NCT00978705Unknown3 期
Clinical Study for Evaluation of Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- engraftment assessment
研究概览
简要总结
The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 1~70 years
- •More than 30% TBSA of second degree burn or more than 10% TBSA of third degree burn
- •Must provide signed informed consent prior to participation in any study-related procedures
排除标准
- •Have a pyogenic infection
- •Part of the facial cosmetic surgery cost
- •Hypersensitivity reactions in patients with bovine proteins
- •Hypersensitivity reactions in patients with Gentamycin
- •Pregnancy or lactation
结局指标
主要结局
engraftment assessment
时间窗: 4week
次要结局
- the vancouver burn scar scale(8, 12, 24 week)
研究者
研究点 (1)
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Treatment of Patients With Skin Burns Using Keratinocytes and Skin FibroblastsBurnsNCT04485962Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus12
进行中（未招募）
1 期
Application of cultured autologous keratinocytes in combination with a meshed split skin autograft for burn wound healing - Cultured keratinocytes for burn wound treatmentEven standard treatment, transplantation with a (meshed) split skin autograft, does not result in satisfactory functional and cosmetic appearance of the healed wound. Due to limited available donor sites meshes needs to be enlarged. Bigger enlargements of meshes give more scarring and mesh pattern are still visible in scars, probably because wound closure still needs several weeks. Application of cultured autologous keratinocytes may enhance wound closure.MedDRA version: 9.1Level: LLTClassification code 10006795Term: Burns extensiveEUCTR2007-004296-19-NLAssociation of Dutch Burn Centres