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

17 juli 2026 uppdaterad 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

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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

Studietyp

Observationell

Inskrivning (Beräknad)

108

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

The study population will be recruited from Birmingham UK and the surrounding areas (up to a distance of 150 miles)

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
People Living with a Stoma
Colostomy, Ileostomy, Urostomy

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Assessment description of skin microbial composition of peristomal and non-peristomal skin
Tidsram: 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
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
Tidsram: 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
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
Tidsram: 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
Study Appointment (1 hour)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Compare microbiota analysis of each peristomal skin stoma type (Colostomy, Ileostomy and Urostomy)
Tidsram: Study Appointment (1 hour)
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.)
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
Tidsram: 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)
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
Tidsram: 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)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Correlation between peristomal skin barrier characterisation and stoma type/function and management
Tidsram: Study Appointment (1 hour)

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
Study Appointment (1 hour)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Salts Healthcare

Utredare

  • Huvudutredare: Mireille Hamson, Salts Healthcare

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 maj 2028

Avslutad studie (Beräknad)

1 maj 2028

Studieregistreringsdatum

Först inskickad

14 juli 2026

Först inskickad som uppfyllde QC-kriterierna

17 juli 2026

Första postat (Faktisk)

22 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 26/HRA/1622

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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