Evaluation of a Skin Barrier Ring with Assisted Flow: A Prospective Cohort Study

PURPOSE: The purpose of this study was to assess the effect of a skin barrier ring with assisted flow in preventing peristomal skin complications (PSCs) in patients with an ileostomy and to evaluate the participants' perceptions of the device. DESIGN: Single-group, prospective cohort study. SUBJECTS AND SETTING: Both inpatients and outpatients with newly created (n = 14) or established (n = 1) ileostomies were recruited from 2 clinical sites in the United States: one was an academic teaching hospital system in the Midwestern United States and the second was a teaching hospital located in the Southeastern United States. METHODS: Participants used the skin barrier ring with assisted flow after receiving education on its use. The pouching system was changed on a routine basis as determined by the ostomy nurse specialist. The Ostomy Skin Tool (OST) was used to assess each participant's peristomal discoloration (D), erosion (E), and tissue overgrowth (T) on admission to the study (baseline) and at final assessment (60 ± 33 days). Secondary outcomes (device handling, comfort, and discretion) were assessed through a questionnaire administered during the final data collection visit. RESULTS: The mean baseline DET score among the 14 participants with a new ileostomy was 2 or less, indicating no PSCs. The incidence of PSCs in this study was 40% (n = 6). Thirteen of 15 participants (86.7%) agreed that the skin barrier ring with assisted flow was easy to apply. Fourteen (93.4%) agreed that the device was comfortable and easy to remove. All 15 participants (100%) agreed it was discreet under clothing. CONCLUSIONS: Sixty percent of participants (n = 9) using the investigational device experienced a PSC. More than 90% of participants agreed that the device was comfortable and easy to remove, and all participants (100%) agreed it was discreet when worn under clothing.