Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma (Stoma Imprint)
2026年7月17日 更新者：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
研究概览
地位
尚未招聘
详细说明
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
研究类型
观察性的
注册 (估计的)
108
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Samantha Jarvis
- 电话号码：01213332015
- 邮箱：samantha.jarvis@salts.co.uk
研究联系人备份
- 姓名：Mireille Hamson
- 邮箱：mireille.hamson@salts.co.uk
学习地点
-
-
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Birmingham、英国、B7 4AA
- Salts Healthcare
-
接触：
- Samantha Jarvis
- 电话号码：01213332015
- 邮箱：samantha.jarvis@salts.co.uk
-
接触：
- Mireille Hamson
- 电话号码：07827997423
- 邮箱：mireille.hamson@salts.co.uk
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首席研究员：
- Mireille Hamson
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The study population will be recruited from Birmingham UK and the surrounding areas (up to a distance of 150 miles)
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
People Living with a Stoma
Colostomy, Ileostomy, Urostomy
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment description of skin microbial composition of peristomal and non-peristomal skin
大体时间：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
大体时间：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
大体时间：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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Compare microbiota analysis of each peristomal skin stoma type (Colostomy, Ileostomy and Urostomy)
大体时间：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
大体时间：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
大体时间：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)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between peristomal skin barrier characterisation and stoma type/function and management
大体时间：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:
|
Study Appointment (1 hour)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mireille Hamson、Salts Healthcare
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2028年5月1日
研究完成 (估计的)
2028年5月1日
研究注册日期
首次提交
2026年7月14日
首先提交符合 QC 标准的
2026年7月17日
首次发布 (实际的)
2026年7月22日
研究记录更新
最后更新发布 (实际的)
2026年7月22日
上次提交的符合 QC 标准的更新
2026年7月17日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 26/HRA/1622
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.