Leakage and ostomy appliances: results from a large-scale, open-label study in clinical practice

Abstract

Leakage from an ostomy appliance impairs peristomal skin integrity and quality of life (QoL). The proportion of participants who reported that they ‘never’ had leakage increased from 13% at visit 1 (i.e. with their pre-study appliance) to 36% at visit 2 (i.e. after using the double-layer adhesive appliance, SenSura (Coloplast A/S)) (P<0.0001). The proportion of participants reporting that they ‘never’ had unplanned changes increased from 12% at Visit 1 to 34% at visit 2 (P<0.0001). The double-layer adhesive appliance, SenSura, in conjunction with advice/intervention from a stoma care nurse (SCN), was superior to the pre-study appliance across all performance parameters (P<0.0001), including adhesion, flexibility and erosion. Higher leakage frequency at baseline correlated with worse peristomal skin (P<0.0001). Peristomal skin improved from visit 1 to visit 2, across all leakage frequencies. The use of an appropriate double-layer adhesive appliance in conjunction with SCN intervention, reduced leakage and improved peristomal skin conditions.