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Safety evaluation of a low-heat producing zeolite

  • Aluminum silicate materials were widely used for temporary hemostasis of external wounds. Although they are commonly deemed to be nontoxic, side effects were proved to have some potential risks. In addition to obvious thermal effect and distal thrombosis, other chemical analysis should be performed to validate whether there is active components in the blood circulation system even when there is no obvious distal thrombosis. On the other hand, blood electrolytes disturbance is a safety concern, and this issue has been ignored in previous studies. In this study, a systematic and stringent safety evaluation of aluminium silicate hemostatic agents was performed to provide useful information for their future clinical applications. In this study, a low-heat producing Zeolite Granular Dressing (Z-Granular, Zeo-Innov Medical Technology Co., Ltd, Hangzhou, China) was used as hemostatic agents for safety evaluation in a rabbit femoral artery hemorrhage model. In addition to the time to achieve definite hemostasis and heat producing properties, blood electrolytes concentrations of the rabbits pre- and post-application were measured. Although the in vitro electrolyte concentration tests indicated the significant change of Ca2+ and K+ after the zeolite-accelerated hemostasis, in vivo rabbit model suggested that no obvious blood electrolyte disordered occurred. X-ray photography confirmed that there is no zeolite residual granule remained in the wound sites after the debridement. Element analysis proved that the possibility of these inorganic materials entering the blood circulation is very low. The histological results revealed that no pathological changes resulting from Z-Granular were found. Thus, Zeolite Granular Dressing would be an effective and safe hemostatic agent for emergency arterial bleeding. Furthermore, packing zeolite granules within nonwoven-fabric bags would solve the problem of debridement without compromising their hemostatic efficiency. This is a systematic and stringent safety evaluation of aluminium silicate hemostatic agents and provides useful information for their future clinic applications.To get more news about Профессиональный FАК, you can visit rusuntacmed.com.ru official website.

    Procoagulant supplements deliver additional clotting factors to the wound which then combine with clotting factors already present. Together, these clotting factors increase the rate of blood clot formation. Some of the products deliver human clotting factors while others deliver factors derived from bovine blood (Granville-Chapman, Jacobs, & Midwinter, 2011).

    The only procoagulant supplement approved by the Food and Drug Administration is Combat Gauze™ (Littlejohn, Bennett, & Drew, 2015). This product is actually the third generation of QuikClot® products in which the manufacturer replaced the zeolite with kaolin, a clay containing the active ingredient aluminum silicate. Combat Gauze™ uses gauze dressings impregnated with kaolin. An animal model determined Combat Gauze™ to be as effective as the second generation QuikClot® at controlling hemorrhage without producing excessive heat (Baker, Sawvel, Zheng, & Stucky, 2007).

    Researchers conducting an evidence-based review in an attempt to determine if Combat Gauze™ was safe for controlling hemorrhage in the prehospital setting determined that although not conclusive, the results in support of the product were promising (Gegel, Austin, & Johnson, 2013).

    A side-by side comparison of four hemostatic dressings in an animal model of arterial hemorrhage demonstrated survival superiority associated with the use of Combat Gauze™ (Kheirabadi, Scherer, Estep, Dubick, & Holcomb, 2009). In this study, researchers planned to test each of the products in 10 animals. However, two of the chitosan-based products (HemCon® and Celox™-D) failed to achieve hemostasis in the first six tests and all of the animals died. As a result, the researchers did not test those products in the final four animals.
      December 12, 2022 12:13 AM MST
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