NCT02223104已完成4 期
Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy
BBraun Medical SAS1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2013年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura.
研究概览
简要总结
The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.
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
- •patient is at least 18 years old
- •patient having a colostomy with a diameter less than 50 mm for users of midi pouches or having a colostomy with a diameter less than 65 mm for users of maxi pouches
- •patient having a colostomy for at least 1 month
- •patient using currently a one-piece flat ostomy appliance with closed or drainable bags
- •patient using minimum 1 product per day with closed pouches or minimum 1 product every two days with drainable pouches
- •patient capable to apply and remove the pouch himself or with the help of a caregiver (except health care professional)
- •patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
- •patient agrees to test Flexima® Active (size midi or maxi, beige) during 14 days and Sensura® (size midi or maxi, beige) during 14 days
- •patient covered by social security
排除标准
- •patient receiving or having received, within the last month, chemotherapy or radiotherapy
- •patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
- •patient currently receiving or having received within the past three weeks systemic or local steroid medication in the peristomal skin
- •patient already participating in another clinical study or who have previously participated in this investigation
- •pregnant or breast-feeding woman
结局指标
主要结局
Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura.
时间窗: Up to one day for closed pouches and up to two days for drainable pouches.
The patient will evaluate the level of leakage under the skin protector after each removal of pouch. A 4 scale level will be used: * "no leakage under the skin protector", * "leakage under the skin protector not soiling clothes", * "leakage under the skin protector soiling clothes", * "sudden and massive leakage under the skin protector".
次要结局
- Assessment of the condition of peristomal skin(At V1 and V2 protocol visits (at day 0 and day 14))
- Preference between Flexima® Active and Sensura®(At each protocol visits (at day 0, day 14 and day 28))
- Assessment of the quality of life with Stoma-QoL questionnaire(At each protocol visits (at day 0, day 14 and day 28))
- Acceptability of each pouch(At each protocol visit (day 0, day 14 and day 28))
- Adverse(s) Event(s)(At each protocol visits (at day 0, day 14 and day 28))
研究者
研究点 (1)
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