Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07719309

Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People 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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Colostomy - Stoma Ileostomy - Stoma Urostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  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

    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

  3. 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

Secondary outcomes

  1. Compare microbiota analysis of each peristomal skin stoma type (Colostomy, Ileostomy and Urostomy)

    Time frame: 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.)

  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

    Time frame: 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

  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

    Time frame: 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.

Other outcomes

  1. Correlation between peristomal skin barrier characterisation and stoma type/function and management

    Time frame: 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 contacts

Contact information is provided by the study sponsor or research team.

Mireille Hamson

CONTACT

[email protected]

Samantha Jarvis

CONTACT

[email protected]

01213332015

Sponsors and collaborators

Lead sponsor

Salts Healthcare

Industry

Registry information

Official study title

An Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characterisation in People Living With a Stoma.

Acronym: Stoma Imprint

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.