Not Yet RecruitingNot Applicable

Study of TRE Seals on Early Post-operative Subjects

107 participantsStarted 2026-06

Plain-language summary

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

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Is over 85 years of age
✕. Has received chemotherapy or radiation in the past 30 days or reports beginning chemotherapy or radiation during the study.
✕. 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
✕. Has a fistula in the peristomal area at time of enrollment
✕. Has an open draining wound (not including mucocutaneous separation) in the peristomal area at time of enrollment
✕. Has a suspected infection in the peristomal area at time of enrollment
✕. Is pregnant or lactating at time of enrollment (as determined by interview only)
✕. Is unable to speak, read, and understand English.

The Risk of Peristomal Skin Complications (PSCs) as measured using the three PSC-related questions on the Ostomy Complication Severity Index (OCSI)

Timeframe: From enrollment to the end of treatment at 9 weeks

NCT IDNCT07460323

SponsorHollister Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Is over 85 years of age
✕. Has received chemotherapy or radiation in the past 30 days or reports beginning chemotherapy or radiation during the study.
✕. 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
✕. Has a fistula in the peristomal area at time of enrollment
✕. Has an open draining wound (not including mucocutaneous separation) in the peristomal area at time of enrollment
✕. Has a suspected infection in the peristomal area at time of enrollment
✕. Is pregnant or lactating at time of enrollment (as determined by interview only)
✕. Is unable to speak, read, and understand English.