NCT05902182尚未招募不适用
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Post Market Clinical Follow up Study to Demonstrate the Efficacy and Safety of Convatec ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive Dressings to Protect Against Skin Breakdown
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 主要终点
- To measure the efficacy of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect of skin against breakdown.
研究概览
简要总结
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive to protect against skin breakdown
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients aged 18 years and over
- •Patients able and willing to provide informed consent/Personal Consultee/Nominated consultee/ Their nominated consultee
- •Intact healthy skin
- •Stage I pressure ulcer/injury
- •Patients who are at risk of developing skin breakdown (injury), in any clinical setting, with at least one clinically vulnerable area (including but not limited to sacrum, heel, elbows, hips, ischial tuberosity and spine)
- •Braden score of 12 or less
排除标准
- •Patients with known allergies to any of the materials used in the dressing
- •Subjects requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutions
- •Patients who are at high risk of unavoidable skin breakdown for example caused by a medical device (for example, under ventilation or faecal management systems)
- •Patients with a wound of any aetiology on the area under investigation Patients who, in the opinion of the investigator, are considered unsuitable for any other reason
- •Patients with a history of previous healed pressure ulcer/ injury in the area under investigation
- •Patients who demonstrate a deterioration of skin from baseline skin assessment
结局指标
主要结局
To measure the efficacy of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect of skin against breakdown.
时间窗: 2 weeks
This will be measured by: • The incidence of skin breakdown
次要结局
- To assess the performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect skin against breakdown.(2 weeks)
- To assess the safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect skin against breakdown.(2 weeks)
研究者
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