Abstract
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.
Highlights
A wound can be defined as damage to or an interruption of the normal anatomical structure of the skin, following a physical or thermal trauma or as a consequence of underlying medical or pathophysiological conditions
The wound healing process is generally influenced by several factors that can be divided into intrinsic and extrinsic and the combination of these factors is crucial for the repair of injuries [5]
The safety and effectiveness of the device should be demonstrated. These data, together with those deriving from the scientific literature, the results of the pre-clinical tests, the data design and the specific technical documentation should be included in the clinical evaluation report (CER) that the manufacturer will submit to a Notified Body
Summary
A wound can be defined as damage to or an interruption of the normal anatomical structure of the skin, following a physical or thermal trauma or as a consequence of underlying medical or pathophysiological conditions. Many options are available to treat these types of lesions from conventional and advanced dressings, implants, up to skin grafts, none of these are generally recognized as a gold standard In this context, the need for effective therapies, capable of reducing the time of wound closure and to improve the quality of life of the patients, emerges. Among the various advanced systems, medical devices (MDs) based on nanotechnologies have aroused interest, currently, there are only a few products in the pharmaceutical market These boast considerable advantages over the use of conventional medications, representing concrete options to efficiently manage non healing wounds, primarily generating health benefits for the patients and secondly economic advantages for healthcare systems. The discussion will be Pharmaceutics 2020, 12, 815 focused on the definition of critical quality attributes, MDs preclinical and clinical evaluation and the CE marking
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