The 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
- 5
- 试验地点
- 2
- 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 adhesion of new 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 (tablet/injection) treatment.
- •Are pregnant or breastfeeding
- •Having dermatological problems in the peri-stomal- 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 adhesive strips
On the peristomal skin 4 different patches are applied to the skin (Standard hydrocolloid adhesive patch; LT-2, LT21 and 33-20. There is a bag welded to each patch. Tthe bag contains real output.
The difference between the four patches is that they are made of four different adhesives.
The primary endpoint is measured after 8 hours and 24 hours.
干预措施: LT-21 (Other)
Test of new adhesive strips
On the peristomal skin 4 different patches are applied to the skin (Standard hydrocolloid adhesive patch; LT-2, LT21 and 33-20. There is a bag welded to each patch. Tthe bag contains real output.
The difference between the four patches is that they are made of four different adhesives.
The primary endpoint is measured after 8 hours and 24 hours.
干预措施: Standard hydrocolloid adhesive patch (Other)
Test of new adhesive strips
On the peristomal skin 4 different patches are applied to the skin (Standard hydrocolloid adhesive patch; LT-2, LT21 and 33-20. There is a bag welded to each patch. Tthe bag contains real output.
The difference between the four patches is that they are made of four different adhesives.
The primary endpoint is measured after 8 hours and 24 hours.
干预措施: LT-2 (Other)
Test of new adhesive strips
On the peristomal skin 4 different patches are applied to the skin (Standard hydrocolloid adhesive patch; LT-2, LT21 and 33-20. There is a bag welded to each patch. Tthe bag contains real output.
The difference between the four patches is that they are made of four different adhesives.
The primary endpoint is measured after 8 hours and 24 hours.
干预措施: 33-20 (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 will increase leading to an increase in the trans epidermal water loss.Thus, trans epidermal water loss is used to assess the damage to the skin. Maesurents are taken at time 0 and after 8 hours of output exposure to the skin.
次要结局
未报告次要终点