jRCT2052210214已完成不适用
A clinical trial of dried allogeneic cultured epidermis (Allo-JaCE03) for deep dermal burn
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 8age old over 至 75age old under（—）
- 性别
- All
入选标准
- •Patients with deep dermal burn (DDB) wounds of 40 cm^2 or larger
- •Patients with an age of >=8 years and =< 75 years when signed and dated informed consent, who can sign the informed consent forms by themselves, and whose legal representative can sign the informed consent if the patient is underage
排除标准
- •Patients with 20%TBSA or more of burn area
- •Patients with airway burns or soft tissue damage, patients caused by electric shock, etc., who determined by the investigator difficult to participate in the study.
- •Patients diagnosed underlying diseases such as diabetes, heart failure, liver failure, renal failure, neurological disease, or patients with systemic administrations of immunosuppressants or steroids (corticosteroids) , which may have potential interference in the wound healing.
- •Patients requiring sedation management
- •Patients with malignant cutaneous tumors, patients with suspected malignant cutaneous tumors or patients with a history of malignant cutaneous tumors in 5 years
- •Patients with hypersensitivity to antibiotics such as penicillin, kanamycin, streptomycin and amphotericin B. Patients who have a history of hypersensitivity to penicillin antibiotics and aminoglycoside antibiotics.
- •Patients with allergy to animals (bovine, mouse, pig)
- •Pregnant women, lactating women and patients who may possibly be pregnant or who have preference for pregnancy during the study period
- •Patients participated in other clinical trials or clinical researches in 4 months at the time of eligibility confirmation.
- •Patients participating in other clinical trials or clinical researches at the time of consent acquisition and patients planning to participate in other clinical trials or clinical researches during the study participation.
- •Patients determined by the investigator difficult to participate in the study.
结局指标
主要结局
-
Epithelialization rate of Allo-JaCE03 application site on 7th day after the initial application
次要结局
- Epithelialization rate of Allo-JaCE03 application site(14th and 21st day after the initial application)
- Subject ratio of complete epithlialization(21st day after the initial application)
- Wound condition
- Pain assessment
研究者
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