Peristomal and surrounding skin barrier health in people with a stoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects preliminary data on the skin barrier properties around a stoma and on comparable skin areas nearby. Participants will have a single 1-hour visit during which non-invasive tests are performed, including microbiome swabs, Raman spectroscopy skin profiling, and biophysical measurements of skin condition (color, redness, elasticity, sebum, and pH) on peristomal and non-peristomal sites. The goal is to understand similarities or differences in skin barrier characteristics across stoma types and to identify factors that influence peristomal skin health. Findings may inform future strategies to support skin integrity and stoma adhesion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult 18 years or over
* Have a stoma (colostomy, ileostomy or urostomy)
* Have healthy peristomal skin
* Have the ability to provide informed consent
* Are independently mobile
* Can stop using any stoma paste, cream, sprays or lotions on peristomal skin 1 day (24hrs) prior to the study appointment
* Are independent with stoma care management
* Are able to attend study appointment in Birmingham, UK

Exclusion Criteria:

* Have a current skin condition, such as eczema, psoriasis, or infection around the skin test site areas
* Have bleeding or broken peristomal skin
* Are currently taking any of the following medications: steroids, nicotine patches, acne medication (e.g., Accutane), any medication know to affect the properties of the skin
* Use patches on your abdomen, such as HRT patches
* Are receiving or have had radiotherapy or chemotherapy in the last 2 months
* Are taking or have had antibiotic treatment in the last 4 weeks
* Are currently receiving any stoma care treatment under a stoma care nurse specialist
* Have tattoos in the skin test site areas
* Are pregnant
* Have excessive hair on your abdomen
* Have participated in another skin testing study within the last 8 weeks

Where it's running

• Salts Healthcare
  Birmingham, United Kingdom Recruiting

Study contacts

• Principal investigator: Mireille Hamson — Salts Healthcare
• Study coordinator: Samantha Jarvis
• Email: samantha.jarvis@salts.co.uk
• Phone: 01213332015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.