NCT07034014招募中不适用
A Healthy Volunteer, Single Center, Exploratory Investigation to Evaluate Wearing Properties of Three Different Non-sterile Silicone Self-adhesive Investigational Devices
Molnlycke Health Care AB1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年6月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Evaluate stay-on-ability of the test specimens compared to the test specimen reference
研究概览
简要总结
This clinical investigation will assess the self-adhesive properties of two investigational devices compared to a test specimen reference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are capable and willing to comply with protocol visits, assessments, and instructions.
- •Participants must be in general good health with healthy and intact skin in the test area (as determined by the investigator based on medical history and examination of the application sites).
- •Minimal hairiness at the back (location of the application sites).
- •Signed written informed consent.
排除标准
- •Known allergy/hypersensitivity to the dressing or its components.
- •Participants with any features at the application sites will be in contact with the adhesive surface of the dressing, and could influence the investigation.
- •Participants not willing to avoid contact of the application sites with water in the morning prior to dressing application and throughout the entire course of the study.
- •Participants not willing to avoid applying any detergents to the application sites in the morning prior to dressing application and throughout the entire course of the study.
- •Participants not willing to avoid the use of leave on cosmetics such as creams/lotions and sunscreens at the application sites 3 days leading up to dressing application and throughout the entire course of the study.
- •Participants not willing to refrain from activities which may directly affect the dressings, application sites or assessments in the morning prior to dressing application and throughout the entire course of the study.
- •Participants whose back is not large enough to accommodate all 12 application sites
- •Any severe systemic disease that may interfere with the performance, evaluation, and outcome of the investigation as judged by the investigator.
- •Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
- •Active skin disease at the application sites .
- •Any topical medication at the application sites within the last 24 hours prior to the start of the test and/or throughout the entire course of the investigation.
- •Pain relief medication on assessment visits . If it is essential for the participant to take pain relief medication on the days mentioned above for any unforeseen reasons, the participant is allowed to use pain relief medication but has to report this to the study center in order to be documented as protocol deviation.
- •Pregnancy or lactation.
- •Drug addicts, alcoholics.
- •AIDS, HIV-positive or infectious hepatitis.
- •Individuals who are inmates in psychiatric wards, prison or state institutions, or any individuals otherwise regarded as vulnerable (as per ISO 14155 Section 3.55).
- •Participation in another investigative drug or device study currently or within the last 30 days.
- •Current participation in a cosmetic study.
- •Employees of the investigation sites directly involved in this clinical investigation.
- •Employees of the sponsor's company.
- •Employees of a competitor company. The participant should not work for any company which produces dressings.
- •The participant is considered by the Investigator to be unsuitable to participate in the investigation for any other reason
研究组 & 干预措施
12 dressings applied to designated sites on healthy volunteer participants
Other
The investigation will evaluate the dressing and the application regimen.
干预措施: Dressing (Device)
结局指标
主要结局
Evaluate stay-on-ability of the test specimens compared to the test specimen reference
时间窗: From enrollment to end of follow-up at day 14.
The percentage detachment of each test specimen and the test specimen reference will be assessed using a counting grid method. A standardized grid-patterned template will be applied to the application area to objectively quantify the area of detachment. The result will be expressed as a percentage of the total surface area in terms of the mean % detachment at Day 14. Unit of Measure: Percentage (%)
次要结局
未报告次要终点
研究者
研究点 (1)
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