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

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

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

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Bibliographic Details
Published in:Acta Cirúrgica Brasileira Vol. 39; p. e396724
Main Authors: Silva, Chenia Frutuoso, Felzemburgh, Victor de Araújo, Moreno, Amanda Dourado, Meneses, José Valber Lima, Barbosa Júnior, Aryon de Almeida, Barreto, Isabela Cerqueira, Miguel, Fúlvio Borges
Format: Journal Article
Language:English
Published: Brazil Sociedade Brasileira para o Desenvolvimento da Pesquisa em Cirurgia 01-01-2024
Subjects:
Animals
Biocompatible Materials
Breast Implants
Male
Materials Testing
Models, Animal
Models, Theoretical
Original
Rats
Rats, Wistar
Silicone Gels
Silicones
Time Factors
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Summary:To describe an experimental surgical model in rats using a dual-plane technique for evaluation of biomaterials in an in-vivo silicone implant coverage. 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. 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. The experimental model described in this study proved to be suitable for evaluating the biomaterial used in the coverage of breast silicone implants.
Bibliography:Section editor: Eiji Kobayashi https://orcid.org/0000-0001-7038-7931
Conflict of interest: Nothing to declare.
ISSN:0102-8650
1678-2674
DOI:10.1590/acb396724