Controlled Randomized Study With a New Base Plate Versus SenSura Base Plate on Perspiring Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Visual Inspection of Baseplate Loosening
研究概览
简要总结
Aim
The aim of the Athena project is to develop an ostomy product that is softer and more flexible in order to improve the comfort for people with a stoma.
The present investigation aims at testing how well the new Athena base plate adhere to perspiring skin both with and without mechanical exposure (cycling) since the ability to adhere under normal daily activity is an important quality for Coloplast products.
Success criteria:
The investigation is an explorative investigation where the adherence of Athena on perspiring skin is evaluated. Due to the explorative nature of the study it has not been possible to define specific success criteria up front. However, the adherence qualities of Athena may not be significantly reduced compared to SenSura.
Design:
Two groups of men, one group with a colostomy and one group without a colostomy, are included. The men should be cardiovascular fit, be able to cycle for 1 hour at moderate intensity and with Athena and SenSura base plates applied on the back and stomach. The adhesion of the base plates are tested before and after the physical activities.
Population:
The population consists of two groups. Group A: Men in the age of 50-70 without a stoma who have volunteered. Group B: Men with a colostomy who have volunteered. Both groups should be cardiovascular fit (cardio investigated), and be willing to cycle for 1 hour at moderate intensity on an exercise bike.
The Athena test products are non-CE marked, non-sterile, 1-piece ostomy products with a flat custom cut base plate, a closed bag size midi or maxi with the intended use of collecting faeces from the colostomy. The comparator product is a Coloplast SenSura, 1-piece ostomy product with a closed bag. SenSura is CE-marked and launched on the market.
详细描述
The aim of the Athena project is to develop an ostomy product, for people with a colostomy, with better comfort than other normal ostomy products. This has been attempted through development of a soft and flexible base plate that follows the contours of the body.
It is the aim of Coloplast to gain knowledge about whether the Athena base plate can adhere to peristomal skin to the same degree as the SenSura base plate in situations of perspiration both with and without mechanical exposure.
Primary endpoint Calculation of the area of the base plate that has detached from the skin. The area is based on a visual evaluation of Athena and SenSura adhesives measured on the skin of the stomach after 1 hour of cycling at moderate intensity.
Secondary endpoint(s)
- Registration of the weight of the adhesive after physical activity on the bike and after 1 hour in a warm room.
- Evaluation of the effects on the skin measured as number of skin cells on the adhesive after use.
- Loss of liquid.
- Peel test (tractive force) of the adhesive on the skin of the stomach (mechanical exposure and perspiration).
- Peel test (tractive force) of the adhesive on the skin of the back (perspiration without the mechanical exposure).
- Calculation of the area that has detached from the skin based on a visual evaluation of the adhesives on the skin of the back (perspiration without mechanical exposure).
- Mechanical evaluation of the area of the adhesive that no longer adhere to the skin on both the stomach and on the back.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Group A: Men without a stoma in the age of 50-70 years Group B: Men with a stoma
- •Inclusion criteria:
- •To be included in the investigation, the subjects in Group A must comply with the following selection criteria:
- •Have signed informed consent and letter of attorney
- •Be a man in the age of 50-70 years
- •Is capable of understanding the experiment
- •Have a BMI (body mass index) between 20-30 kg/m2
- •Is willing to test the adhesives from the two Coloplast products, Athena and SenSura
- •Is evaluated as suitable for inclusion according to cardiovascular test and fitness test performed at the screening
- •To be included in the investigation, the subjects in Group B must comply with the following selection criteria:
- •Have signed informed consent and letter of attorney
- •Be a man of at least 18 years of age
- •Have a colostomy with a max width of 45 mm and have had the colostomy for at least 3 months
- •Is capable of understanding the experiment
- •Have a BMI between 20-30 kg/m2
- •Is willing to test the adhesives from the two Coloplast products, Athena and SenSura
- •Is evaluated as suitable for inclusion according to cardiovascular test and fitness test performed at the screening
排除标准
- •Subjects who comply with the following criteria must be excluded from the investigation:
- •Have dermatological problems
- •Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- •Have elevated cholesterol levels, elevated blood pressure, diabetes or any form of cardiovascular disease.
- •Currently receiving or have within the last 3 weeks received local treatment with steroids (ointment or creme) on back or stomach*
- •Group A may not have a stoma
- •Group B may not use convex base plates * Radio- and chemotherapy can lead to changes in the skin and intestine. It is known that steroid can lead to fragile skin which can affect application and removal of the adhesive
结局指标
主要结局
Visual Inspection of Baseplate Loosening
时间窗: 1 hour
The area of the adhesive that was detached from the skin based on visual evaluation of the Athena and Sensura adhesives on the stomach after 1 hour of cycling at moderate intensity. The evaluation was done by marking the detached areas at the baseplate on a transparent wound tracing sheet with a permanent marker. Subsequently the areas were measured by scanning the tracing sheet and calculating the area with the use of Imagepro image macro which calculates the result in cm\^2
次要结局
未报告次要终点