NL-OMON41095已完成2 期
EuroSkinGraft - Novomaix phase II A phase 2, intra-patient randomised controlled multicentre international study to evaluate the efficacy of an acellular dermal template Novomaix for the treatment of full thickness skin defects. - Euroskingraft - Novomaix phase II
niversity of Zurich - Tissue Biology Research Unit0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Competent and temporarily incompetent patients age > = 18 years with full thickness skin defects that require skin grafting AND
- •- Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm AND
- •- <= 50% TBSA (total body surface area) full thickness skin defects at time of intervention AND
- •- Informed consent by the patient and/or legal representatives.
排除标准
- •When any of the following criteria are met, the potential subject will be excluded from participation in this study:
- •- Patients with infected wounds
- •- Full thickness skin wounds located in face and/or genitals will not be included
- •- Pregnant or breast feeding females
- •- Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, uncontrolled diabetes, treatment with corticoid therapy, collagenoses, cancer)
- •- Known allergy against porcine collagen or elastin
- •- Patients that are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
- •- Previous enrolment of the patient into the current study
研究者
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