Multi-National Phase III Vitala™ 12-Hour Wear Test

Inclusion Criteria

• •Is of legal consenting age.
• •Is able to read, write, and understand the study, the required procedures, and the study related documentation.
• •Has signed the informed consent.
• •Has an end colostomy of at least 12 weeks duration with formed or semi- formed effluent.
• •Is able to wear a Natura® skin barrier wafer flange in size 45mm or 57 mm.
• •Is willing to remove and replace the skin barrier wafer after three days, more often if desired.
• •Has a stoma that protrudes no more than 2 cm at rest.
• •Has demonstrated success in wearing a traditional pouching system. (Investigator judgment)
• •Is willing to participate in the trial for a total of 215 days. (approximately 7 months)
• •Is willing to meet with the investigator for a total of 12 scheduled visits plus additional visits as deemed necessary by the investigator.
• •Has the ability to do complete self-care.