Performance Evaluation of a Novel Ostomy Barrier Ring with Assisted Flow through a Single-Arm, Open-Labelled Feasibility Study.

PURPOSE: The purpose of this study was to evaluate a novel barrier ring that has a non-absorbent component with an assisted flow mechanism by assessing changes in skin condition and perceptions of comfort, security, handling, and discretion in persons with an ileostomy for 6 months or longer.

SUBJECTS AND SETTINGS: Twenty participants (aged ≥ 18 years) with an ileostomy for 6 months or more participated in a single-arm, open-labelled feasibility study.

METHODS: Participants used the barrier ring along with their normal pouching system for a period of 6 weeks. Changes in skin condition were assessed using the Ostomy Skin Tool (OST). Participants’ perception of comfort, security, handling, and discretion were recorded on a 10-point scale, where participants would offer a low score if their experience was negative and a higher score if their experience was positive. For participants who completed the study, the average skin condition and median ratings of comfort, security, handling, and discretion at 6 weeks were compared to baseline values.

RESULTS: Twelve of the 20 participants (60%) completed the study. The primary reason for dropouts concerned compatibility issues between the barrier ring and certain convex pouching systems. For those who completed, the mean score on the OST decreased from 6.2 ± 1.90 (mean ± SD) at baseline to 3.4 ± 1.73 at 6 weeks, indicating a mean reduction of 2.8 (95% CI, − 1.6 to − 3.9; P < .001). The peristomal skin condition of 9 participants improved, whereas 3 experienced no change. All participants who completed the study rated comfort, handling, security, and discretion highly (median score 10 at baseline and at 6 weeks).

CONCLUSIONS: Study findings indicate the novel ostomy barrier ring may reduce peristomal skin complications in persons living with an ileostomy, though a more extensive trial is recommended.