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Optimized protocol for the biocompatibility testing of compression stockings and similar products with close skin contact in vitro

: Wiegand, Cornelia; Hansen, Tanja; Köhnlein, Johanna; Exner, Ines; Damisch-Pohl, Marlen; Schott, Peter; Krühner-Wiesenberger, Ulrike; Hipler, Uta-Christina; Pohlen, Ernst


Journal of the Textile Institute : JOTI 109 (2018), No.7, pp.891-902
ISSN: 0040-5000
ISSN: 1754-2340
Journal Article
Fraunhofer ITEM ()
biocompatibility; compression stocking; cytotoxicity; DIN EN ISO 10993-5; fibroblast; keratinocytes; cell line

Biocompatibility of six different compression stockings and cytotoxic effects were determined using HaCaT keratinocytes, L929 mouse fibroblasts, primary adult and juvenile keratinocytes Cells were quantified using a luminometric ATP assay and the photometric BCA test. Cytotoxic effects were determined by LDH release. An area-based extraction ratio of 1.25 cm2:mL could be shown to be superior to the weight-based extraction of test material. Extraction medium should be an acidic sweat solution as this helps to recreate in vivo conditions. Monolayer cultures of HaCaT keratinocytes or L929 mouse fibroblasts should be used for testing. Primary adult keratinocytes or primary juvenile keratinocytes can also be used. For the latter, testing under DMEM with FCS is recommended to achieve comparable results. It was found that the compression stockings tested exhibited no negative influence on cell viability in vitro and no direct cytotoxic effects measured as release of LDH. Henc e, good biocompatibility could be asserted.