Experimental protocol for evaluation of biomaterials in an in-vivo silicone implant coverage.

Acta cirurgica brasileira Pub Date : 2024-09-30 eCollection Date: 2024-01-01 DOI:10.1590/acb396724
Chenia Frutuoso Silva, Victor de Araújo Felzemburgh, Amanda Dourado Moreno, José Valber Lima Meneses, Aryon de Almeida Barbosa Júnior, Isabela Cerqueira Barreto, Fúlvio Borges Miguel
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Abstract

Purpose: To describe an experimental surgical model in rats using a dual-plane technique for evaluation of biomaterials in an in-vivo silicone implant coverage.

Methods: This study was developed following the ISO 10993-6 standard. In this study, 40 male Wistar rats weighing between 250 and 350 g were used, distributed into two groups: experimental, biomaterial superimposed on the minimammary prosthesis (MP); and control, MP without implantation of the biomaterial, with eight animals at each biological point: 1, 2, 4, 12, and 26 weeks. Thus, at the end of biological points (1, 2, 4, 12, and 26 weeks; n = 8 animals per week), the tissue specimens achieved were fixed in buffered formalin and stained with hematoxylin-eosin.

Results: Macroscopically, throughout the study, no postoperative complications were apparent. In the histological analysis, it was possible to observe the evolution of the inflammatory response, tissue repair, and fibrous capsule during the biological points.

Conclusions: The experimental model described in this study proved to be suitable for evaluating the biomaterial used in the coverage of breast silicone implants.

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在体内硅胶植入物覆盖中评估生物材料的实验方案。
目的:描述一种使用双平面技术的大鼠实验性手术模型,用于评估体内硅胶植入物覆盖中的生物材料:这项研究是根据 ISO 10993-6 标准开发的。在这项研究中,使用了 40 只体重在 250 至 350 克之间的雄性 Wistar 大鼠,将其分为两组:实验组,在微乳假体(MP)上叠加生物材料;对照组,在微乳假体上不植入生物材料,每个生物点有 8 只动物:1、2、4、12 和 26 周。因此,在生物点(1、2、4、12 和 26 周;每周 n = 8 只动物)结束时,将获得的组织标本固定在缓冲福尔马林中,并用苏木精-伊红染色:结果:从宏观上看,在整个研究过程中没有发现明显的术后并发症。在组织学分析中,可以观察到生物点的炎症反应、组织修复和纤维囊的演变:本研究中描述的实验模型证明适用于评估用于覆盖乳房硅胶假体的生物材料。
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