Safety evaluation of a low-heat producing zeolite granular hemostatic dressing in a rabbit femoral artery hemorrhage model

摘要

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.