Chronic wounds, such as pressure ulcers, diabetic ulcers, venous ulcers and arterial insufficiency ulcers, are lesions that fail to proceed through the normal healing process within a period of 12 weeks. The treatment of skin chronic wounds still represents a great challenge. Wound medical devices (MDs) range from conventional and advanced dressings, up to skin grafts, but none of these are generally recognized as a gold standard. Based on recent developments, this paper reviews nanotechnology-based medical devices intended as skin substitutes. In particular, nanofibrous scaffolds are promising platforms for wound healing, especially due to their similarity to the extracellular matrix (ECM) and their capability to promote cell adhesion and proliferation, and to restore skin integrity, when grafted into the wound site. Nanotechnology-based scaffolds are emphasized here. The discussion will be focused on the definition of critical quality attributes (chemical and physical characterization, stability, particle size, surface properties, release of nanoparticles from MDs, sterility and apyrogenicity), the preclinical evaluation (biocompatibility testing, alternative in vitro tests for irritation and sensitization, wound healing test and animal wound models), the clinical evaluation and the CE (European Conformity) marking of nanotechnology-based MDs.

译文

慢性伤口,例如压疮,糖尿病性溃疡,静脉性溃疡和动脉功能不全溃疡,是在12周内无法进行正常愈合过程的病变。皮肤慢性伤口的治疗仍然是一个巨大的挑战。伤口医疗设备 (MDs) 的范围从常规和高级敷料到皮肤移植物,但这些都不是公认的金标准。基于最近的发展,本文回顾了基于纳米技术的用于皮肤替代品的医疗设备。特别地,纳米纤维支架是用于伤口愈合的有希望的平台,特别是由于它们与细胞外基质 (ECM) 的相似性以及当移植到伤口部位时促进细胞粘附和增殖以及恢复皮肤完整性的能力。这里强调了基于纳米技术的支架。讨论将集中在关键质量属性的定义 (化学和物理表征,稳定性,粒度,表面特性,纳米颗粒从MDs的释放,无菌性和无菌性),临床前评估 (生物相容性测试,刺激和敏化的替代体外测试,伤口愈合测试和动物伤口模型),基于纳米技术的MDs的临床评估和CE (欧洲一致性) 标记。

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