NCT01935999已完成2 期
A Single Center Study to Assess the Safety and Performance of a One Piece Closed Pouch in Subjects With a Colostomy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.
详细描述
Twelve subjects are to be recruited into this 10 day single centre study to assess primarily safety in terms of adverse events and condition of the skin surrounding the stoma and condition of the stoma. Performance will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Of legal consenting age and able to provide written informed consent
- •Is able to read, write, and understand the primary language of the investigative site.
- •Have a colostomy for more than 3 months
- •Currently a one or two piece closed or drainable pouch user (all attempts will be made to include ConvaTec Active Life or Esteem Plus one piece closed pouch users)
- •Have unbroken peri-stomal skin (healthy normal skin to L1 on the SACs Instrument Scale # 1)
- •Have a stoma considered 'normal' in appearance in accordance with the stoma, color, moisture and structure rating scales
- •Be willing to wear a one piece closed pouch with moldable wafer according to the usual wear pattern of this type of pouch
- •Be willing to participate in the trial for 10 days plus 1 visit prior to the in-residence study period.
- •Be willing to remain in residence for 3 days at a central location
- •Be willing to meet with the investigator for a total of nine scheduled visits.
- •Be willing to discontinue the use of pastes, adhesive strips and rings/seals used to seal the area between the skin barrier wafer and stoma during the use of the study device
- •Other than their colostomy considered to have a healthy/stable health status
- •Have good manual dexterity and be able to take care of their stoma independently
- •Be willing and able to complete a diary card for the duration of the study.
- •Be willing to take photographs of the stoma and pouch on pouch removal
排除标准
- •Subjects with a history of sensitivity to any one of the ostomy products or the components being studied
- •Subjects with stoma duration of less than 3 months
- •Subjects who currently use a belt with their usual appliance
- •Subjects who have been entered into the study before, or who have previously taken part in a study in the last month.
- •Subjects who require convexity or other skin fillers (pastes, seals, or rings) to even undulations of the peristomal skin
- •Subjects undergoing chemotherapy or radiotherapy
- •Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
结局指标
主要结局
Safety
时间窗: 10 days - duration of study period
Safety in relation to type and number of adverse events, condition of the skin surrounding the colostomy stoma and condition of the stoma
次要结局
- Performance/Efficacy(10 days duration of study period)
研究者
研究点 (2)
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