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新型自粘性补片LifeMesh™在Sprague-Dawley大鼠中的生物降解性和安全性研究

Biodegradability and Safety Study of LifeMesh™, a Novel Self-adhesive Mesh, in Sprague-Dawley Rats.

作者信息

Ramot Yuval, Kronfeld Noam, Steiner Michal, Klaiman Guy, Hadid Amir, Sudak Michal, Nyska Abraham

机构信息

1 Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.

2 Envigo CRS (Israel) Ltd., Ness Ziona, Israel.

出版信息

Toxicol Pathol. 2019 Jun;47(4):483-493. doi: 10.1177/0192623319833906. Epub 2019 Mar 21.

Abstract

Self-adhesive meshes are being developed to avoid complications due to traumatic fixation methods. LifeMesh™ is a novel self-adhesive mesh with a biodegradable gelatin adhesive layer developed for hernia repair. The aim of this study was to assess the safety and biodegradability of LifeMesh in Sprague-Dawley (SD) rats for 6 weeks, in comparison to a bare polypropylene (BPP) mesh fixed with sutures. LifeMesh was tolerated well and its implantation did not result in any adverse local reaction, and its adhesive layer was substantially degraded after 4 weeks. Histopathological examination revealed that the presence of the adhesive contributed to a uniform thickness of the granulation tissue surrounding the mesh, in contrast to a nonuniform granulation tissue with BPP. Nonuniform granulation tissue suggests that there will be poorer integration of the mesh to the abdominal wall. The use of LifeMesh also resulted in less adhesions of internal organs with a smaller surface area of involvement. These findings lend support to the potential benefit of LifeMesh for hernia repair in humans and expand the available information on the typical histopathological findings expected with biodegradable implants in the peritoneal cavity of SD rats.

摘要

正在研发自粘式补片以避免因创伤性固定方法导致的并发症。LifeMesh™是一种新型自粘式补片,带有用于疝修补的可生物降解明胶粘合剂层。本研究的目的是与用缝线固定的裸聚丙烯(BPP)补片相比,评估LifeMesh在Sprague-Dawley(SD)大鼠体内6周的安全性和生物降解性。LifeMesh耐受性良好,其植入未导致任何不良局部反应,且其粘合剂层在4周后基本降解。组织病理学检查显示,与BPP导致的不均匀肉芽组织相比,粘合剂的存在使补片周围肉芽组织厚度均匀。不均匀的肉芽组织表明补片与腹壁的整合较差。使用LifeMesh还减少了内部器官的粘连,受累表面积更小。这些发现支持了LifeMesh对人类疝修补的潜在益处,并扩展了关于SD大鼠腹腔内可生物降解植入物预期典型组织病理学发现的现有信息。

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