Background/Aim: For the treatment of different tissue defects such as jawbone defects, open wound defect, chronic ulcers, dura mater defects and corneal defects, different biomaterials are available. The use of collagen-based materials for these applications has been significantly increased over the past decades due to its excellent biocompatibility and degradability. However, no transparent collagen-based biomaterial is available until now. Thus, a newly developed transparent collagen membrane (TCM) based on natural derived porcine pericardium, which offers numerous application possibilities, was developed. The present study aimed to analyze the in vitro and in vivo biocompatibility using established methods. Materials and Methods: The new TCM membrane and a commercially available collagen membrane (CM, Jason membrane, botiss biomaterials GmbH, Zossen, Germany) were tested for its in vitro cytocompatibility. Furthermore, the in vivo biocompatibility was analyzed using sham operations as control group. In vitro, cytocompatibility was tested in accordance with EN ISO 10993-5/-12 regulations and Live-Dead-stainings. In vivo, a subcutaneous implantation model in BALB/c mice was used and explants were prepared for analyses by established histological, immunohistochemical and histomorphometrical methods. Results: In vitro, both membranes showed promising cytocompatibility with a slightly better direct cell response in the Live-Dead staining assay for the TCM. In vivo, TCM induced a comparable inflammatory immune response after 10 and 30 days with comparable numbers of M1- and M2-macrophages as also found in the control group without biomaterial insertion. Conclusion: The newly transparent collagen membrane is fully biocompatible and is supporting safe clinical application in tissue repair and surgery.

中文翻译：

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用于不同临床适应症组织再生的新型透明胶原基伤口膜的体外和体内生物相容性分析

背景/目的：对于不同的组织缺损，如颌骨缺损、开放性伤口缺损、慢性溃疡、硬脑膜缺损和角膜缺损，有不同的生物材料可供选择。由于其出色的生物相容性和可降解性，在过去的几十年中，胶原基材料在这些应用中的使用已显着增加。然而，到目前为止，还没有透明的基于胶原蛋白的生物材料可用。因此，开发了一种新开发的基于天然衍生猪心包的透明胶原膜 (TCM)，它提供了多种应用可能性。本研究旨在使用既定方法分析体外和体内生物相容性。材料和方法：新型 TCM 膜和市售胶原膜（CM、Jason 膜、botiss biomaterials GmbH、Zossen, Germany) 进行了体外细胞相容性测试。此外，使用假手术作为对照组分析体内生物相容性。在体外，根据 EN ISO 10993-5/-12 规定和活死染色测试了细胞相容性。在体内，使用了 BALB/c 小鼠的皮下植入模型，并通过已建立的组织学、免疫组织化学和组织形态计量学方法制备了用于分析的外植体。结果：在体外，两种膜都显示出有希望的细胞相容性，在 TCM 的活-死染色试验中，直接细胞反应略好。在体内，TCM 在 10 天和 30 天后诱导了相当数量的 M1 和 M2 巨噬细胞的炎症免疫反应，这在没有插入生物材料的对照组中也发现。结论：