CTRI/2019/04/018804已完成不适用
Comparison Of The Efficacy Of Autologous Non- Cultured Melanocyte – Keratinocyte Cell Suspension With Split Skin Grafting On Adequate Re-pigmentation Of Post Burn Leukoderma: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- JIPMER
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Repigmentation
研究概览
简要总结
The purpose of this study is to identify the efficacy of autologous non cultured melanocyte keratinocyte cell suspension in relation to the standard care of split skin grafting in patients with post burn leucoderma patches Research Hypothesis: Autologous non-cultured melanocyte keratinocyte cell suspension is more effective in producing adequate re-pigmentation than split skin grafting in post burn leukoderma at 3 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All patient with post burn leukoderma who attend the JIPMER plastic surgery outpatient department Age more than 12 years.
排除标准
- •i.Any previous surgical treatments for post burn leukoderma in the past 1 year ii.Patients with ulcers over the hypopigmented patches iii.Patients with keloid tendency iv.Patients with autoimmune diseases.
结局指标
主要结局
Repigmentation
时间窗: 3 months
Graded based on the percentage of repigmentation of the treated areas as follow
时间窗: 3 months
Excellent - 90-100% pigmentation,
时间窗: 3 months
Good - 50-89%,
时间窗: 3 months
Fair - 20-49%
时间窗: 3 months
Poor - 0-20%
时间窗: 3 months
次要结局
- Patient satisfaction(3months)
研究者
研究点 (1)
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