Safety and Efficacy of StopBleed Hemostatic dressing in controlling external bleeding.

Trauma remains one of the leading causes of death and disability in the world. Around 40% of deaths in trauma are due to bleeding or its consequences, establishing hemorrhage as the most common cause of preventable death in this clinical group. StopBleed® is a biocompatible biopolymeric material available in powder and pellet form as a hemostatic dressing. StopBleed® is a fibrous material with an extremely high surface area and an absorption capacity of >3000%. It is applied directly to the wound, where, after coming into contact with blood, it quickly absorbs plasma and aggregates the blood cells and entraps them in its fibrous mesh forming a clot that acts as a mechanical barrier at the bleeding site and stops the bleeding. This mechanism promotes hemostasis independently of the coagulation pathways. The absorption of the blood also causes the concentration of the clotting factor, which triggers the extrinsic pathway and further accelerates the blood coagulation. To date, StopBleed® has been extensively tested through different studies needed in terms of design verification and validation to prove its safety and efficacy in vitro and in vivo, including all classes of animals such as mice, rabbits, and pigs. As most of the research on StopBleed® has been conducted in vitro or in animals, the role of StopBleed® in civilian trauma care is unexplored. Therefore, to address this requirement, we propose conducting the first-in-human trial of StopBleed®