An Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characterisation in People Living With a Stoma.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Assessment description of skin microbial composition of peristomal and non-peristomal skin
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Assessment description of skin microbial composition of peristomal and non-peristomal skin
时间窗: 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
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
时间窗: 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
Biophysical skin properties including Transepidermis water loss (TEWL), redness and skin colour, elasticity, sebum and pH of peristomal and non-peristomal skin
时间窗: 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
次要结局
- Compare microbiota analysis of each peristomal skin stoma type (Colostomy, Ileostomy and Urostomy)(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(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(Study Appointment (1 hour))