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

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.

Preliminary studies on the relationship among peel force, quantitative measures of skin damage and subjective discomfort.

Background/aims: The ability to anticipate skin damage and subject/patient discomfort due to the removal of adhesive materials without human testing is currently limited. While standardized laboratory methods have been developed, their ability to model and predict the interaction with relevant living substrate is imperfect. The aim of this study was to assess the adhesion of various materials as a function of time using the abdomen as the body site, and determine if a relationship existed with skin damage and subject discomfort.

Validity and reliability of a pad test model using a simulated urine leak and healthy continent females.

The objective of this study was to determine the validity and reliability of a modified pad test to assess urinary incontinence. Urine leakage was simulated using normal saline that was dosed onto super-absorbent incontinence pads, and worn by healthy continent females over two sequential 12-hour time periods. The results indicate that the two x 12-hour pad test provides a reliable assessment of urine leak in female subjects.