Open, Prospective, Single Centre, Randomized, Controlled, Cross-over. Clinical Study Investigating the Correlation in Peel Force of Standard Hydrocolloid Adhesive and a Standard Strata Adhesive From Peristomal Skin and Pre-stripped Abdominal Skin in Colostomists
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Peel Force
研究概览
简要总结
The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin in colostomists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have given written informed consent.
- •Be in the age of 45 to 75 years of age both extremes included.
- •Have had a colostomy for at least 1 year.
- •Has a colostomy with a diameter up to (≤) 40 mm.
- •Have mental capacity to understand the study guidelines and questionnaires.
- •Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation.
- •Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
- •Have a BMI between 20-30 kg/m
- •Are willing to comply with investigation procedures.
排除标准
- •Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- •Received radio- and/or chemotherapy within the last two months.
- •Currently using or have within the last 3 weeks used topical steroid products or other skin prep products.
- •on peristomal skin (injections and oral treatment are accepted).
- •Have dermatological problems.
- •Participating in other clinical studies or have previously participated in this test.
- •Be a daily user of a convex base-plate.
- •Are pregnant or breastfeeding.
- •Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).
结局指标
主要结局
Peel Force
时间窗: 1 hour
The peel force was measured with a tensile tester which measured the force needed to remove the the adhesive strip from the skin with a constant speed 304mm/min and a mean angel of 90 degrees. The peel force was measured on all participants in the flow module. However, sometimes the measurements failed and therefore did not provide a result. In example a wheel chair user was included and non of peel force measurements were succesful on the subject. The rest of the failed measurements were distributed randomly between the subjects.
次要结局
未报告次要终点