Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSalts Healthcare
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult 18 years or over
Have a stoma (colostomy, ileostomy or urostomy)
Have healthy peristomal skin
Have the ability to provide informed consent
Disqualifiers
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
Trial population
The study population will be recruited from Birmingham UK and the surrounding areas (up to a distance of 150 miles)
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
108 Participants
are grouped into 1 trial groupGroup A: People Living with a Stoma
Trial outcomes
Primary outcomes
1
Assessment description of skin microbial composition of peristomal and non-peristomal skin
Each participant will provide four skin swab samples for microbiome profiling: two swabs from the peristomal (experimental) test site area and two swabs from the non-peristomal (control) test site area, on the opposite side of the abdomen. To Identify microbial species, present in peristomal and non-peristomal area using Metagenomic Shotgun Sequencing
Time frame
Study appointment (1 hour)2
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
6 High Wavenumber profiles of water (mass%) and SC thickness (Microns) and 6 Fingerprint profiles of ceramides \& fatty acids urea, lactate, protein and natural moisturising factors (NMF) from peristomal skin (experimental) test site area and non-peristomal (control) skin test site area, using the Raman spectrometer
Time frame
Study Appointment (1 hour)3
Biophysical skin properties including Transepidermis water loss (TEWL), redness and skin colour, elasticity, sebum and pH of peristomal and non-peristomal skin
Measurement of Transepidermal water loss (TEWL) with Tewameter, skin colour (melanin) and skin redness (erythema) with Mexameter, elasticity and firmness with Cutometer, sebum level with Subumeter and pH with pH Meter from peristomal area (experimental) skin test and non-peristomal (control) skin test area
Time frame
Study Appointment (1 hour)Secondary outcomes
1
Compare microbiota analysis of each peristomal skin stoma type (Colostomy, Ileostomy and Urostomy)
Compare matched peristomal skin microbiomes within each stoma type. Explore associations between microbiome profiles and metadata (age, gender, ethnicity, stoma type, duration of stoma etc.)
Time frame
Study Appointment (1 hour)2
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
Compare High Wavenumber profiles of water (mass%) and SC thickness (Microns) and Fingerprint profile of ceramides \& fatty acids urea, lactate, protein and natural moisturising factors (NMF) from each stoma type (Colostomy, Ileostomy and Urostomy) peristomal skin (experimental) test site area, using Skin Tools Data Analysis Software
Time frame
Study Appointment (1 hour)3
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
Biophysical skin property testing, Transepidermis water loss (TEWL), redness and skin colour, elasticity, sebum and pH from each stoma type (Colostomy, Ileostomy and Urostomy) peristomal skin.
Time frame
Study Appointment (1 hour)Other outcomes
1
Correlation between peristomal skin barrier characterisation and stoma type/function and management
Participants will be asked specific stoma questions to capture responses for stoma type/function and management questions. To identify the following: * Stoma type/function * Stoma products * Peristomal skin condition * Stoma leakage frequency * Stoma appliance changes * Stoma accessory usage
Time frame
Study Appointment (1 hour)Sponsors and contacts
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Source ClinicalTrials.gov