Efficacy And Safety Of A Novel Hemostatic Agent Made From Gelatin Sponge

Background:Bleeding is a very common thing during surgery,but it is also very important.Effective hemostasis can show the operative visual field more clearly,decrease operation time,lower the morbidity and mortality related to operation.and reduce perioperative blood transfusion,postoperative drainage and the occurrence of related complications.Currently,there appear many kinds of hemostatic methods used in clinic,including mechanical hemostasis(such as suture hemostasis,gauze pressing hemostasis,hemostatic clip,etc.),thermal technology(such as bipolar hemostasis,laser,etc.),chemical technology(such as venous hemostatic drugs,local hemostatic agents,local sealants or adhesives,etc.).In recent years,as a local hemostatic agent,gelatin sponge has been widely used in various surgical operations and has been proved to be safe and effective.It can be used alone or in combination with other drugs.With the deepening and combination of clinical practice and basic research,many new gelatin sponge products have emerged,which have better hemostatic function and are more convenient to use.However,when there are irregular and deep bleeding on the surface during the operation,such as the bleeding of the venous plexus around the spinal cord during spinal surgery,the above conventional methods are either ineffective or not feasible at all,so in recent years,a class of fluid local hemostatic agents named Surgiflo(?)and Floseal(?)have appeared abroad.This fluid local hemostatic agent has excellent hemostatic effect during operation,and sometimes it plays an irreplaceable role.However,there are only imported products on the market,and the local hemostatic agent is expensive,so there is an urgent need to develop a domestic hemostatic material with similar hemostatic effect and good safety.After further processing and improvement of gelatin sponge,we have invented a new type of fluid gelatin sponge hemostatic material.Objective:In order to provide theoretical basis for further application of the novel gelatin sponge hemostatic agent in clinic,this paper analyzes and evaluates the effectiveness and safety of the novel gelatin sponge hemostatic material through a variety of real test methods.Methods:In terms of effectiveness,the hemostatic properties of the new fluid gelatin were compared and analyzed through in vivo experiment:rabbit liver hemorrhage model test,in vitro experiment:dynamic coagulation test and red blood cell aggregation test.In terms of safety,through in vivo experiments:rat histocompatibility test,mouse acute systemic toxicity test,in vitro experiment:hemolysis test,to explore whether the new gelatin sponge hemostatic material can induce obvious pathological reactions and adverse events.Results:In vivo experiment:rabbit liver bleeding model test showed that the hemostatic speed of the new gelatin sponge was faster than that of the gelatin sponge,and the novel gelatin sponge hemostatic material combined with thrombin was the fastest.In vitro experiment:dynamic coagulation test and erythrocyte aggregation test showed that the coagulation effect of the novel one was better than that of gelatin sponge in vitro,and the combination of thrombin and thrombin could improve the hemostatic effect.In terms of safety,through the in vivo experiment:there was no obvious inflammatory reaction or pathological change in the histocompatibility test of rats at each test time point.The acute poisoning test of the whole body of mice showed that the general condition of the two groups of mice was good,non-toxic reaction and death.In vitro experiment:the novel gelatin sponge hemostatic material in hemolysis test had no hemolysis.Combined with in vivo and in vitro tests,no pathological changes and adverse outcomes caused by new gelatin sponge hemostatic materials were found.Conclusion:As a new fluid local hemostatic agent,the novel gelatin sponge hemostatic material is a safe,reliable and more effective hemostatic method,and it has a very broad prospect in intraoperative hemostasis.