Clinical study: peristomal skin irritation in colostomy patients

A prospective, controlled, clinical study was conducted to evaluate the effect of skin barriers and adhesives on the incidence of peristomal skin irritation. Colostomy patients eligible to participate were randomly assigned one of two sets of 10 one-piece pouching systems. At mid-study, after using the first 10 pouches, patients were allocated 10 pouches from the alternate pouching system. Each pouching system was worn for a maximum of 24 hours. One-hundred twelve patients were enrolled in the study. At baseline, 8 percent of patients had some erythema. At the end of the study period, 26 percent of patients exhibited signs of skin irritation. Patients were significantly more likely to develop skin irritation following use of the Karaya-based barrier than following use of the pectin-based barrier product (Wilcoxon Rank Sum Test, p < 0.01). Similarly, the type of tape used to secure the pouching system significantly influenced the incidence of skin irritation. Analysis of the change in skin condition as it relates to all evaluated variables; i.e. pouching system, stoma shape, stoma size, stoma length and irrigation, showed that only the type of product used was significantly associated with a change in skin condition. This is the first report of a controlled clinical study to evaluate the effect of pouching systems and patient/stoma variables on skin integrity in colostomy patients. These findings confirm that skin irritation can be a considerable problem, even in patients who use irrigation techniques.(ABSTRACT TRUNCATED AT 250 WORDS)