This review summarizes published literature on in-vitro and ex-vivo test methods for pre-clinical evaluation of wound care products. There is currently no guidance from e.g. authorities on how wound care products, especially antimicrobial wound care products, should be assessed regarding their cell toxic effects and their antimicrobial performance. Even though ISO 10993-1 gives clear guidance for biocompatibility evaluation of medical devices, the corresponding methods do not reflect wound conditions. Regarding antimicrobial efficacy the first standard EN 17854 for wound dressings was published recently. For all other endpoints no standards are available. In addition, there are increased ethical considerations that animal testing should be avoided. This was first practiced in cosmetic industry and is now implemented presenting a central part of ISO 10993-1 for toxicity assessment of medical devices. At the same time, there is increasing evidence that in-vitro and ex-vivo methods can replace animal testing for certain endpoints with the advantage that a partially difficult transfer of data from animals to humans may not be needed anymore. This review presents a comprehensive overview of methods that can be used for pre-clinical evaluation of wound care products.
Schuhladen et al. (Wed,) studied this question.