EUCTR2017-002462-41-NL进行中（未招募）1 期
A Phase II, prospective, intra-patient randomized 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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CUTISS AG
- 入组人数
- 20
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: =1 year of age
- •Large full-thickness defects that require coverage after excision
- •o Benign skin tumors (e.g. neurofibroma)
- •o Melanocytic nevus (e.g. giant nevus)
- •o Gender reassignment surgery
- •o Soft tissue defect after trauma
- •o Soft tissue defect after infection and debridement (e.g.
- •necrotizing fascitis, hidradentitis suppurativa, purpura
- •o 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):
- •o Minimum: 1-5 years: 9 cm2
- •o Minimum: 6-16 years: 25 cm2
- •o Minimum: > 16 years: 45 cm2
- •Signed informed consent from the patient or the
- •parents/legally authorized representative.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) no
- •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 • Patients with known allergies to amphotericin B, gentamicin,
- •penicillin, streptomycin, or bovine collagen
- •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 or or parents/legally authorized representative 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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