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The study aimed to estimate the incidence and severity of peristomal skin lesions, evaluate the progression of the peristomal skin condition and the impact on the quality of life in stoma patients using a moldable barrier.
Study was designed as an observational, prospective, multicentre study with two groups; group A: patients using the moldable device as the first system after stoma creation, and group B: patients having moldable device prescribed for persistent peristomal problems with rigid devices.
Data was collected by case study reports completed by the stoma care nurse at baseline assessment, then at 8, 15 days, 1 month, and 2 months. Peristomal skin condition was assessed at each consultation using the SACSTM scale4. The progression of the peristomal skin was evaluated comparing SACSTM values during the follow-up.
Patient satisfaction was evaluated through the analysis of patient mirror questionnaires completed at 1 and 2 months. The questionnaire, which focused on satisfaction regarding comfort, ease of use, confidence, and overall assessment has been validated previously in Spain5
860 patients were recruited. At the end of study, 2 months follow-up, among patients who completed study, 95.4% of group A (N=305) patients had normal skin or improved pre-existing lesions; 88.5% of group B (N=140) patients recovered normal skin or improved pre-existing lesions.
Among patients who completed final satisfaction evaluation, 92.6% of group A (N= 297) patients rated device comfort as excellent or good; in group B (N=137), 86.5% of patients rated the skin barrier very easy to mold.
Overall data supported expected benefits of the moldable skin barrier in terms of peristomal skin protection and QOL improvement.