Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma (Stoma Imprint)
17. juli 2026 oppdatert av: Salts Healthcare
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
Studieoversikt
Status
Har ikke rekruttert ennå
Detaljert beskrivelse
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
Studietype
Observasjonsmessig
Registrering (Antatt)
108
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Samantha Jarvis
- Telefonnummer: 01213332015
- E-post: samantha.jarvis@salts.co.uk
Studer Kontakt Backup
- Navn: Mireille Hamson
- E-post: mireille.hamson@salts.co.uk
Studiesteder
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Birmingham, Storbritannia, B7 4AA
- Salts Healthcare
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Ta kontakt med:
- Samantha Jarvis
- Telefonnummer: 01213332015
- E-post: samantha.jarvis@salts.co.uk
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Ta kontakt med:
- Mireille Hamson
- Telefonnummer: 07827997423
- E-post: mireille.hamson@salts.co.uk
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Hovedetterforsker:
- Mireille Hamson
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The study population will be recruited from Birmingham UK and the surrounding areas (up to a distance of 150 miles)
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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People Living with a Stoma
Colostomy, Ileostomy, Urostomy
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Assessment description of skin microbial composition of peristomal and non-peristomal skin
Tidsramme: Study appointment (1 hour)
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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
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Study appointment (1 hour)
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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
Tidsramme: Study Appointment (1 hour)
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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
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Study Appointment (1 hour)
|
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Biophysical skin properties including Transepidermis water loss (TEWL), redness and skin colour, elasticity, sebum and pH of peristomal and non-peristomal skin
Tidsramme: Study Appointment (1 hour)
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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
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Study Appointment (1 hour)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Compare microbiota analysis of each peristomal skin stoma type (Colostomy, Ileostomy and Urostomy)
Tidsramme: Study Appointment (1 hour)
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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.)
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Study Appointment (1 hour)
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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
Tidsramme: Study Appointment (1 hour)
|
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
|
Study Appointment (1 hour)
|
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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
Tidsramme: Study Appointment (1 hour)
|
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.
|
Study Appointment (1 hour)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Correlation between peristomal skin barrier characterisation and stoma type/function and management
Tidsramme: Study Appointment (1 hour)
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Participants will be asked specific stoma questions to capture responses for stoma type/function and management questions. To identify the following:
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Study Appointment (1 hour)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mireille Hamson, Salts Healthcare
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. mai 2028
Studiet fullført (Antatt)
1. mai 2028
Datoer for studieregistrering
Først innsendt
14. juli 2026
Først innsendt som oppfylte QC-kriteriene
17. juli 2026
Først lagt ut (Faktiske)
22. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 26/HRA/1622
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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