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)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- CUTISS AG
- 入组人数
- 12
- 试验地点
- 8
- 主要终点
- Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface
研究概览
简要总结
This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in children with partial deep dermal and full thickness burns.
详细描述
This multicentre phase IIb clinical trial will target patients from 1-17 years with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. Particular emphasis, apart from safety, will be placed on efficacy, including the ratio of covered surface area to harvested surface area and 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
- 0 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
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
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
- •Patients with a known history of malignancy
- •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 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 child abuse
- •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
研究组 & 干预措施
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)
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: EHSG-KF (Biological)
结局指标
主要结局
Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface
时间窗: 4 weeks post grafting
Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface area to biopsy site/donor site surface area
次要结局
- Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by assessment of general scar quality using POSAS assessment tool(1 year +/-30 days post grafting)
- Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R)(1 year +/-30 days post grafting)
- Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection(4-11 days post grafting and 21 +/-2 days post grafting)
- Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection(4-11 days post grafting and 21 +/-2 days post grafting)