A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Mean Adherent Area Measured by Photo of Used Tape
研究概览
简要总结
An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
详细描述
The test products are non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •Be at least 18 years of age and have full legal capacity
- •Have had a stoma for more than ½ year
- •Have intact skin on the area used in the study (Assessed by investigator, see Appendix 1).
- •Willing to change baseplate every second day or less frequent
- •Willing to avoid using Concave baseplate during the study.
- •Willing to avoid the use of barrier creams or similar that affect the skin/adhesive interface under the tape.
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 peristomal skin area or systemic steroid (tablet(injection) treatment
- •Is pregnant or breastfeeding
- •Having dermatological problems in the peristomal area (assessed by investigator)
结局指标
主要结局
Mean Adherent Area Measured by Photo of Used Tape
时间窗: Tapestrips per test product were removed from the baseplate at each product change and saved for the next site visit every 7-9 days for evaluation
The adherent area (cm2) measured per baseplate change after use shows how effectively the ostomy tape adheres to the skin. After removal of the ostomy tape, a photo of the tape was taken. The adherent area was measured from the photo and an image analysing program.
次要结局
- Erythema Measured After Tape Removal by Photos(The measurements were carried out after 7-9 days of treatment with the test tape)
- Erythema Measured After Each Treatment Period by Spectrophotometric Method(The measurements were carried out after 7-9 days of treatment with the test tape)
- Feeling of Security(The evaluation was carried out after 7-9 days of treatment with the test tape)
- Comfort(The evaluation was carried out after 7-9 days of treatment with the test tape)
- Skin Issues in the Area Covered by the Tape(The evaluation was carried out after 7-9 days of treatment with the test tape)
- Adverse Events(27 days)
- Adhesion of Tape(The evaluation was carried out after 7-9 days of treatment with the test tape)