Novel instrumentation to determine peel force in vivo and preliminary studies with adhesive skin barriers.

ABSTRACT

BACKGROUND/PURPOSE: Adhesive barriers secure medical devices to skin. Laboratory adhesion models are not predictive of in vivo performance. The objectives of these studies were to validate a novel peel force device, and to investigate relationships between barrier formulations, barrier width, subjective discomfort during barrier removal, and substrates. METHODS: Three hydrocolloid barrier formulations in three widths were adhered to ethylene/methyl acrylate film (EMA), VITRO-SKIN(®) and human abdominal skin. Peel force was measured using a MTS Insight™ and a cyberDERM Inc. Mini Peel Tester (CMPT). Subjects reported their discomfort. RESULTS: Peel forces were highly correlated between devices and highly dependent on substrate. Data suggested a weak direct association between peel force in vivo and discomfort. The 0.5″-wide barriers had the most precise peel forces measurements in vivo. A weak negative relationship between normalized peel force and barrier width on human skin was found. There was a strong positive relationship between peel force in vivo and on EMA, whereas no correlation was observed with VITRO-SKIN(®). CONCLUSION: The CMPT correlates with a standard instrument and can advantageously investigate adhesion in vivo. Barrier width and substrate impact the reliability and predictability of peel force measurements.