Evaluation of a one-piece soft convex ostomy appliance: a prospective, multicentre, open-label pilot study

Abstract : Leakage of stomal effluent is considered by people living with a stoma to be the key factor that negatively impacts their quality of life (QoL). This non-randomised pilot study evaluated the performance of a new stoma appliance, Flexima® Active O Convex in 40 ostomy patients with a flat, flush or slightly retracted stoma over a 14-day period. Leakage was reported for the wear time of each pouch by the patients. On 79% of occasions, the patient reported no leakage under the skin protector. The appliance was very well tolerated and the condition of the patients' peristomal skin was maintained throughout the study. The performance was rated as ‘good’ or ‘very good’ by most of the patients. The results of this study have shown that the design of this one-piece soft convex appliance can prevent leakage and protect peristomal skin by providing a safe seal around the stoma. It was also reported as being flexible and comfortable to wear.