An Open-label, Prospective, Comparative Human Participant Study to Evaluate the Clinically Acceptable Dressing Presence and Conformability Properties of a Prototype Multilayer Foam Dressing in Comparison to ALLEVYN◊ LIFE and Another Established Medical Device.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Acceptable Dressing Presence at Day 7
研究概览
简要总结
The purpose of this study is to evaluate a new prototype multilayer foam dressing on healthy, intact skin.
The study will find out how well the new prototype dressing stays in place as well as other dressing performance and safety factors when compared to two corresponding, marketed dressings with a similar intended use profile and shape.
The study will compare:
- Prototype dressing vs Marketed dressing 1 on thighs and shins.
- Prototype dressing vs Marketed dressing 2 on thighs and shins.
The main aim of the study is to show that the new prototype dressing is not worse than the established marketed comparison dressings in terms of staying in place on human participants at 7 days.
Dressings will have successfully stayed in place if the dressing edges have not lifted to reach the pad, and the pad is not exposed in any way.
Additional data will be collected to further support product performance up to 7 days, including safety information and potential device issues.
详细描述
This is a single-center prospective, open-label, comparative, interventional study with intra-individual comparison.
Each participant will receive four dressings (two prototype dressings and one of each comparator Marketed dressings). The dressings will be randomized to either the left or right thigh/shin in a 1:1 ratio. Primary analyses will be performed on the following comparison pairs:
- Prototype dressing vs Marketed dressing 1 on thighs and shins
- Prototype dressing vs Marketed dressing 2 on thighs and shins
120 participants will be recruited into this study at a single, Germany-based site. The sample size accounts for the required 105 evaluable participants and approximately 10% lost to follow-up rate. Participants will be in good general health and have intact skin.
Duration of the study will be 7-14 days, with participants attending 5 site visits. Screening can be completed on Day 0 or at a separate visit up to 7 days prior to Day 0. Dressings will be worn by participants for up to 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Participant is capable of providing informed consent
- •Participant is willing and able to make all required study visits
- •Aged 18-70 years at the time of signing the informed consent*
- •Participant must be in good health, as determined by the Investigator, based on medical evaluation, including medical history and skin application site assessment (healthy intact skin at or near any of the dressing application sites)
- •Participant is willing not to use cosmetic or medicinal lotions, creams, ointments and anything else which may interfere with dressing adhesion at dressing application sites for the duration of the study from 24 hours before dressing application on Day
- •Participant is willing to have excess hair removed from the dressing application sites
- •Participant is willing to avoid immersing the dressings in water (no swimming or bathing) for the duration of the study
- •[*at least 10% of participants are aged >55 years]
排除标准
- •Female participant who is pregnant, or lactating.
- •Participant has a known sensitivity to any of the study products, materials or ancillary product or components.
- •Known skin sensitivity or allergies to adhesives, skin wipes, soap, surgical first-aid dressings, natural rubber or rubber latex, etc.
- •Participants with a current active skin disease (e.g., eczema, psoriasis, or severe dermatoporosis), sunburn or skin peeling at the dressing application sites.
- •Participants with a medical condition which may interfere with their perception of pain (such as diabetes, small-fibre neuropathy, allodynia, hyperalgesia etc.).
- •Heavy smokers (e.g. >20 cigarettes (~1 pack) a day over the last 10 years) whose pain perception may have been affected through smoking.
- •Participants with any skin features near any of the dressing application sites that could be identifiable/may interfere with skin assessments (e.g. tattoos/distinctive markings or scars/keloids).
- •Participants diagnosed with hyperhidrosis or who self-report their normal sweating level to be severe as determined by the Sweating Severity Self-Assessment (SSSA) at screening (e.g. mild, moderate, severe).
- •Participants not willing to refrain from the use of pain relief medication on assessment days (1, 3 and 7) and in the case of certain medications, 24 hours before assessments.
- •Participants unwilling to refrain from activities which may directly affect the dressing, dressing application sites or assessments (such as undergoing planned scanning procedures, e.g., X-ray, magnetic resonance imaging (MRI) and computed tomography (CT) scanning; exposure to airport scanners or devices emitting radio waves; exposure to atypical conditions of pressure, humidity and temperature; immersing the dressing in water e.g. bathing / swimming / cleaning the dressing application sites; using a sauna; undertaking strenuous physical activity like aerobics, running, cycling, heavy labor etc.; using lotions/creams/ointments etc. at the dressing application sites; excessively exposing the dressing application sites to the sun (e.g. sunbathing for >1 hour); wearing tightly fitting clothes which could affect the dressings.
- •Individuals who have participated in a clinical study in the last 7 days, using the same dressing application sites.
- •Participants with poor compliance and / or poor willingness to co-operate.
- •Individuals who should not participate in the clinical investigation for any other reason (including the taking of certain medications) as judged by the Investigator.
- •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).
- •Employees of the investigation sites directly involved in this clinical investigation or employees of the sponsor's company.
研究组 & 干预措施
Prototype dressing vs Marketed dressing 1
The participant will be randomised to receive the comparison pair Prototype dressing vs Marketed dressing 1 on the left or right thigh/shin in a 1:1 ratio.
干预措施: Prototype dressing (Device)
Prototype dressing vs Marketed dressing 1
The participant will be randomised to receive the comparison pair Prototype dressing vs Marketed dressing 1 on the left or right thigh/shin in a 1:1 ratio.
干预措施: Marketed dressing 1 (Device)
Prototype dressing vs Marketed dressing 2
The participant will be randomised to receive the comparison pair Prototype dressing vs Marketed dressing 2 on the left or right thigh/shin in a 1:1 ratio.
干预措施: Prototype dressing (Device)
Prototype dressing vs Marketed dressing 2
The participant will be randomised to receive the comparison pair Prototype dressing vs Marketed dressing 2 on the left or right thigh/shin in a 1:1 ratio.
干预措施: Marketed dressing 2 (Device)
结局指标
主要结局
Acceptable Dressing Presence at Day 7
时间窗: Day 7
Count of dressings with acceptable dressing presence was determined by a yes/no assessment at Day 7, with a 'yes' response defined as the dressing is in place with no border lift reaching the pad and no pad exposure.
次要结局
- Presence of Dressing(Day 1, Day 3 and Day 7)
- Pad Lift(Day 1, Day 3 and Day 7)
- Dressing Comfort(Day 1, Day 3 and Day 7)
- Acceptable Dressing Presence at Day 1 and Day 3(Day 1 and Day 3)
- Pad Integrity(Day 1, Day 3 and Day 7)
- Border Lift(Day 1, Day 3 and Day 7)