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临床试验/RPCEC00000256
RPCEC00000256尚未招募2 期

Evaluation of the effect of Chitosan Unguent at 1% in the treatment of patients with first and second degree superficial burns

Center for Pharmaceutical Research and Development, Havana, Cuba.0 个研究点目标入组 40 人开始时间: 2017年10月16日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40

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
Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

入排标准

年龄范围
18 years 至 70 years(—)
性别
All

入选标准

  • 1- Cuban patients, of any sex, any skin color, with superficial burns, grades I and II.
  • 2- Ages between 18 and 70 years, both inclusive.
  • 3 - Burns by physical agents.
  • 4- Written informed consent of the patient to participate in the investigation and to complete the established examinations.

排除标准

  • 1- Burns from electrical or chemical origin, by inhalation or combined.
  • 2 - Presence of microbiologically confirmed sepsis in the lesions, caused by Pseudomonas aeruginosa or other bacterial agents.
  • 3- History of allergy or hypersensitivity to any component of the formulation.
  • 4- Diabetes mellitus.
  • 5- Referred immunological disease.
  • 6- Malignant disease.
  • 7- Collagen disease.
  • 8- Pregnancy, breastfeeding or puerperium.
  • 9- Severe psychiatric disorder or mental incapacity.

研究者

发起方
Center for Pharmaceutical Research and Development, Havana, Cuba.

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