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临床试验/NCT01350713
NCT01350713Unknown不适用

Testing the Counter-irritating Efficacy of Topical Povidone-iodine in Thermal Burns; Comparison to Conventional Treatments

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
280
试验地点
1
主要终点
prevention of skin lesions caused by exposure to heat source

研究概览

简要总结

Skin burns are one of the causes of disability, suffering and death in humans. Anecdotal, uncontrolled studies have shown the efficacy of povidone-iodine ointment in human skin burns, provided the preparation was applied shortly after the exposure to the heat source. The proposed study will conduct a controlled study in which the effect of povidone-iodine ointment will be tested in large group of patients and will be compared with standard cold water treatment.

详细描述

Skin burns are one of the causes of disability, suffering and death in humans. The current treatment includes application of cold water or other plant origin preparations. However non of these treatments was shown to be efficacious.

Animal studies have demonstrated the pronounced protective effect of povidone-iodine ointment against thermal burns. Moreover, anecdotal, uncontrolled studies in humans have shown the efficacy of povidone-iodine ointment in human skin burns, provided the preparation was applied shortly after the exposure to the heat source. The proposed study will conduct a controlled study in which the effect of povidone-iodine ointment will be tested in large group of patients and will be compared with standard cold water treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • skin burns in children

排除标准

  • allergy to iodine

研究组 & 干预措施

povidone iodine

Experimental

干预措施: povidone iodine (Drug)

cold water

Active Comparator

treatment by cold water after burn

干预措施: povidone iodine (Drug)

结局指标

主要结局

prevention of skin lesions caused by exposure to heat source

时间窗: 1 year

Skin exposed to hot liquid or metal that topically treated with povidone-iodine will show no or slight irritation while individuals treated with the standard cold water will show strong skin irritation including erythema and blisters.

次要结局

  • scar prevention(1 year)

研究者

申办方类型
Other

研究点 (1)

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