An Open Non-controlled Proof of Concept Investigation Evaluating the Handling of a Soft Silicone Wound Contact Layer, Mepitel® One Used in Acute Wounds in Home Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- to evaluate the handling of Mepitel® One when used in acute wounds in home care.
研究概览
简要总结
The primary objective is to evaluate the handling of Mepitel® One when used in acute wounds in home care.
Secondary objective is to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events.
详细描述
The investigation is designed as an open, non-controlled, proof of concept investigation. Subjects with acute wounds at one centre will be included. Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier. All dressing changes will be done according to clinical routine and registered in a dressing log. Cover dressing will be used when needed according to clinical routine.
A total of 10 subjects will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and have signed and dated the written informed consent.
The subjects will be consecutively allocated to a subject code.
At baseline, subject characteristics will be registered together with subject status of health, wound history and wound status, wound characteristics and current treatment of the wound.
The following variables will be measured as follows:
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
- •Acute wounds/burns
- •Male or female, 18 years and above, both in- and outpatients.
- •Signed Informed Consent Form
排除标准
- •Wound size above 21x24.5 cm
- •Subject not expected to follow the investigation procedures
- •Subjects previously included in this investigation
- •Subjects included in other ongoing clinical investigation at present or during the past 30 days
结局指标
主要结局
to evaluate the handling of Mepitel® One when used in acute wounds in home care.
时间窗: once a week for 3 weeks or until healing
次要结局
- to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events.(once a week for 3 weeks or until healing)