Adhesives for medical application - Peel strength testing and evaluation of biophysical skin response

Abstract

BackgroundMedical adhesives are commonly used for securing wound dressings and medical devices used for diagnostic or therapeutic purposes. Mechanical irritation of skin due to adhesive stripping and repeated application can lead to discomfort and device removal. This study aims to examine the peel strength and skin response to different medical adhesives in a cohort of healthy volunteers. MethodTwelve healthy participants were recruited for peel strength testing of three candidate adhesive tapes, and evaluation of the skin response after adhesive removal. A modified ASTM D903 peel strength testing was performed at 180° peeling angle and a rate of 300 mm/min on the forehead, upper back and forearm skin. A longitudinal study was conducted on the forearm and back, with the adhesive samples left in-situ for up to 60 h for analysis of repeat application. The effects of two skin preparation approaches (water and alcohol cleaning) prior to adhesive application were also assessed. Skin biophysical properties were assessed at baseline and at various timepoints following adhesive removal using transepidermal water loss (TEWL), erythema and hydration. ResultsPeel strength reduced uniformly with repeat application over prolonged periods for all the adhesive samples tested. Skin preparation with water and alcohol cleansing prior to adhesive application increased peel strength at both the back (1.1% and 2.9%), and forearm (21.3% and 20%) sites. There was statistically significant increase from baseline to post-tape application for TEWL, skin redness and hydration (p < 0.001). However, there were no statistically significant differences between adhesive types (TEWL: p = 0.38, SR: p = 0.53, HY: p = 0.46). TEWL increased the most post-adhesion across all test sites and adhesive samples with repeat application (p < 0.05). Two-way ANOVA tests revealed no statistically significant interactions between the effects of application duration and adhesive on skin redness or TEWL for both the back and forearm sites (p > 0.05), though a significant interaction was indicted for hydration at the back site (p = 0.01). ConclusionThis study revealed that site and duration of adhesive application effected peel strength. The corresponding changes in skin properties identified that skin barrier function was disrupted with long-term application of adhesives. The back site was identified to be most reliable for adhesion testing and skin response assessment for future work.