Evaluation of the Effect of Output on Newly Developed Adhesives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Trans epidermal water loss
研究概览
简要总结
The study investigates the impact real output has on the adhesion of the adhesives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 a stoma for more than one year
- •Have intact skin on the area used in the evaluation
- •Has a stoma with a diameter up to (≤) 35 mm
- •Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)
排除标准
- •Currently receiving or have within the past 2 month 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 (tab-let/injection) treatment.
- •Are pregnant or breastfeeding
- •Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
- •Actively participating in other interventional clinical investigations or have previously participated in this investigation.
研究组 & 干预措施
Test of new adhesives
On the peristomal area four different patches are applied to the skin. There is a bag welded on each patch. The bag contains real output.
The difference between the four patches is that they consist of different adhesives.
One patch is made of a standard hydrocolloid adhesive
The primary endpoint is maesured after 8 hours and 24 hours And the three other patches consist of the newly developed adhesives. P-4 P-15 P-16
干预措施: Standard hydrocolloid adhesive (Other)
Test of new adhesives
On the peristomal area four different patches are applied to the skin. There is a bag welded on each patch. The bag contains real output.
The difference between the four patches is that they consist of different adhesives.
One patch is made of a standard hydrocolloid adhesive
The primary endpoint is maesured after 8 hours and 24 hours And the three other patches consist of the newly developed adhesives. P-4 P-15 P-16
干预措施: P-15 (Other)
Test of new adhesives
On the peristomal area four different patches are applied to the skin. There is a bag welded on each patch. The bag contains real output.
The difference between the four patches is that they consist of different adhesives.
One patch is made of a standard hydrocolloid adhesive
The primary endpoint is maesured after 8 hours and 24 hours And the three other patches consist of the newly developed adhesives. P-4 P-15 P-16
干预措施: P-16 (Other)
Test of new adhesives
On the peristomal area four different patches are applied to the skin. There is a bag welded on each patch. The bag contains real output.
The difference between the four patches is that they consist of different adhesives.
One patch is made of a standard hydrocolloid adhesive
The primary endpoint is maesured after 8 hours and 24 hours And the three other patches consist of the newly developed adhesives. P-4 P-15 P-16
干预措施: P-4 (Other)
结局指标
主要结局
Trans epidermal water loss
时间窗: 8 hours
The trans epidermal water loss is measured on the peristomal skin using a probe. The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin.
次要结局
未报告次要终点