（<0.001）。在所使用的范围内应用的粉末量似乎不影响止血效果。
在轻度至中度出血的猪肝穿刺活检模型和轻度但弥漫性渗血的肝脏擦伤模型中，SP比其他市售止血粉提供了更有效的止血和更快的TTH。这项体内研究的结果表明，可吸收止血粉可能在需要控制毛细血管渗血、轻度静脉出血和小动脉出血的临床应用中有用，包括难以触及部位的出血。
