Background:

The security of an ostomy pouch is often compromised when peristomal skin folds are present, when the stoma is retracted or when there is an increased amount of liquid stool. Ostomy appliances with convexity improve the peristomal seal of a barrier.¹

Purpose:

To compare the performance of a new 2-piece drainable ostomy pouching system with convexity (system A) to an established system already known to the market (system B).

Methodology:

75 people with an ileostomy aged 55 ± 16 years (mean ± SD) participated in the study conducted in Germany at 14 home care centres.  Participants tested the new pouching system as well as the reference system.  Each participant evaluated one of the pouching systems for two weeks and the other system for another two weeks in randomized order. Investigators visited the participants three times during the study. Investigators filled in a questionnaire about baseline characteristics and user patterns and participants filled in one about product performance and safety. Statistics included: paired Wilcoxon, Sign and Students t-test; and Binomial test (a=0.05).

Results:

The adhesive on the baseplate was significantly more flexible, easier to remove and had a better adhesion during use and a better resistance to erosion (wearing away), p<0.01. The outlet on the new pouch was significantly easier to clean and more secure than the reference (p<0.0005). The coupling provided a significantly better reassurance, and significantly fewer participants were bothered about the pressure needed to apply the new pouch to the new barrier (p<0.01). The majority of participants (96%) preferred the new pouch system to the reference (p<0.0005).

Conclusion:

This study showed a significantly better performance of the new 2-piece drainable pouching system with convexity than with the reference pouching system on key parameters related to security of the barrier as well as the outlet and mechanical coupling.