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.

Exclusion Criteria:

- Has known skin sensitivity to any component of the products being tested.

- Has a skin rating of "2" or greater according to the Skin Rating Scale.

- Is receiving radiation in the area of the pouching system.

- Is receiving chemotherapy other than a stable regimen of maintenance chemotherapy.

- Requires a pouch belt while wearing Vitala

- Requires convexity or a moldable skin barrier.

- Has participated in a clinical study within the past 90 days.