NCT05641168已完成不适用
A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Adherent area
研究概览
简要总结
The study investigates different adhesive materials on healthy and peristomal skin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Has given written consent
- •Be at least 18 years of age and have full legal capacity
- •Have had a colostomy/ileostomy/urostomy for more than one year (for stoma patients) Have suitable peristomal skin area (assessed by investigator) (for stoma patients)
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 abdominal skin area or systemic steroid (tablet/injection) treatment
- •Are pregnant or breastfeeding
- •Having dermatological problems in the abdominal area (assessed by investigator)
- •Participate in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol
研究组 & 干预措施
Ostomy Adhesive material
Experimental
Newly designed ostomy adhesive material
干预措施: Adhesive material (Other)
comparator adhesive material
Other
Adhesive material already on the market e.g adhesive material from SenSura Mio ostomy product
干预措施: Standard adhesive material (Other)
结局指标
主要结局
Adherent area
时间窗: At every material change throughout the study, an average of 1 week
Adherent area (assessed by photos of adhesive materials)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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