ABSTRACT
AIM: To assess the efficacy and safety of the application, during stoma hygiene, of a pH-neutral gel containing organic EVOO (oEVOO) for the maintenance of peristomal skin integrity. METHOD: Patients with a colostomy or ileostomy were enrolled in a pilot randomized controlled trial and assigned treatment with a pH-neutral gel made from natural products including oEVOO or usual stoma hygiene gel. The primary outcome was three domains of abnormal peristomal skin: Discolouration, Erosion and Tissue overgrowth. Secondary outcomes that were evaluated included skin moisture; oiliness; skin elasticity; water-oil balance; patients' perceptions; difficulty inserting and removing the pouching system; pain, any other chemical, infectious, mechanical, or immunological complications of concern. The intervention lasted 8 weeks. RESULTS: Twenty-one patients were recruited for the trial and randomly assigned to either the experimental group (n = 12) or the control group (n = 9). The groups did not differ significantly in terms of patient characteristics. No significant differences between groups were identified either at baseline (p = 0.203) or at the end of the intervention (p = 0.397). In the experimental group, domains of abnormal peristomal skin improved after the intervention. The difference observed before and after the intervention was statistically significant (p = 0.031). CONCLUSION: The use of a gel containing oEVOO has shown similar levels of efficacy and safety to other gels commonly used for peristomal skin hygiene. It is also relevant to highlight that a significant improvement in skin condition was observed in the experimental group before and after the intervention.
