Clinical Trials in the UK / NCT07460323
Recruiting
Not applicable
Study of TRE Seals on Early Post-operative Subjects
NCT07460323 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Ostomy
Investigational drug(s) / intervention(s)
An Ostomy SealAn Ostomy Ring
An Ostomy Seal: An absorptive ostomy seal
An Ostomy Ring: The Ostomy Ring contains Aloe
Study summary
This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.
Eligibility
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
Primary outcome measure(s)
- The Risk of Peristomal Skin Complications (PSCs) as measured using the three PSC-related questions on the Ostomy Complication Severity Index (OCSI) — From enrollment to the end of treatment at 9 weeks
The three PSC-related questions on the Ostomy Complication Severity Index (OCSI) are related to peristomal irritant dermatitis, peristomal bleeding, and hyperplasia. Each of these three items is rated on a scale of 0-3, with 0 indicating absence of the condition, and 3 indicating the condition is severe.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| North Tees University Hospital | Stockton-on-Tees | County Durham | Recruiting |
| East Sussex Healthcare NHS Trust: Conquest and Eastbourne Hospitals | Saint Leonards-on-Sea | East Sussex | Recruiting |
| William Harvey Hospital | Ashford | Kent | Recruiting |
| Queen Elizabeth The Queen Mother Hospital | Margate | Kent | Recruiting |
| East Surrey Hospital | Redhill | Surrey | Recruiting |
| University Hospital Coventry | Coventry | West Midlands | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07460323 on ClinicalTrials.gov ↗ ← All trials in the UK