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 Defects in Adults and Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CUTISS AG
- 入组人数
- 21
- 试验地点
- 13
- 主要终点
- Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
研究概览
简要总结
This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.
详细描述
This multicentre phase II clinical trial will target adults and children with fullt-thickness skin defects to elucidate the benefit of a tissue-engineered autologous skin substitute. Particular emphasis, apart from safety, will be placed on efficacy, e.g. scar quality, in comparison to meshed STSG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥1 years of age
- •Large full-thickness defects that require coverage after excision of: Scars, 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 necrotizingn fascitis, hidadentitis suppurativa, purpura fulminans), Flap donorsite (e.g. radial forearm flap)
- •Minimal areas requiring coverage (not counting the head and neck area for study patients in The Netherlands): 1-5 years: minimum 9cm2, 6-16 years: minimum 25cm2, >16 years: minimum 45cm2
- •Signed Informed consent
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 <LLN prior to the current hospital admission and / or at the Investigator's discretion
- •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 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)
- •Enrolment of the Investigator, his/her family members, employees and other dependent persons
研究组 & 干预措施
Option 1
Location A is the experimental area and Location B is the control area.
干预措施: EHSG-KF (Biological)
Option 2
Location A is the control area and Location B is the experimental area.
干预措施: EHSG-KF (Biological)
Option 1
Location A is the experimental area and Location B is the control area.
干预措施: STSG (Biological)
Option 2
Location A is the control area and Location B is the experimental area.
干预措施: STSG (Biological)
结局指标
主要结局
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
时间窗: 3 months post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality, using the POSAS ("Patient and Observer Scar Assessment Scale"). The reported Observer Total Score can range from 1 (best) to 10 (worst).
次要结局
- Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take.(4-11 days post grafting)
- Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate.(4-11 days and 19-23 days post grafting)
- Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.(1 +/- 30 days year post grafting)
- A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality(3 months and 1 year +/- 30 days post grafting)
- Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events.(through study completion, an average of 3 years)
- Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation(28 +/- 3 days post grafting)
- Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality(3 months and 1 year +/- 30 days post grafting)