Outcomes of a Risk-Stratified Protocol for Preventing Peristomal Skin Complications in Patients with an Ostomy: A Cohort Study.

Abstract

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.