NL-OMON55737尚未招募2 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) - TBRU-dS-BC-PIIb
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- CUTISS AG
- 入组人数
- 4
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
- 0 至 11（—）
入选标准
- •Age: <12 years of age
- •Deep partial thickness and/or full-thickness burns requiring surgical
- •wound coverage
- •Expected that >=90 cm2 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. >20% TBSA burns can be taken as guideline, but TBSA is not an
- •inclusion criterion.
- •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 / or at the Investigator*s discretion
- •Patients with known allergies to amphotericin B, gentamicin, penicillin or
- •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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