The Use of Russian Endoprostheses to Eliminate Defects of the Auricle: Experimental Analysis

N.A. Daikhes, N.E. Manturova, D. Nazaryan, A.A. Khachatryan, Yu.D. Khesuani, H.M. Diab, A. Machalov, G.G. Arakelyan
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Abstract

Summary. The purposes of the study are to improve the quality of life of patients with congenital atresia or amputation of the external ear. Materials and research methods. In the experiment, two closely related individuals of minipig (domestic dwarf pigs) of the Sus salvanius breed were used as a living biological model. Two minipigs were surgically treated in the operating room under sterile conditions using standard surgical instruments. The surgical phase of the experiment consisted of three stages. All surgical stages were performed under multicomponent total intravenous (IV) anesthesia in the presence of an anesthesiologist. The operations were performed by two surgical teams of 2 surgeons each. The following steps were completed within 120 days: collection of ear cartilage from individuals for isolation and cultivation of chondrocytes; implantation and prefabrication of bioengineered endoprostheses into the muscle sheaths of the parietal region; collection of grafts for histological analysis. All three surgical steps on both minipigs were identical and were performed synchronously. Research results and their analysis. Based on the results of the study, the following conclusions can be drawn: – the domestic endoprosthesis has shown its effectiveness and safety on a biological model; – further study of the proven methodology on a larger number of biological models is necessary; – taking into account the purity of Beta testing, the developed material must be tested in clinical studies; – the use of chondrocytes and cell engineering technologies makes it possible to create safe and effective endoprostheses to eliminate congenital atresia of the auricle.
使用俄罗斯内假体消除耳廓缺陷:实验分析
摘要本研究旨在提高先天性外耳道闭锁或截肢患者的生活质量。材料和研究方法。在实验中,使用了两只亲缘关系很近的苏氏侏儒猪(家养侏儒猪)作为活体生物模型。在无菌条件下,在手术室使用标准手术器械对两只迷你猪进行手术治疗。实验的手术阶段包括三个阶段。所有手术阶段均在麻醉师在场的情况下,在多组分全静脉注射(IV)麻醉下进行。手术由两个手术小组进行,每个小组由两名外科医生组成。以下步骤在 120 天内完成:收集个人耳软骨,用于分离和培养软骨细胞;将生物工程假体植入顶区肌鞘并预制;收集移植物用于组织学分析。两只迷你猪的所有三个手术步骤完全相同,并且同步进行。研究结果及其分析。根据研究结果,可以得出以下结论:--国产假体在生物模型上显示出其有效性和安全性;--有必要在更多生物模型上进一步研究已证明有效的方法;--考虑到 Beta 试验的纯度,开发的材料必须在临床研究中进行测试;--软骨细胞和细胞工程技术的使用使制作安全有效的假体以消除先天性耳廓闭锁成为可能。
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