COPPER: A Trial Evaluating Copper-based Products for Incontinence-associated Dermatitis

This study adopts an exploratory trial design with an adaptive approach. It is randomized, multicenter, controlled, and double-blinded, with parallel groups and blinded outcome adjudication. The study hypothesis suggests that incontinence products infused with copper-based substances may provide superior stabilization of IAD compared to control products. The primary objective of the study is to evaluate the effectiveness of absorbing incontinence products containing a copper-based substance in stabilizing incontinence-associated dermatitis (IAD) in adults with moderate to severe urinary and/or fecal incontinence. This will be compared against standard absorbing incontinence products without copper-based substances, with both groups receiving usual care. Secondary objectives include assessing improvements in pain within 14 and 28 days, evaluating quality of life improvements over 28 days, and measuring changes in skin health scores from baseline to 14 and 28 days. Participants will be adults aged 60 years or older, experiencing moderate to severe urinary and/or fecal incontinence. Eligibility will be determined using specific scales outlined in the study rationale. Recruitment will target individuals in long-term care facilities or hospital wards located within São Paulo municipality and its metropolitan area in Brazil. Feasibility assessments will be conducted at each site during an initial visit. Sites deemed suitable will then proceed with participant recruitment. This study seeks to address critical aspects of managing IAD, particularly through innovative copper-based products. By focusing on clinical endpoints such as pain reduction, quality of life enhancements, and improvements in skin health, the trial aims to provide evidence supporting the potential benefits of copper-infused incontinence products over traditional alternatives.