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NCT07719309
Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
Conditions: Colostomy - Stoma, Ileostomy - Stoma, Urostomy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 108
Sponsor: Salts Healthcare
Location: Salts Healthcare Birmingham
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 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
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
Source: ClinicalTrials.gov (NCT07719309). StuddyBuddy aggregates publicly available trial information.