Evaluation of a New Advanced Barrier Film to prevent skin irritation in a guinea pig model

A guinea pig model was used to test a new barrier film being designed for patients at risk for incontinence-associated dermatitis or general loss of skin integrity. The objective of this study was to evaluate the barrier efficacy of a new product in protecting intact skin from irritation due to a caustic irritant. The test method used hairless guinea pigs and a simulated incontinence exposure. Six 1.5 by 1.5 inch sites on each back (intact skin) were marked. Five were treated with the new barrier and one left untreated as a control. The treatment was allowed 5 minutes to dry. All sites were then challenged with a solution of pancreatin in alkaline solution (pH 9) using an occlusive patch test system, covered with a custom-cut transparent film dressing, and followed for 48 hours. At 48 hours, the skin irritation of each site was scored. The amount of irritation was measured as a percentage of the 25 mm round area of challenge given by the occlusive chamber. The level of irritation was given a score of 1-4 based on the Clinician Erythema Assessment scale¹. All the sites were given a score by multiplying the level of irritation by the percent irritation to provide a normalized irritation score. The scores were compared using an analysis of variance (ANOVA) with Guinea pig as a random effect and formula (new barrier or untreated) as a fixed factor in the model. The average normalized irritation score was 0.2 for the new barrier and 1.7 for the control (p<0.001). The untreated sites had therefore 8.5 times more irritation than sites covered with the new barrier film. This experiment demonstrated that a single application of the new barrier can prevent skin breakdown from a caustic irritant and provide protection for at least 48 hours in this model.