A Concave Shaped Skin Barrier Provides Improved Clinical Outcomes for People Living With an Ostomy Who Have an Outward Peristomal Body Profile.

Purpose: The purpose of this study was to compare leakage rates, skin health, fit, patient impact and usability for a concave ostomy system versus the non-concave ostomy system subjects were using prior to the study.

Design: Single-arm, open-label, multicenter, prospective study with subjects acting as their own control.

Subjects and setting: The sample comprised 20 subjects recruited from 3 outpatient clinics in Quebec, Canada. All participants were adults with an ostomy and had an outward peristomal body profile (OPBP).

Methods: Data were collected by investigators during in-person visits. Skin health was assessed using the Ostomy Skin Tool. Patient-reported outcomes were collected at each visit using a questionnaire designed for this study. Investigator-reported observations were also collected using a study-specific questionnaire at each visit. Generalized linear mixed model analyses were used to analyze the data.

Results: Use of the concave skin barrier significantly reduced leakage occurrences, improved peristomal skin health, provided a better fit, enhanced the users' sense of security, comfort, and ease of application of the concave pouching system when compared to a flat or convex skin barrier.

Conclusions: The use of a concave ostomy system for patients with an OPBP significantly reduced leakage while improving skin health, fit, patient impact and usability.