DRKS00010930已完成未知
Randomised controlled multicenter study to evaluate safety and performance of Geistlich Wound Matrix versus autologous skin graft in the treatment of skin defects
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Written informed consent
- •Age 18 years or older
- •Acute skin defect post surgical excision
- •Maximal size of skin defect 20 x 30 mm
- •Skin defect of at least 10 mm in diameter
- •Indication for transplantation of autologous skin graft
- •Healthy skin within 10 mm around the excision margin
- •Estimated life expectancy of > 1 year
排除标准
- •General contraindications for surgical treatments
- •Severe diseases (e.g. active carcinoma) upon decision of the investigator
- •Intention to perform flap surgery
- •Indication for secondary wound healing
- •Indication for primary wound closure (i.e. amount and quality of adjacent soft tissue sufficient to allow for appropriate wound closure by suturing)
- •Allergy to porcine collagen
- •Known allergy to adhesive bandage
- •Autoimmune disease
- •Uncontrolled metabolic diseases (e.g. diabetes, osteomalacia, thyroid disorder)
- •Previous or planned prolonged corticosteroid therapy
- •Insufficiently vascularized soft tissues due to heavy smoking
- •Skin defect at target site(s) smaller than 10 mm in diameter
- •Skin defect at target site(s) caused by burn or ulcer
- •Chronical wound at target site(s)
- •Local infection at target site(s)
- •Known collagenase disease
- •Previous or planned radiotherapy in the target area
- •Immunosuppressive therapy
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study
- •Vulnerable population
- •Women of childbearing age who are not using a highly effective method of birth control
- •Pregnant or breast feeding women
- •Participation in another study with investigational drug, biologics or device within the 26 weeks preceding the present study
- •Participation in another clinical study during the present study
研究者
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