Osmose Study: Multinational Evaluation of the Peristomal Condition in Ostomates Using Moldable Skin Barriers*

Objectives: The objectives of the study were to estimate the incidence and severity of peristomal skin lesions, evaluate the progression of peristomal skin condition, and assess the level of satisfaction in ostomates using a moldable skin barrier.*

Introduction: Patients adapting to an ostomy can encounter physical issues such as skin lesions or leaks, as well as psychosocial challenges of altered body image or quality of life.^1,2  A properly fitted barrier and intact peristomal skin are required to avoid a cycle of leakage and erosion, which can impact the patient both physically and psychosocially.³  Previous studies have shown that the use of moldable skin barriers* resulted in high levels of patient satisfaction and effective peristomal skin protection⁴; this study was designed to investigate this  further.

Methods & Materials: OSMOSE was an observational ,prospective, multicenter, multinational evaluation of a moldable skin barrier in ostomates with a colostomy, ileostomy, or urostomy. Patients enrolled in Group A used the moldable skin barrier as the first long-term system after stoma creation, and patients in Group B replaced a traditional skin barrier with the moldable skin barrier. Data was collected via case report forms at baseline, 8-15 days, 1 month and 2 months after baseline. Peristomal skin condition was assessed at each visit using a validated peristomal skin assesssment scale**. Patients rated their satisfaction with the moldable skin barrier at 1 month and 2 months using a validated questionnaire***.

Results: The study enrolled 623 patients from 67 centers in Germany, Poland, and USA. Results were analyzed by group and by stoma type.

Conclusion: Data on the use of a moldable skin barrier on patients with a colostomy, ileostomy or urostomy supported the expected benefits of improved peristomal skin condition and improved quality of life.