An Explorative Study Investigating Differences on the Peristomal Skin Condition by Optical Coherence Tomography (OCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Thickness of the epidermal layer (assessed by OCT)
研究概览
简要总结
An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT) 12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled.
The investigation consists of 2 visits, a screening visit (V0) and a Baseline/test visit (V1). V1 will also terminate the study period .The total study duration will be extended to a maximum of approximately 1 week, depending on the interval between V0 and V1.
详细描述
An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT)
12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled. Subjects will use their standard of care ostomy device as intended and remove the device at the test visit.
The investigation consists of 2 visits, a screening visit (V0) and a Baseline/test visit (V1). V1 will also terminate the study period when the OCT scan and other skin measurements has been completed. The total study duration will be extended to a maximum of approximately 1 week, depending on the interval between V0 and V1.
The OCT scans and other skin measurements (TEWL, Hydration and Erythema measurements) will be performed on the skin when the ostomy device has been removed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Has given written informed consent
- •Is at least 18 years old
- •Has full legal capacity
- •Has an ileostomy
- •Is using a flat 1-piece open ostomy device
- •Have had the ileostomy for a year
排除标准
- •Is currently receiving or have within the past two months received radio-and/or chemotherapy
- •Is currently receiving or have within the past month received steroid treatment in the skin area used in the investigation, e.g. lotion, spray, injection or tablet
- •Is pregnant or breastfeeding
研究组 & 干预措施
OCT scan + skin measurements abdominal and peristomal skin
OCT scan + skin measurements abdominal and peristomal skin
干预措施: flat 1-piece open ostomy device (Device)
结局指标
主要结局
Thickness of the epidermal layer (assessed by OCT)
时间窗: immediately after the OCT scan
Scan of the peristomal skin
次要结局
未报告次要终点