Study of TRE Seals on Early Post-operative Subjects

Study of TRE Seals on Early Post-operative Subjects

This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.

Inclusion Criteria:

1. At least 18 years of age
2. Has their ostomy surgery and post-operative care in the United Kingdom (UK)
3. Has a colostomy, ileostomy, or urostomy and no reversal planned during the study evaluation period
4. Able to have first study product applied at first pouch change after surgery (or up to 4 days post-op)
5. Is appropriate to use a barrier seal per the Investigator
6. Able to provide an informed consent for study participation
7. Willing to follow protocol procedures, including participating in study visits, as demonstrated by signing the informed consent

Exclusion Criteria:

1. Is over 85 years of age
2. Has received chemotherapy or radiation in the past 30 days or reports beginning chemotherapy or radiation during the study.
3. A score of 1, 2, or 3 for any of the three OCSI Tool PSC-related domains (i.e., peristomal irritant dermatitis, peristomal bleeding, and hyperplasia) at time of enrollment
4. Has a fistula in the peristomal area at time of enrollment
5. Has an open draining wound (not including mucocutaneous separation) in the peristomal area at time of enrollment
6. Has a suspected infection in the peristomal area at time of enrollment
7. Is pregnant or lactating at time of enrollment (as determined by interview only)
8. Is unable to speak, read, and understand English.
9. Is currently participating in another clinical study using ostomy products
10. Is currently an employee of Hollister Incorporated or any ostomy manufacturer