Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colostomy - Stoma, Ileostomy - Stoma, Urostomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characterisation in People Living With a Stoma.
Overview
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
Detailed description
Healthy peristomal skin is vital, not only for stoma bag adherence and the prevention of leakages but for the stability to the skin barrier function. Peristomal skin refers to area surrounding a stoma and skin under the stoma bag adhesive. There is a lack of information and understanding on peristomal skin health and its skin barrier qualities. The study aims to gather data on peristomal and non-peristomal skin barrier characterisation in people living with a stoma. Participants enrolled in the study will undertake the following skin testing procedures:
* Microbiome skin swabbing of peristomal and non-peristomal skin area * Skin profiles with Raman Spectrometer of the peristomal and non-peristomal skin * Biophysical skin property testing (skin damage, skin colour, redness, elasticity, sebum and pH) of the peristomal and non-peristomal skin
Primary outcome measures
- Assessment description of skin microbial composition of peristomal and non-peristomal skin [Time frame: Study appointment (1 hour)]
- Assessment of skin barrier chemical composition including water (mass-%), ceramides & fatty acids urea, lactate, protein, natural moisturising factors (NMF) and stratum corneum (SC) thickness of peristomal and non-peristomal skin [Time frame: Study Appointment (1 hour)]
- Biophysical skin properties including Transepidermis water loss (TEWL), redness and skin colour, elasticity, sebum and pH of peristomal and non-peristomal skin [Time frame: Study Appointment (1 hour)]
Secondary outcome measures (3)
- Compare microbiota analysis of each peristomal skin stoma type (Colostomy, Ileostomy and Urostomy) [Time frame: Study Appointment (1 hour)]
- Compare skin barrier chemical composition including water (mass-%), ceramides & fatty acids urea, lactate, protein, natural moisturising factors (NMF) and stratum corneum (SC) thickness of each stoma type peristomal skin [Time frame: Study Appointment (1 hour)]
- Compare biophysical skin properties including Transepidermis water loss (TEWL), redness and skin colour, elasticity, sebum and pH of stoma type (Colostomy, Ileostomy and Urostomy) peristomal skin [Time frame: Study Appointment (1 hour)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Salts Healthcare — Birmingham
Identifiers
NCT: NCT07719309 · 26/HRA/1622