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

Recruitingn/aAges 18 Years - anyAllSalts Healthcare
NCT07719309 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this exploratory study is to obtain preliminary data on peristomal and non-peristomal skin barrier characterisation in people living with a stoma. The main questions it aims to answer are: * Is there a difference/similarity in skin barrier characterisation of peristomal and non-peristomal skin in people living with a stoma? * Is there a difference/similarity in peristomal skin barrier function of different stoma types (colostomy, ileostomy and urostomy)? * Does a stoma type/function, influence skin barrier characterisation of peristomal skin? Participants will: * Attend a 1-hour study appointment * Undergo non-invasive skin procedures

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Salts Healthcare
Birmingham, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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