Evidence-based Research And Methodology Validation Research Of Animal Study For Soft Tissue Repair Biomaterials

Soft tissue defect is a major disease in the field of surgical medicine.One of the development tendency of biomaterials in recent years is the repair and replacement of human tissue and organ defects.There are many kinds of biological materials in related fields,some materials have been successfully applied to human clinical,more materials are in development.There are many constraints to the clinical transformation of biomaterials,and one of the most important factors is that the existing animal study methods of biomaterials are different from the actual clinical application.How to evaluate the safety and effectiveness of certain materials for soft tissue defect repair through animal research is an urgent problem.In this paper,evidence-based research methods that had been applied in the medical field for many years are used to comprehensively evaluate the animal research literature on biomaterials used in the repair of soft tissue defects such as intraperitoneal hernia repair and dural repair.The results of evidence-based research showed that there was serious heterogeneity in the design of animal study for soft tissue repair biomaterials.The design elements of different studies,such as animal species,modeling methods,outcome indicators,follow-up time and control Settings,were varied.Therefore,it is necessary to establish standardized animal study methods to scientifically evaluate the clinical application prospects of certain soft tissue repair biomaterials.The standardized animal study methods also improve the clinical conversion efficiency.On the basis of evidence-based research,this study established the animal models of intraperitoneal hernia repair and dural repair.The supporting research methods were developed simultaneously.Approved soft tissue repair devices were used to verify the rationality and scientificity of established research methods.The verification results showed that the rat intraperitoneal model and the supporting research method could fully evaluate the feasibility of the new biomaterials for manufacturing intraperitoneal hernia mesh.The rabbit dural defect model and the supporting research method could fully evaluate the feasibility of the new biomaterials for manufacturing dural substitute.In this study,a variety of physical and chemical modified bacterial cellulose-based biomaterials such as laser drilling and chitosan composite were prepared.The material characterization,biomechanical and other properties were tested.The in vitro cell studies were performed.The animal study methods established in this study were used to research the above bacterial cellulose-based biomaterials.The results showed that the related materials had good histocompatibility.Bacterial cellulose gel film,dry film and methylacryloyl modified chitosan bacterial cellulose composite are feasible for repair of intra-abdominal hernia.Methylacryloyl modified chitosan bacterial cellulose composite also has the feasibility for dural repair.This study further verified the rationality of the established animal study method,which is suitable for verifying the safety and effectiveness of various novel soft tissue repair biomaterials.