Two Ostomy Seals/Rings after surgery
Official title: Study of TRE Seals on Early Post-operative Subjects
Run by Hollister Incorporated · NCT07460323 · Data updated 2026-11-12
This study tests two ostomy seals/rings in adults who recently had ostomy surgery in the UK to see if they fit better and protect the skin.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 107 (estimated) |
| Sponsor | Hollister Incorporated Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 6 sites (Stockton-on-Tees, County Durham and 5 other locations) |
| Status | Recruiting |
| Started | June 30, 2026 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07460323 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older in the UK who have had ostomy surgery with no planned reversal during the study, and who can use a barrier seal after surgery.
✕Probably not a fit
Patients with severe peristomal skin conditions, fistulas, or those outside the short post-operative window may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates two ostomy seal and ring devices in adults after ostomy surgery. Eligible participants are 18 or older, with a colostomy, ileostomy, or urostomy in the UK, who have no reversal planned during the evaluation period, and can have the first product applied within four days post-op. The trial compares an Ostomy Seal and an Ostomy Ring as barrier devices to support post-operative care. Exclusion criteria include age over 85, recent or planned chemotherapy/radiation, active peristomal skin issues with a high PSC score, or a peristomal fistula. The study is sponsored by Hollister Incorporated and conducted at three UK sites.
Why it matters
Potential benefit: If successful, patients could experience a better-fitting barrier that reduces skin irritation and improves pouching security after ostomy surgery.
How similar studies have gone: Previous work with ostomy barriers suggests potential improvements in skin protection and containment, but this exact comparison of a seal versus a ring is relatively new.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
North Tees University Hospital
Stockton-on-Tees, County Durham, United Kingdom Recruiting -
East Sussex Healthcare NHS Trust: Conquest and Eastbourne Hospitals
Saint Leonards-on-Sea, East Sussex, United Kingdom Recruiting -
William Harvey Hospital
Ashford, Kent, United Kingdom Recruiting -
Queen Elizabeth The Queen Mother Hospital
Margate, Kent, United Kingdom Recruiting -
East Surrey Hospital
Redhill, Surrey, United Kingdom Recruiting -
University Hospital Coventry
Coventry, West Midlands, United Kingdom Recruiting
Study contacts
- Study coordinator: John Whitaker; Chief Investigator
- Email: John.Whitaker@uhcw.nhs.uk
- Phone: 024 7696 7148
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Telephone follow-up by a WOC nurse after ostomy surgery
We’re testing whether a WOC nurse’s phone check-in after ostomy surgery can reduce hospital readmissions for adults with a new ostomy.
-
Using a 3D model to educate patients before urologic bowel surgeries
This study is testing if using a 3D model to teach patients about urologic bowel surgeries can help them understand their care better and improve their overall experience.
-
New device for managing post-surgical ostomy complications
This study is testing a new device called the Limpet to see if it can help people with ostomies and fistulas have fewer skin problems and leaks compared to regular ostomy pouches.
-
Personalized 3D Printed Ostomy Appliance
This study is testing if a custom 3D printed ostomy appliance can help people with ostomies feel more comfortable and satisfied compared to their regular appliance.
-
Training to improve quality of life for individuals with a stoma
This study tests whether a special training program can help people with a stoma feel better and become more independent in managing their care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.