NL-OMON56452招募中2 期
A Phase II, 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 full thickness skin defects in adults and children in comparison to autologous split-thickness skin grafts (STSG) - TBRU-dS-RAC-PII
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- CUTISS AG
- 入组人数
- 8
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
- 2 至 99（—）
入选标准
- •Age: >=1 year of age
- •Large full-thickness defects that require coverage after excision of:
- •-Benign skin tumors (e.g. neurofibroma)
- •-Melanocytic nevus (e.g. giant nevus)
- •- Gender reassignment surgery
- •-Soft tissue defect after trauma
- •-Soft tissue defect after infection and debridement (e.g. necrotizing fascitis,
- •hidradentitis suppurativa, purpura fulminans)
- •-Flap donor site (e.g. radial forearm flap)
- •Minimal areas requiring coverage (not counting the head and neck area for
- •study patients in The Netherlands):
- •-Minimum: 1-5 years: 9 cm2
- •- Minimum: 6-16 years: 25 cm2
- •-Minimum: > 16 years: 45 cm2
- •Signed informed consent from the patient or the parents/legally authorized
- •representative.
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
研究者
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