A computer-assisted in-vitro biomaterial test for percutaneous devices using human keratinocyte cultures.

The aim of this study was to assess the suitability of a computer-assisted in vitro test system to evaluate candidate biomaterials used for percutaneous devices. Silicone rubber (Silastic) and five different polymers from the Eurobiomat concerted action, polyetherurethane, polyvinylchloride with plasticizer, di-ethylhexylphthalate (PVC-DEHP), polyvinylchloride with plasticizer, tri-ethylhexyltrimellitate (PVC-TEHTM), polyethylene and polypropylene were examined with respect to their qualities to facilitate keratinocyte attachment. HaCaT-cells, a spontaneously transformed non-tumorigenic human keratinocyte cell line, were cultured on the different materials for 3 days. Cellular behaviour was examined morphologically by phase-contrast and scanning electron microscopy throughout the 72 h incubation period. For the computer-assisted measurement of the cell-covered substrate surface and subsequent statistical analysis the cells were fixed after 3 days of incubation, stained, photographed and the images then digitally transformed. Of the different polymers examined silicone rubber showed the most favourable results with respect to the quantitative analysis of the cell-covered substrate surface as well as concerning cytomorphological findings. The results of this study indicate that the in vitro test system described is a sensitive screening method for evaluating candidate biomaterials used for percutaneous devices in a fast and reproducible manner, thus reducing number of animal experiments.