Efficacy of gel containing organic extra virgin olive oil for peristomal skin hygiene: A pilot randomised controlled trial.

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.