Not yet recruitingOBSERVATIONAL

Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma

This study aims to understand the skin around a stoma, called peristomal skin, and compare it to other healthy skin on the body. Doctors want to learn more about how healthy peristomal skin stays that way, which is important for keeping stoma bags secure and preventing leaks. They are particularly interested in whether different types of stomas (colostomy, ileostomy, or urostomy) affect the skin differently. If you take part, you'll have one appointment in Birmingham that lasts about an hour. During this appointment, some gentle, non-invasive tests will be done on your skin, both around your stoma and on another part of your body. This research will help medical teams better support people with stomas in the future.

At a glance

Status

Not yet recruiting

Sponsor

Salts Healthcare

Enrolment target

108

Start

01 Sep 2026

Estimated completion

01 May 2028

Colostomy - Stoma Ileostomy - Stoma Urostomy

What is this study about?

This research study is looking into the health of the skin around a stoma, which doctors call 'peristomal skin'. This skin needs to be healthy not only to help your stoma bag stick properly and prevent any leaks, but also because it acts as a very important barrier for your body. Currently, we don't fully understand what makes peristomal skin healthy or how different types of stomas might affect it.

The main aim of this study is to gather new information about this skin. We want to see if the skin around your stoma is different or similar to other healthy skin on your body. We also want to find out if having a colostomy, ileostomy, or urostomy changes the qualities of the skin around it. Understanding these things better will help healthcare professionals give the best advice and care to people with stomas.

By taking part, you’ll help us learn more about healthy stoma skin. This knowledge could lead to better ways to support people with stomas in the future, helping to prevent skin problems and improve comfort and quality of life.

Key takeaways

It's a study looking at skin health around a stoma.
Compares stoma skin to other skin on the body.
Examines how different stoma types (colostomy, ileostomy, urostomy) affect skin.
Involves one short, gentle appointment in Birmingham.
Tests are non-invasive and won't break the skin.
Helps improve future care for people with stomas.

Who may be eligible?

To be able to take part in this study, you need to be an adult aged 18 or older and have a colostomy, ileostomy, or urostomy. It's important that the skin around your stoma is currently healthy, without any rashes, infections, bleeding, or broken areas. You should also be able to move around on your own, look after your stoma without help, and be able to travel to Birmingham for the study appointment. We also ask that you stop using any creams, sprays, or lotions around your stoma for one day (24 hours) before your appointment.

There are some reasons why you might not be able to join. For example, if you have a skin condition like eczema or psoriasis near the test areas, or if you're currently taking certain medications like steroids or acne treatments that affect your skin. You also can't take part if you've had radiotherapy or chemotherapy in the last two months, or antibiotics in the last four weeks. If you're pregnant, have tattoos on the skin where tests would be done, or have a lot of hair on your tummy, you wouldn't be able to join either. You also can't participate if you've been part of another skin testing study in the last eight weeks.

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 or older?
Do you have a colostomy, ileostomy, or urostomy?
Is the skin immediately around your stoma currently healthy (no redness, broken skin, or infection)?
Can you travel to Birmingham for a 1-hour appointment?
Are you able to manage your stoma care independently?
Are you able to pause using creams/sprays on stoma skin for 24 hours before the appointment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will need to attend a single appointment in Birmingham, UK. This appointment will last for about 1 hour. During this visit, a few gentle and non-invasive tests will be done on your skin. These tests involve: taking simple swabs of your skin (a bit like using a cotton bud), using a special light machine to look at your skin's make-up, and checking things like skin moisture, colour, redness, how stretchy it is, and its pH level. You will be asked to stop using any stoma pastes, creams, sprays, or lotions on the skin around your stoma for 24 hours before your appointment. There are no follow-up appointments after this single visit.

Potential risks and benefits

The main benefit of taking part in this study is helping researchers gain a better understanding of stoma skin health, which could lead to improved care for people with stomas in the future. The risks involved are very low; the skin tests are non-invasive and generally well-tolerated. However, as with any research, there's always a small chance of unexpected discomfort or a mild reaction during the skin tests. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Salts Healthcare
Verified postcode
Birmingham, United Kingdom

Common questions

What is 'peristomal skin'?

It's the skin directly around your stoma and under your stoma bag adhesive.

Will any of the skin tests hurt?

No, the tests are gentle and non-invasive, meaning they don't break the skin. They are similar to simply touching the skin.

Do I need to stop using my stoma products?

You'll need to stop using stoma paste, creams, sprays, or lotions on your peristomal skin for 24 hours before your appointment.

Where does the study take place?

The study appointment will be in Birmingham, UK.

How long will I need to commit?

You only need to attend a single 1-hour appointment.

How to find out more

Samantha Jarvis

samantha.jarvis@salts.co.uk 01213332015 Official trial record

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