NCT02237118已完成不适用
Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"
Molnlycke Health Care AB1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2014年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)
研究概览
简要总结
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 wound: traumatic wound (dermabrasion, skin tears, other), benign burn requiring the use of dressings
- •Acute wound size between 3 cm² and 240 cm2 (wound could be covered by 2 investigational products maximum)
- •Wound whose duration is ≤ 3 days
- •Both gender with an age ≥ 18 years
- •Subject able to understand and voluntarily sign the informed consent
- •Subject able to follow the protocol
- •Subject insured to the French social security system
排除标准
- •Surgical wound
- •Infected, moderately to strongly exudative and haemorrhagic wound
- •Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, ...) which, as judged by the investigator, could interfere with the pain assessment
- •Known allergy/hypersensitivity to any of the components of the investigational products
- •Participation in other clinical investigation within one month prior to start of investigation
- •Pregnant or breast-feeding women
- •Person protected by a legal regime (tutorship or guardianship)
研究组 & 干预措施
UrgoTul
Active Comparator
Pain on removal by VAS
干预措施: Mepitel One (Device)
UrgoTul
Active Comparator
Pain on removal by VAS
干预措施: UrgoTul (Device)
Mepitel One
Active Comparator
Pain on dressing removal, by VAS
干预措施: Mepitel One (Device)
Mepitel One
Active Comparator
Pain on dressing removal, by VAS
干预措施: UrgoTul (Device)
结局指标
主要结局
Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)
时间窗: 21 days
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.
次要结局
- Assessment of the Surrounding Skin.(21 days)
- Condition of the Wound, Will be Assesst by the Investigator.(21 days)
- Safety(21 days)
- Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.(21 days)
研究者
研究点 (1)
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SPOKE trialspoke injuries, bicycle spoke injuries, wound,NL-OMON24131Wintermans, S., Noordwest ziekenhuisgroepWilhelminalaan 121815 JD Alkmaars.wintermans@nwz.nl 072 - 548 4444108