An Exploratory Study Investigating Human Skin Reaction to Output
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Trans Epidermal Water Loss After Test of Patches.
研究概览
简要总结
The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.
详细描述
Six types of patches are tested:
Patch 1: Standard adhesive with own feces
Patch 2: Standard adhesive with own feces mixture
Patch 3: Standard adhesive with simulated feces
Patch 4: Standard adhesive with simulated feces mixture
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Have given written informed consent
- •Be at least 18 years of age and have full legal capacity
- •Have had an ileostomy for more than one year
- •Have normal to slightly red skin on the area used in the evaluation
- •Has an ileostomy with a diameter up to (≤) 35 mm
- •Have a peristomal area accessible for applied patches (assessed by investigator)
排除标准
- •Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- •Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
- •Are pregnant or breastfeeding
- •Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
- •Participating in other interventional clinical investigations or have previously participated in this investigation
研究组 & 干预措施
Patch 1, 3 and 5
Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin
Measurements of skin at three locations of each patch: Center and under adhesive.
干预措施: Patch 1 (Other)
Patch 1, 3 and 5
Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin
Measurements of skin at three locations of each patch: Center and under adhesive.
干预措施: Patch 2 (Other)
Patch 1, 3 and 5
Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin
Measurements of skin at three locations of each patch: Center and under adhesive.
干预措施: Patch 3 (Other)
Patch 1, 3 and 5
Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin
Measurements of skin at three locations of each patch: Center and under adhesive.
干预措施: Patch 4 (Other)
Patch 1, 3 and 5
Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin
Measurements of skin at three locations of each patch: Center and under adhesive.
干预措施: Patch 5 (Other)
Patch 1, 3 and 5
Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin
Measurements of skin at three locations of each patch: Center and under adhesive.
干预措施: Patch 6 (Other)
Patch 2, 4 and 6
Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive.
干预措施: Patch 1 (Other)
Patch 2, 4 and 6
Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive.
干预措施: Patch 2 (Other)
Patch 2, 4 and 6
Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive.
干预措施: Patch 3 (Other)
Patch 2, 4 and 6
Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive.
干预措施: Patch 4 (Other)
Patch 2, 4 and 6
Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive.
干预措施: Patch 5 (Other)
Patch 2, 4 and 6
Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive.
干预措施: Patch 6 (Other)
结局指标
主要结局
Trans Epidermal Water Loss After Test of Patches.
时间窗: Approximately 7-10 hours
Trans Epidermal Water Loss is a standardized non-invasive method for describing the barrier function of the skin. Damage to the skin surface (stratum corneum) will lower the barrier of the skin and thereby increase water loss. This can be used as a measure for the damaging effect of the adhesives to the skin. Trans Epidermal Water Loss is measured by applying a probe to the skin surface and is assessed nine times for each patch after applying the patch: three repeated measurements of the skin covered by the center of the patch (Center), as well as three repeated measurements of the skin covered by the adhesive (Under adhesive).
次要结局
未报告次要终点