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
- 1
- 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)
研究组 & 干预措施
Test product A new adhesive material
The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.
干预措施: Test product A (Device)
Test product A new adhesive material
The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.
干预措施: Test product B (Device)
Test product A new adhesive material
The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.
干预措施: Comparator (Device)
Test product B new adhesion material
The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.
干预措施: Test product A (Device)
Test product B new adhesion material
The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.
干预措施: Test product B (Device)
Test product B new adhesion material
The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.
干预措施: Comparator (Device)
Comparator
The comparator product is Brava Elastic tape which is already on the market and will be used within the in-tended use in this clinical investigation.
干预措施: Test product A (Device)
Comparator
The comparator product is Brava Elastic tape which is already on the market and will be used within the in-tended use in this clinical investigation.
干预措施: Test product B (Device)
Comparator
The comparator product is Brava Elastic tape which is already on the market and will be used within the in-tended use in this clinical investigation.
干预措施: Comparator (Device)
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)