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BACKGROUND: Typical uses of barrier films include protection from peri-wound maceration, ostomy appliance leakage, drainage from catheters/indwelling tubes, and exposure to incontinence. A new test model was developed to assess durability of barrier films. The model is based on the principle that efficacious barrier films provide a physical barrier between the skin and the external environment. If this is true, the barrier should prevent wash-off and wear-off of a harmless inert marker substance. Activated carbon powder (ACP) is one such marker. ACP is used extensively in cosmetic cleanser trials because it mimics dirt by getting into skin pores and creases, forming a highly visible, chemically inert stain.
METHODS: Barrier performance was assessed by randomly applying four barrier films over uniformly made ACP stains on the backs of 18 healthy adult subjects, and measuring intensity of those stains over a three-day wear period. Subjects were asked to shower once per day and avoid excessive physical activity or prolonged water exposure. On a daily basis, standardized digital photographs were taken of the test sites and used to monitor stain intensities with computer-assisted image analysis. Initial stain intensities after application of the barrier films were used as controls, and stain intensities at each day of the study were compared to the initial stains for residual stain intensity.
RESULTS: At all time points post-application, significant differences were detected among the four barrier films (p≤0.0001, alpha-adjusted Dunnett’s test). Interestingly, two of the films provided little protection at 24 hours post-application, while the two other films did provide significant protection even 72 hours post-application, but to different degrees.
CONCLUSIONS: These results indicate that health care professionals should request documentation of clinical efficacy of barrier films prior to product selection.