Eliana Guerra

Background/Objectives: Peristomal skin complications (PSCs) are common among patients with ostomies, significantly impacting quality of life and increasing healthcare utilization. This study aimed to evaluate the effects of the Dermamecum protocol, a risk-stratified educational intervention, on the prevention of PSCs, self-care improvements, health-related quality of life (HRQoL), and patient satisfaction over a 90-day follow-up period. Methods: This prospective cohort study included 305 patients stratified into three risk-based groups (green, yellow, and red paths) according to the Dermamecum protocol. Primary outcomes included PSC rates at 30, 60, and 90 days. Secondary outcomes included self-care scores, HRQoL, and patient satisfaction. Comparative analyses and trend assessments were performed across groups and time points. Temporal trends in PSCs were analyzed using Poisson regression. Results: Early PSC rates were 8.5% at 30 days, with late complications at 7.9% and 6.2% at 60 and 90 days, respectively. No significant differences in PSC rates were observed between paths. Self-care scores improved over time, with stability across groups and domains. HRQoL remained stable, with minor fluctuations in physical and mental components. Patient satisfaction was high across all paths. Poisson regression identified significant temporal trends in PSC rates, with higher risks at 30, 60, and 90 days compared to baseline. Age, BMI, and path assignment (lower risk for the green path) were significant predictors of PSCs. Conclusions: The Dermamecum protocol effectively maintained low PSC rates, supported self-care, and sustained HRQoL and patient satisfaction. These findings highlight the value of risk-stratified, patient-centered interventions in ostomy care. Further studies are needed to validate these results and explore long-term outcomes.

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.