Randomized crossover comparison of adhesively coupled colostomy pouching systems

Ostomy pouching systems affect well being and quality of life, making selection of the appropriate system a key element of ostomy care. Several innovative adhesively coupled, two-piece systems are on the market. They feature flexible low profiles, allowing pouch removal/replacement without changing the skin barrier or wafer. This facilitates inspection or pouch changes without disrupting peristomal skin. Because few controlled trials compare pouching system effectiveness, a prospective, randomized open-label, crossover study was conducted. Under the supervision of ostomy care nurses in six outpatient clinics in Germany, clinical performance of and patient preferences for two adhesively coupled, closed-end pouching systems were compared during normal use. One is a gelatin/pectin-based skin barrier sealed to the pouch with a company-specific adhesive coupling technology (System E); the other, a grooved base plate wafer adhesive pouch coupling system (System F). Seventeen attributes and seven end-of-study measures that included comfort, flexibility, wear time, ease of removal, and overall performance were assessed. Informed, consenting participants were randomly assigned to use one system for five skin barrier/wafer changes or up to 15 days and subsequently switched to the alternative system for a similar period. The 39 participants used a total of 1,645 pouches and 342 skin barriers. All were found safe as determined by incidence and nature of the reported peristomal skin problems, subject withdrawals, and adverse events for both systems. However, System E provided longer pouch wear times (P < 0.01). End-phase ratings favored System E on 10 of the 17 attributes (P < 0.04) and System Fon none. More participants preferred System E on all seven end-of-study measures, five significantly (comfort, flexibility, wear time, ease of removal, and overall performance; (P < 0.02). These participant-reported, ostomy-related outcomes underscore the importance of product evaluation and selection for persons with an ostomy.