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.

Human Colon-on-a-Chip Enables Continuous In Vitro Analysis of Colon Mucus Layer Accumulation and Physiology.

BACKGROUND & AIMS: The mucus layer in the human colon protects against commensal bacteria and pathogens, and defects in its unique bilayered structure contribute to intestinal disorders, such as ulcerative colitis. However, our understanding of colon physiology is limited by the lack of in vitro models that replicate human colonic mucus layer structure and function. Here, we investigated if combining organ-on-a-chip and organoid technologies can be leveraged to develop a human-relevant in vitro model of colon mucus physiology. METHODS: A human colon-on-a-chip (Colon Chip) microfluidic device lined by primary patient-derived colonic epithelial cells was used to recapitulate mucus bilayer formation, and to visualize mucus accumulation in living cultures noninvasively. RESULTS: The Colon Chip supports spontaneous goblet cell differentiation and accumulation of a mucus bilayer with impenetrable and penetrable layers, and a thickness similar to that observed in the human colon, while maintaining a subpopulation of proliferative epithelial cells. Live imaging of the mucus layer formation on-chip showed that stimulation of the colonic epithelium with prostaglandin E2, which is increased during inflammation, causes rapid mucus volume expansion via an Na-K-Cl cotransporter 1 ion channel-dependent increase in its hydration state, but no increase in de novo mucus secretion. CONCLUSIONS: This study shows the production of colonic mucus with a physiologically relevant bilayer structure in vitro, which can be analyzed in real time noninvasively. The Colon Chip may offer a new preclinical tool to analyze the role of mucus in human intestinal homeostasis as well as diseases, such as ulcerative colitis and cancer.