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New study aims to reduce skin problems for ostomy patients

NCT ID NCT07460323

Disease control Sponsor: Hollister Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study will compare two types of ostomy seals (one with aloe) in 107 adults who recently had ostomy surgery in the UK. The goal is to see which seal better prevents skin complications like irritation, bleeding, and growths around the stoma. Participants will use the product starting at their first pouch change and be monitored for complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ostomy seal (absorptive device) and ostomy ring (with aloe)
What this could lead to
If successful, this could show which ostomy seal better prevents skin irritation and bleeding after surgery, improving comfort for people with an ostomy.
What could go wrong
This is a small, early-stage study with no blinding or placebo, so results may not apply to all patients. The products are already on the market, so no breakthrough is expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 107 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OSTOMY

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • East Surrey Hospital

    RECRUITING

    Redhill, Surrey, RH1 5RH, United Kingdom

  • East Sussex Healthcare NHS Trust: Conquest and Eastbourne Hospitals

    RECRUITING

    Saint Leonards-on-Sea, East Sussex, TN37 7RD, United Kingdom

  • North Tees University Hospital

    RECRUITING

    Stockton-on-Tees, County Durham, TS19 8PE, United Kingdom

  • Queen Elizabeth The Queen Mother Hospital

    RECRUITING

    Margate, Kent, CT9 4AN, United Kingdom

  • University Hospital Coventry

    RECRUITING

    Coventry, West Midlands, CV2 2DX, United Kingdom

  • William Harvey Hospital

    RECRUITING

    Ashford, Kent, TN24 0LZ, United Kingdom

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