A Single-arm, Practical Application Assessment of User Experience and Peristomal Skin Condition Among Persons With an Ileostomy Using a New Barrier Seal With Assisted Flow

Peristomal skin complications are a common problem for persons with an ileostomy.The purpose of this pilot study was to solicit user feedback and perform an initial assessment of the performance of a new barrier seal designed to decrease the risk of chemical-induced dermatitis.Seven (7) potential participants who were at least 18 years of age,6 months post surgery, with an end or loop ileostomy and unbroken peristomal skin, and who were capable of changing their appliance themselves or had the availability of care assistance were identified and recruited by the stoma care nurse at the University Hospital, Limerick, Ireland. At the initial visit and after 1 and 2 weeks, participants were asked to rate device comfort, security, and handling; skin condition was assessed by the research nurse using the Ostomy Skin Tool. Descriptive statistics were used to tabulate the results.Five (5) participants completed the study. Discoloration, erosion, and tissue overgrowth scores improved in 3 of 5 patients, and the mean Ostomy Skin Tool score decreased from 5.4 ± 2.19 at the initial assessment to 4 ± 1.87 at the week 2 visit. Comfort, handling, and security ratings increased from a median of 8 at the beginning of the study to 10 at week 2.Initial patient feedback regarding the new product was positive, and skin assessment results suggest the new seal may help improve peristomal skin condition. Larger studies with longer patient follow-up are needed to confirm the results of this pilot evaluation.