Investigation of Patient Benefits With a New Supporting Ostomy Product and Support Service in Patients With a Newly Stoma Formation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks
研究概览
简要总结
People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.
To overcome this, Coloplast has developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Have provide written informed consent.
- •Be at least 18 years of age and have full capacity.
- •Have had their stoma for less than 9 months.
- •Have intact skin on the peristomal area (assessed by investigator)
- •Be able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)
- •Ileo- or colostomists with liquid and/or mushy output (Bristol scale type 5-7)
- •Is willing to refrain from use of paste and protective sheets.
- •Have a smartphone applicable for the HeyloTM app.
- •Have been self-managing stoma appliance for at least 14 days.
- •Are able to follow study procedures for 3 months (assessed by investigator)
- •Are willing to receive their ostomy products through Coloplast Charter for the duration of the study.
排除标准
- •Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- •Is breastfeeding.
- •Is pregnant based on urine pregnancy test.
- •Enrolled in another current research study or have previously participated in this investigation.
- •Has known hypersensitivity towards any of the products used in the investigation.
- •Is using/have a pacemaker.
- •Has a complicated stoma at baseline (dehiscence/prolapse/hernia)
- •Has limited life expectancy or receive palliative care.
- •Has stage 4 cancer.
- •Having more than one stoma synchronously
- •Having ongoing non-healed abdominal wounds
- •Reoperation / stoma reversal planned during the study period.
结局指标
主要结局
Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks
时间窗: Baseline (Day 0) and Final Evaluation (Week 12)
Survey question: Think back on the last 2 weeks; how many times have you experienced stoma effluent leakage outside the baseplate (e.g. onto clothes or bedsheets)?
次要结局
- Patient Self-management(Baseline (Day 0) and Final Evaluation (Week 12))
- Ostomy Leakage Impact Tool - 'Coping and in Control' Domain(Baseline (Day 0) and Final Evaluation (Week 12))
- Health Related Quality of Life(Baseline (Day 0) and Final Evaluation (Week 12))
- Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain(Baseline (Day 0) and Final Evaluation (Week 12))
- EQ-5D-5L Visual Analogue Scale (VAS)(Baseline (Day 0) and Final Evaluation (Week 12))
- Ostomy Leakage Impact Tool - 'Emotional Impact' Domain(Baseline (Day 0) and Final Evaluation (Week 12))