Clinical Comparison of a Moldable Skin Barrier versus a Shape-to-Fit

Clinical Comparison of a Moldable Skin Barrier versus a Shape-to-Fit

Skin Barrier in Healthy Volunteers

A crossover comparative clinical evaluation of a moldable skin barrier to a shape to fit skin barrier was conducted among 60 healthy volunteers with a stoma in three study centers within the United States.  The evaluation was completed over a four-week study period during which each subject was randomized to one of the test skin barriers for a two-week study period, followed by a second two-week period wearing the other test skin barrier.  Evaluation points included peristomal skin evaluations, ability of the test skin barrier to provide a snug, secure fit around the stoma, wear-time, leakage, comfort, ease of application, and overall performance.

Data analysis was performed with the statistics software IBM SSPS Statistics version 20™ for Windows. Statistical analysis of subject population of all enrolled subjects was defined as all subjects enrolled and entered Stage 1 of the study. The subject disposition, demographics and baseline characteristics were recorded. Continuous data was summarized using descriptive statistics (n, mean, median, range, standard deviation). Categorical data is presented in contingency tables as frequencies and percentages. Descriptive statistics were used to summarize baseline patient characteristics, patient disposition including safety, efficacy and performance parameters.A Standard summary of statistical measures is included for all primary and secondary endpoints.Continuous variables are summarized by number of valid cases, means, and standard deviation, median, maximum and 95%, confidence interval. Categorical variables were summarized as the number and percentage of subjects enrolled.