A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Swelling of the adhesive
研究概览
简要总结
This study investigates the adhesion of new adhesives to the skin.
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
- 是
入选标准
- •Have given written informed consent
- •Be at least 18 years of age and have full legal capacity
- •Have intact skin on the area used in the investigation
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 months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
- •Are pregnant or breastfeeding
- •Have dermatological problems in the abdominal area (assessed by investigator)
研究组 & 干预措施
Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
- Standard adhesive 1
- Standard adhesive 2
- LT-2
- LT-21
- LT-25
- 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
干预措施: Standard adhesive 1 (Other)
Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
- Standard adhesive 1
- Standard adhesive 2
- LT-2
- LT-21
- LT-25
- 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
干预措施: Standard adhesive 2 (Other)
Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
- Standard adhesive 1
- Standard adhesive 2
- LT-2
- LT-21
- LT-25
- 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
干预措施: LT-2 (Other)
Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
- Standard adhesive 1
- Standard adhesive 2
- LT-2
- LT-21
- LT-25
- 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
干预措施: LT-21 (Other)
Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
- Standard adhesive 1
- Standard adhesive 2
- LT-2
- LT-21
- LT-25
- 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
干预措施: LT-25 (Other)
Testing of new adhesive strips
Each subject will test six adhesive strips on pre-stripped skin.
- Standard adhesive 1
- Standard adhesive 2
- LT-2
- LT-21
- LT-25
- 33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
干预措施: 33-20 (Other)
结局指标
主要结局
Swelling of the adhesive
时间窗: 21 days
1\. Swelling of adhesive strips measured by weight (Difference between weight of strip before and after test)
次要结局
未报告次要终点