Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage

Liquid stool and diarrhea are associated with an increased risk for moisture-associated skin damage (MASD), and clinical evidence suggests that exposure to liquid stool is associated with severe MASD and extensive erosion of affected skin. There are no known products on the market that treat fecal incontinence or MASD caused by fecal enzyme activity. Scotiaderm has invented a novel barrier cream (Dermategrity "Anti-fecal" Barrier Cream) with an enhanced formula containing zinc oxide and a natural plant extract that inhibits fecal enzymes to protect the skin while preventing further breakdown. Dermategrity "Anti-fecal" Barrier Cream has shown superior outcomes in comparison to zinc oxide alone in simulated laboratory testing, and promising results have been obtained in clinical case studies. To date, however, there has been no formal clinical testing of this new barrier product in comparison to standard zinc oxide creams. The purpose of this study is to perform a randomized, controlled clinical study comparing Dermategrity "Anti-fecal" Barrier Cream to zinc oxide barrier cream to determine if there is a difference in healing, clinical outcomes, and the speed of resolution of MASD symptoms between groups.

Patients who meet all the below criteria will be eligible for inclusion in the study: * ≥18 years of age; * Clinical diagnosis of incontinence-associated dermatitis resulting from diarrhea and/or fecal incontinence; * Minimum expected stay in hospital of two weeks; * Able to provide written informed consent (OR consent by a recognized substitute-decision maker) including explicit consent to take daily photographs of the rash associated with MASD. Patients who meet any of the following exclusion criteria will not be eligible for enrolment: * History of complex skin disorders (such as psoriasis or eczema); * Allergy to any of the ingredients in the study product; * Visual evidence of a bacterial skin infection; * Anticipated length of stay in hospital less than two weeks; * Life expectancy less than two weeks; * Use of a dressing or bandage covering the rash that cannot reasonably be removed for required study activities without compromising patient comfort or care. Note: Patients who are pregnant will not be excluded from the study unless they present with a rash or other skin conditions that may confound assessments.