EUCTR2017-002461-21-NL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 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
- 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: <12 years of age
- •Deep partial thickness and/or full thickness burns requiring surgical wound coverage
- •Expected that =90cm2 of wound will remain open at 4 weeks post burn despite proceeding with treatment in accordance with the standard of care, >20% TBSA burns can be taken as guideline, but TBSA is not an inclusion criterion.
- •Signed Informed onsent from the patient or the parents/legally authorized representative.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 parents/legal guardian expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
- •Pregnant or breast feeding females
- •Suspicion of non-accidental injury
- •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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