Abstract
This study, employing an interim analysis, investigates the effects of the Dermamecum protocol, a structured educational and tailored approach that stratifies ostomy patients into risk paths (green, yellow, red) based on pre-operative and post-operative characteristics. The green path indicates a low risk of peristomal skin complications (PSCs), focusing on sustaining healthy behaviours and basic stoma care. The yellow path represents a moderate risk, emphasizing the need for patients to self-monitor and recognize early signs of complications. The red path corresponds to high risk, requiring stringent monitoring and immediate access to healthcare support. The study aims to reduce PSCs and improve patient outcomes. Methods include the stratification of 226 patients, with significant differences in gender distribution, BMI categories, and stoma types across the paths. Results show an occurrence rate of PSCs of 5.9% in all risk paths (5.7% green path, 4.7% yellow path, and 7.9% red path, p = 0.685), significantly lower than the median rate of 35% reported in the literature. Multiple correspondence analysis validated the stratification, with distinct clusters for each path. Poisson regression models in the exploratory framework of an interim analysis identified male gender as the only significant predictor of PSCs, indicating the need for gender-specific interventions. The findings suggest that the Dermamecum protocol effectively reduces early PSCs, providing a foundation for further research.