RecruitingNAINTERVENTIONAL

Study of TRE Seals on Early Post-operative Subjects

This study is investigating two types of stoma seals or rings, which are products designed to fit around a stoma to protect the skin and prevent leaks. The study is for people in the UK who have recently had stoma surgery (colostomy, ileostomy, or urostomy). Participants will try one of these seals or rings shortly after their operation. Researchers want to understand how these products perform in real-world use for new stoma patients. The two products being compared are an 'Ostomy Seal' and an 'Ostomy Ring'. By taking part, you would be helping medical professionals understand which products might work best for others in the future, ultimately aiming to improve comfort and care for people with stomas.

At a glance

Status

Recruiting

Phase

Sponsor

Hollister Incorporated

Enrolment target

107

Start

30 Jun 2026

Estimated completion

01 Mar 2027

Ostomy

What is this study about?

This research study is about finding the best ways to care for your skin after stoma surgery. When you have a stoma, it's really important to keep the skin around it healthy and protected from moisture that can leak from the stoma. Special products, often called seals or rings, are designed to fit snugly around your stoma to help with this.

In this study, doctors are looking at two different types of these seals or rings. They want to see how well each one works for people who have recently had stoma surgery. They'll be checking things like how comfortable the product is, how well it protects the skin, and if it helps prevent leaks. Your experience and feedback will be really valuable in helping them understand how these products perform.

The aim is to gather information that can help improve the care and comfort for everyone who has stoma surgery in the future. By taking part, you could be contributing to better options for stoma care, which is a really positive contribution to the stoma community.

Key takeaways

This study compares two stoma seals/rings for new stoma patients.
It helps improve skin protection and comfort for people with stomas.
You need to be aged 18-85 with recent stoma surgery in the UK.
Regular checks will monitor how the product works for you.
You can leave the study at any time without affecting your care.

Who may be eligible?

This study is specifically for adults aged between 18 and 85 years old who have recently had stoma surgery (a colostomy, ileostomy, or urostomy) here in the United Kingdom. It's important that your stoma surgery and all your early aftercare happen in the UK. You also need to be able to try the study product quite soon after your operation, within about four days of surgery or at your very first bag change. Your doctor will need to agree that using a barrier seal product is suitable for you.

There are also some reasons why you might not be able to join. For example, if you're pregnant or breastfeeding, or if you've recently had chemotherapy or radiation. If you have any skin problems around your stoma like a rash, bleeding, or an infection, or if you have a wound that's not related to your stoma opening, you won't be able to participate. You also need to be able to speak and understand English to give your consent and follow the study instructions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 to 85 years old?
Did you have your stoma surgery in the UK?
Do you have a colostomy, ileostomy, or urostomy?
Can you speak and understand English?
Do you NOT have any skin problems or infection around your stoma right now?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a chat with the study team and sign a consent form to show you understand and agree. You'll be asked to use one of the two special stoma seals or rings selected for the study. This product will be applied at your very first bag change after surgery, or within four days of your operation, by your healthcare team.

The study involves regular check-ups with your healthcare team to see how the product is working and how your skin around the stoma is doing. They might ask you questions about your comfort, any leaks you experience, and how easy the product is to use. The total duration of your participation in the study is not specified, but it will involve attending these study visits as requested by the team.

Potential risks and benefits

Taking part in this study may offer some benefits, such as receiving dedicated attention and regular check-ups from your healthcare team regarding your stoma care. You'll also be trying a product specifically designed to protect your skin, which could potentially improve your comfort. However, there are also potential risks, such as the possibility that the study product might not work as well for you as your usual care, or it could irritate your skin, although these products are generally designed to be safe. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

North Tees University Hospital
Verified postcode
Stockton-on-Tees, United Kingdom· Recruiting
East Sussex Healthcare NHS Trust: Conquest and Eastbourne Hospitals
Verified postcode
Saint Leonards-on-Sea, United Kingdom· Recruiting
William Harvey Hospital
Verified postcode
Ashford, United Kingdom· Recruiting
Queen Elizabeth The Queen Mother Hospital
Verified postcode
Margate, United Kingdom· Recruiting
East Surrey Hospital
Verified postcode
Redhill, United Kingdom· Recruiting
University Hospital Coventry
Verified postcode
Coventry, United Kingdom· Recruiting

Common questions

What exactly is a 'stoma seal' or 'ring'?

It's a soft, flexible product that your nurses place around your stoma to help protect the skin from moisture and waste, which can prevent irritation and leaks.

Will I get to choose which product I try?

No, the study will decide which of the two products you try. This helps them compare them fairly.

How long will I be in the study for?

The study description doesn't state the exact duration, but you would be involved in follow-up visits after the product is applied post-surgery. The study team will explain the full timeline when you discuss participation.

What if the product doesn't work for me?

You can stop using the study product and withdraw from the study at any time if you feel it's not right for you. Your medical care will not be affected.

Will I have extra appointments if I join?

Yes, you would have specific study visits where the team would check on your stoma and the product. The study team will give you details about the schedule.

How to find out more

John Whitaker; Chief Investigator

john.whitaker@uhcw.nhs.uk 024 7696 7148 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.