EUCTR2017-002460-41-IT进行中（未招募）1 期
A Phase IIb, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for the treatment of partial deep dermal and full thickness burns in adults in comparison to autologous split-thickness skin grafts (STSG)
niversity of Zurich, Tissue Biology Research Unit0 个研究点目标入组 12 人开始时间: 2019年12月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Age: =18 years of age
- •? Deep partial thickness and/or full-thickness burns requiring
- •surgical wound coverage
- •? The following two criteria must be met:
- •- Expected that =90cm2 of wound (not counting the head
- •and neck area for study patients in The Netherlands) will
- •remain open at 4 weeks post burn despite proceeding with
- •treatment in accordance with the standard of care,
- •- >25% TBSA burn
- •? Signed Informed consent from the patient or the legally authorized
- •representative.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •? Patients tested positive for HBV, HCV, syphilis or HIV
- •? Patients with known underlying or concomitant medical conditions
- •that may interfere with normal wound healing (e.g. systemic skin
- •and connective tissue diseases, any kind of congenital defect of
- •metabolism including insulin-dependent diabetes mellitus,
- •Cushing syndrome or disease, scurvy, chronic hypothyroidism,
- •congenital or acquired immunosuppressive condition, chronic
- •renal failure, or chronic hepatic dysfunction (Child-Pugh class B or
- •C), severe malnutrition, or other concomitant illness which, in the
- •opinion of the Investigator, has the potential to significantly delay
- •wound healing)
- •? Severe drug and alcohol abuse
- •? Pre-existing coagulation disorders as defined by INR outside its
- •normal value, PTT >ULN and fibrinogen hospital admission and / or at the Investigator’s discretion
- •? Patients allergic to amphotericin B and gentamicin
- •? Previous enrolment of the patient into the current phase II study
- •? Participation of the patient in another study with conflicting
- •endpoints within 30 days preceding and during the present study
- •? Patients expected not to comply with the study protocol (including
- •patients with severe cognitive dysfunction/impairment and severe
- •psychiatric disorders)
- •? Pregnant or breast feeding females
- •? Intention to become pregnant during the clinical course of the
- •study (12 months)
- •? Wounds in the head and neck area as study target area (only
- •applicable for study patients in The Netherlands)
- •? Enrolment of the Investigator, his/her family members, employees
- •and other dependent persons
研究者
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