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EN
The new implemented wound dressings should meet several requirements connected with the clinical safety and performance. The series of PN-EN 13726 Standards describes the tests methods for the verification the most important parameters related to mentioned performance and safety of a new designed wound dressing being the base for the risk analysis (according to PN-EN ISO 14971:2009 Standard). The aim of the research was to evaluate the behavior of several types of new designed prototypes of innovative wound dressings made of various form of chitosan (such as: foams, films, etc.). The behavior of studied chitosan wound dressings was evaluated before and after of accelerated aging according to ASTM F 1980-07:2002 to establish the effect of the wound dressings storing conditions. The presented study is a continuation of earlier research.
EN
There is endless and growing demand on a novel and innovative wound dressings, which except basic protective performance accelerate the process of wounds healing and/or replace the patient skin function. The studies on the new wound dressings result from the need of the quick and effective treatment of wounds, such as: having no tendency to heal, posttraumatic wounds, scalding wounds, ulcerations or bedsores. Chitosan is a biopolymer originated from chitin by N-acetylation. Due to the special behavior, such as: biological activity, it is linked to polymers having several and multifunctional applications, especially for designing of medical devices. The aim of the research was to evaluate the comprehensive performance of several kinds of chitosan prototypes of innovative wound dressings made of various usable form of chitosan. The evaluation of mentioned prototypes of wound dressing was carried out using the guidelines from series of PN-EN 13726 Standards harmonized with UE Directive 93/42/EEC and 2007/47/WE for medical devices.
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EN
Recently, the market of medical devices shows serious need for wound dressings for first aid and temporary traumatic wounds. Such a wound dressing should show primarily the hemostatic effect and antibacterial activity allowing protection against infection. Tromboguard® topical wound dressing is a three-layer dressing with active layer. It contains chitosan, sodium alginate/calcium alginate with addition of silver salt. The wound dressing provides protective performance as well as is characterized by the ability to immediately stop bleeding and antibacterial activity allowing protection against infection and occurrence of secondary infection without the need for or with limited participation of antibiotics. Tromboguard® topical wound dressing is a firs aid dressing designed for the uniform services (military and homeland) and rescue.
EN
Investigations are presented in the preparation of a first aid haemostatic dressing that would exhibit an adequate haemostatic capacity in injuries and surgical wounds, an antibacterial activity to prevent primary and secondary infections, and offer safety in use
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