Abstract
PURPOSE: The purpose of this study was to evaluate skin condition and quality of life following the use of a double-layer adhesive pouching system. This article reports results from North American participants.
DESIGN: The study was an open-label, noncomparative, multicenter study.
SUBJECTS AND SETTING: Seven hundred forty-three persons with ostomies who reside in North America participated in the study.
INSTRUMENTS: A Stoma-Quality of Life (QOL) questionnaire consisting of 20 questions was used to measure health-related quality of life. The Ostomy Skin Tool was used to assess peristomal skin condition.
METHODS: Peristomal skin and health-related quality of life were assessed by WOC nurses at baseline and again after 6 to 8 weeks following the use of a double-layer adhesive ostomy pouching system. The participants recorded self-reported leakage level, presence of peristomal skin disorder, use of appliance type (eg, convex, 1- or 2-piece), and frequency of consultation with the WOC nurse.
RESULTS: Participants experienced a significant decrease in frequency of pouch leakage (P < .0001) and accessory use, improvement of skin condition, and overall significant improvement in mean quality of life score (56.8 vs 58.9, P < .0001). The greatest change on the Stoma-QOL scores was observed in the quartile of participants with the lowest QOL at baseline. Their QOL scores rose from a mean 43.8 at visit 1 to 50.1 at visit 2 (P < .0001).
CONCLUSION: The combination of a regular contact with a WOC nurse and the use of a double-layer adhesive appliance led to a significant reduction in leakage and accessory use, improved skin condition, and significant improvement in health-related quality of life.