Colostomy - StomaStoma ImprintNCT07719309
Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
An observational study of Colostomy - Stoma and Ileostomy - Stoma, run by Salts Healthcare at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy - Stoma, Ileostomy - Stoma, Urostomy
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be recruited from Birmingham UK and the surrounding areas (up to a distance of 150 miles)
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mireille Hamson contact
United Kingdom1 site, 1 recruiting
- Recruiting
Salts Healthcare
Birmingham, B7 4AA
Samantha Jarvis, 01213332015, samantha.jarvis@salts.co.uk
Mireille Hamson, 07827997423, mireille.hamson@salts.co.uk
About this study
Official title: An Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characterisation in People Living With a Stoma.
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
Read the 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
- Conditions
- Colostomy - Stoma, Ileostomy - Stoma, Urostomy
- Keywords
- Peristomal skin, Skin Barrier Characterisation, People Living with a Stoma, Exploratory Study, Peristomal Skin Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People Living with a Stoma | Colostomy, Ileostomy, Urostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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
Measured: Study Appointment (1 hour)
Secondary outcomes (3)
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.)
Measured: 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
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
Measured: 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
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.
Measured: Study Appointment (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colostomy - StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salts Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mireille Hamson, Principal investigator, Salts Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719309
- Sponsor's protocol ID
- 26/HRA/1622
- Acronym
- Stoma Imprint
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characterisation in People Living With a Stoma.
- ClinicalTrials.gov ID
- NCT07719309
- Acronym / sponsor ID
- Stoma Imprint / 26/HRA/1622
- Conditions
- Colostomy - Stoma, Ileostomy - Stoma, Urostomy
- Keywords
- Peristomal skin, Skin Barrier Characterisation, People Living with a Stoma, Exploratory Study, Peristomal Skin Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Salts HealthcareIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People Living with a Stoma | – | –Colostomy, Ileostomy, Urostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be recruited from Birmingham UK and the surrounding areas (up to a distance of 150 miles)
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment description of skin microbial composition of peristomal and non-peristomal skin
Time frame: Study appointment (1 hour)
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
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)
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
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)
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
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mireille Hamson contact
Mireille Hamson principal investigator
Salts Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colostomy - Stoma and Ileostomy - Stoma, run by Salts Healthcare at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Jarvis (01213332015, samantha.jarvis@salts.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment description of skin microbial composition of peristomal and non-peristomal skin (time frame: Study appointment (1 hour)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.