Comparative Assessment of Skin Protectant Barrier Film Product Effectiveness Utilizing a Novel Approach that Combined Lucifer Yellow Dye Penetration and an ex vivo Porcine Skin Model of Urinary Incontinence

Introduction: A compromised epidermal barrier underlies incontinence-associated dermatitis (IAD). Skin protectant barrier film products can be applied to provide a robust, flexible, and long-lasting shield from caustic bodily fluids and friction from clothing, diapers, and wiping, all while maintaining moisture homeostasis and breathability. The goal of this study was to compare the effectiveness of two skin protectant barrier films: one containing neat cyanoacrylate polymer (NC)* and the other a solvent-containing polymer-cyanoacrylate (SC)°. We developed a novel method utilizing Lucifer Yellow (LY) dye, an aqueous solution normally retained by the stratum corneum of healthy, non-damaged epidermis, to evaluate barrier properties under simulated clinical conditions of urinary incontinence.Methods:Test sites (n= 3 per group) were marked on excised porcine skin and treated with or without skin protectant barrier film product. Sites were either unchallenged (controls) or exposed to one or four cycles of moisture challenge (15 minute incubation in simulated urine) and 500 wipes with a moist sponge using an Elcometer 1720 Washability & Abrasion Tester. LY was applied topically and incubated for one hour. Test sites were fixed, processed for frozen sectioning, and mounted using antifade mounting media with DAPI. Sections were viewed using confocal microscopy.Results:Following one challenge cycle, LY breached the stratum corneum and penetrated below the epidermis at multiple locations in all untreated sites and two out of three SC°-treated sites. Conversely, LY was retained by the stratum corneum in all NC*-treated samples. Following four challenge cycles, untreated and SC°-treated sites had areas of broken or missing epidermis and significant LY barrier breach, while two NC*-treated sites had LY-retained by the stratum corneum and only one minor area of LY penetration below the surface in one site. The NC*-treated samples retained a better skin barrier compared to SC°-treated sites.Discussion: References: