Peristomal skin conditions and stoma appliances – clinical study results

Introduction: Peristomal skin disorders are common among people with a stoma¹. Healthy peristomal skin should be maintained by a combination of using appropriate ostomy appliances and help from a stoma care nurse. 

Objective: To measure changes in peristomal skin conditions in a real-life setting of people with a stoma, wearing an ostomy appliance with a double-layer adhesive.

Methods: This French study was part of a global open label, non-comparative, post-marketing study, the DialogueStudy, scheduled for involving more than 500 stoma care nurses from more than 15 countries. The DialogueStudy evaluated how an appliance with a double-layer adhesive worked in a real-life setting, with the focus of measuring quality of life and peristomal skin conditions. The participants wore the appliance for 6-8 weeks, and data were collected in a questionnaire at study start and end. Peristomal skin conditions were measured on a scale from 0 (healthy skin conditions) to 15 (worst skin conditions) – the Discolouration, Erosion and Tissue Overgrowth (DET) score, measured by the Ostomy Skin Tool². Statistics: Linear mixed models and logistic regression will be used for analyzing the data.

Results: In total, 524 people with a stoma will be included. The study will be completed during November 2009. The relationship between peristomal skin conditions (DET scores) and leakage frequency at baseline will be investigated. DET scores for people with a colostomy and people with an ileostomy will be presented and changes in DET scores during the study will be evaluated. The appliances used before entering the study and during the study will be evaluated with respect to: leakage, unexpected changes, adhesion, security, adhesive erosion and absorption, pain at removal, bad odour, comfort, ballooning, handling of outlet.