NCT01917591已完成不适用
Healing of Punch Graft Wounds With Two Biologic Exracellular Matrices; a Non-inferiority Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kerecis Ltd.
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- wound healing
研究概览
简要总结
The objective is to determine, if healing of punch biopsy wounds treated with the fish skin derived MariGen Wound dressing is non-inferior to healing with wounds treated with pig intestines derived Oasis Sheet wound dressing. Secondary endpoints are: Incidence of erythema, Pain, Infection, Quantitative measurements of autoantibodies at baseline and 4 weeks after start of treatment
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individual
- •Signature of informed consent
排除标准
- •Autoimmune disease
- •Immunosuppressive treatment
- •Use of addictive drugs
- •Excessive use of alcohol
- •Known fish allergy
- •Known allergy to proteins with porcine origin
- •Peripheral vascular disease
- •Pregnant women
- •Persons receiving anticoagulation therapy or systemic corticosteroids will be excluded.
研究组 & 干预措施
MariGen Wound
Active Comparator
Fish derived extra cellular matrix
干预措施: Punch biopsies treated with MariGen Wound ECM dressing (Device)
Oasis Sheet
Active Comparator
Pig intestine derived extra cellular matrix
干预措施: Punch biopsies treated with Oasis ECM dressing (Device)
结局指标
主要结局
wound healing
时间窗: 28 days
Time to epithelialisation
次要结局
- Pain at wound site(28 days)
- Infection(28 days)
- Autoimmune investigations(28 days)
- Incidence of erythema(28 days)
研究者
研究点 (1)
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