Measurement of Convexity Characteristics: A Transdisciplinary Consensus Conference

Abstract

While convex skin barriers have been used in patient care for decades, regulatory bodies and manufacturers have not established consistent parameters for measuring the most essential characteristics of a convex skin barrier. A transdisciplinary panel of manufacturers, engineers, marketing specialists and clinical subject matter experts from the United States was convened to address this gap. An initial consensus meeting was held to establish consensus around measurement parameters for 5 characteristics of convex skin barriers: depth, slope, flexibility, compressibility, and tension location. Consensus around 3 characteristics (depth, slope, and tension location) was achieved. In contrast, while multiple possible techniques for establishing measurement parameters for the remaining 2 characteristics (flexibility and compressibility) were discussed, final consensus for standardized measurement parameters was not achieved. The proceedings of this initial and novel approach to achieving consensus on measurement parameters for essential convexity characteristics lay the groundwork for development of international clinical practice standards on convex ostomy products. These standards aim to ensure predictable outcomes for persons with ostomies who use these products.