Safety and Tissue Remodeling Assay of small intestinal submucosa Meshes Using a Modified Porcine Surgical Hernia Model

Abstract

Abstract In studies to date, extracellular matrix (ECM) based meshes have been extensively utilized in clinical applications. Unfortunately, little is known about the function of the immunogenic residual, absorbable profile during the tissue repair process. Moreover, there needs to be a recognized preclinical animal model to investigate the safety and efficacy of extracellular matrix meshes.Herein, we designed and fabricated a kind of SIS mesh followed by a scanning electron micrograph characterization, including α-Gal antigen clearance rate and DNA residual determination. In order to prove the biocompatibility of the SIS mesh, cell viability, chemotaxis assay and local tissue reaction were assessed by MTT and RTCA cytotoxicity test in vitro as well as implantation and degradation experiments in vivo. Furthermore, in the porcine ventral hernia repair investigation, we developed a stable preclinical animal model using laparoscopic plus open hybridization method to evaluate tissue adhesion, explant mechanical performance, and histologic analysis after mesh implantation. More importantly, we for the first time established a semi-quantitative scoring system to examine the ECM degradation, tissue remodeling and regeneration in the modified porcine surgical hernia model.Our results highlight the promising application of the modified porcine ventral hernia model for the safety and efficacy investigation of hernia repair meshes.