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Набор скоро начнётся NCT07719309

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

— Наблюдательное Colostomy - Stoma Ileostomy - Stoma Urostomy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Colostomy - Stoma, Ileostomy - Stoma, Urostomy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

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

Обзор

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

Подробное описание

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

Первичные конечные точки

  • Assessment description of skin microbial composition of peristomal and non-peristomal skin [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Study Appointment (1 hour)]
Вторичные конечные точки (3)
  • Compare microbiota analysis of each peristomal skin stoma type (Colostomy, Ileostomy and Urostomy) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Study Appointment (1 hour)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • Salts Healthcare — Birmingham

Идентификаторы

NCT: NCT07719309 · 26/HRA/1622

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗