Clinical Investigation Exploring a Newly Developed Ostomy Baseplate.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Maximum itching
研究概览
简要总结
Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, which affect their quality of life negatively.
Among the main reasons for developing PSCs are that the peristomal skin is exposed to stomal output either due to leakage of output under the baseplate and/or imperfect cutting of the hole in the baseplate, and incorrect application creating a gap between the hole in the baseplate and the stoma.
To seal this gap, Coloplast has developed a new ostomy baseplate and the aim of the investigation is to explore the investigational device 's ability to help protect the peristomal skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Has given written informed consent
- •Is at least 18 years old
- •Has full legal capacity
- •Has an ileostomy with consistent liquid faecal output (6-7 Bristol scale).
- •Has used flat SenSura Mio 1-piece or 2-piece for at least 14 days before the inclusion.
- •Has had the stoma for at least 90 days
- •Has a stoma size less than 45mm in diameter
- •Has experienced symptoms of peristomal skin complications such as itching, burning, or pain in the peristomal area within the last 14 days
- •Has suitable peristomal skin area (assessed by investigator) to participate in investigation
- •Is willing to refrain from analgesics within 24 hours before the test days
- •Is willing to refrain from antihistamine within 96 hours before the test days
- •Is willing to refrain from steroid treatment within 24 hours before the test days
排除标准
- •Is currently receiving or have within the past 60 days received radio-and/or chemotherapy.
- •low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for other indications than cancer.
- •Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray.
- •Is breastfeeding
- •Is pregnant based on urine pregnancy test.
- •Has known hypersensitivity towards any of the devices used in the investigation.
- •Participates 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
Investigational device
1 day treatment with investigational device
干预措施: CP381 (Device)
Comparator
1 day treatment with comparator
干预措施: CP381 (Device)
结局指标
主要结局
Maximum itching
时间窗: 6 hours
Maximum itching score between hour 4-6 after application of the investigational device and the comparator (scale from 0-10)
次要结局
未报告次要终点