Background: A suitable appliance to collect stoma output is essential to ease everyday life as much as possible for people with a stoma. Ostomy appliances with adhesive couplings provide a more flexible and discrete alternative to appliances with mechanical couplings that are being widely used. Adhesive couplings have been developed to offer the same security as mechanical couplings.

Purpose: To compare the performance and safety of a new 2-piece ostomy appliance with an adhesive coupling to that of an established 2-piece ostomy appliance with an adhesive coupling.

Methodology: The study was a randomised, open, crossover study that was ongoing in France and includes 15 investigational centres. Forty-six participants with a colostomy that normally wear a two-piece appliance with a mechanical coupling were included. Each participant tested two kinds of ostomy appliances in randomised order.  The participants tested 5 base plates each and the bags had to be changed in accordance with the participant's normal pattern of routine. The participants visited the investigators three times during the study: At start up; after testing the first kind of ostomy bag; and after testing the second kind of ostomy bag (termination).  The investigator had to fill in a questionnaire during the 3 visits covering base line characteristics, user patterns and skin evaluations. The participant had to fill in another questionnaire while testing the appliances covering bag performance and safety. The statistical analyses will be performed with SAS statistical software package, version 9.1 (SAS Institute Inc., Cary, NC). The data will be analysed with the following methods: Ordinal logistic regression (Proportional odds), Logistic regression, Analysis of variance, McNemar test, Binomial test, and Paired t-test.

Results: The data processing will be finalised late November 2007. Results on performance and safety of the two appliances will be presented.