Abstract
To date fundamental knowledge is lacking regarding anatomical and physiological characteristics of the skin and skin thickness in children aged 0 to 18 years. Which results in the absence of applicable devices for accurate intradermal injections in this population. This doctoral MedTech research project aims to gather the anatomical and physiological characteristics of children and adolescents aged 0 to 18 years.
First research will be done to gather anatomical and physiological characteristics of the skin of children and adolescents (WP 1). High-Frequency Ultrasound will be used to visualise the skin of children and measure thickness of the two outer skin layers. Both forearm and deltoid region will be evaluated as possible injection sites. Secondly the needle parameters will be investigated in an animal model (WP 2). Three species will be incorporated: mice, rats and piglets. Third, device prototypes will be tested in living piglets to evaluate for injection depth and distribution of the injected fluid. Lastly prototypes will be part of a clinical trial with vaccine antigen in children to evaluate for acceptability (pain perception and safety aspect) and immunogenicity.
With this research, Novosanis, aims to development of a new device platform for intradermal injection.
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