A prospective multicenter evaluation of a moldable stoma skin barrier.

Abstract

Ostomy skin barriers can be difficult to size and shape; gaps between the skin and the appliance can compromise peristomal skin protection. A multicenter evaluation was initiated to assess the satisfaction of persons with ostomies (n = 172, mean age 56.6 years) and enterostomal therapy nurses (ETs, n = 49; number of evaluations = 195) with a new moldable skin barrier. The majority (116) of participants had ostomy surgery >90 days before the evaluation. Study participants received up to five product samples. Evaluation forms included stoma background information and questions regarding the product's ease of application and molding, ease of creating a customized fit, adherence of the hydrocolloid collar, ability to shape and reshape, effectiveness of skin protection, level of satisfaction with the product, and concerns/problems. At baseline, skin irritation was noted in 41% of ET evaluations and by 46% of participants with a stoma and cited as a reason to discontinue product usage in 11 ET reports (6.4%) and by seven users (3.6%). Regardless of the type of ostomy surgery, the percentage of "very good"/"excellent" ratings from participants for all evaluation criteria was 84.2% for colostomies, 85.4% for ileostomies, and 92.5% for urostomies. Similarly, for the ET evaluations, the percentage of "very good"/"excellent" ratings for all evaluation criteria was 89.0% for colostomies, 92.7% for ileostomies, and 92.7% for urostomies and 87% of ETs noted that teaching product usage was easy. Although interpretation of the results is limited by the study design, these findings confirm previous reports that the prevalence of skin irritation among ostomy patients is high and suggest that the barrier evaluated is comfortable and easy to use. Controlled clinical studies to compare the safety and effectiveness of ostomy appliances as well as their effect on patient quality of life are needed.