跳至主要内容
临床试验/NCT02356354
NCT02356354终止不适用

Study of the Cutaneous Reinnervation After Burn With the Aim of a Better Care of Neuropathic Pain and Pruritus After Healing

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
2
主要终点
Number of the differences of expression of genes coding for regulating proteins of the innervation

研究概览

简要总结

The aim of this study is to understand why the regeneration of the cutaneous sensory nerve fibers is poor in post-burn scar.

The presence or the lack of several molecular factors known to regulate neuronal cell development will be evaluate and compared within biopsies from healthy skin and post-burn scar.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major patients
  • At least one year back deep burn (2nd and 3rd degrees), and allowing the comparison between the post-burn scar dermatome and the healthy opposite dermatome
  • Patients always followed in the service of Plastic surgery of the hospital of Brest
  • Informed consent and paper of the patient after information of the objective of the study and the protocol
  • Analog Visual scales for pain and/or pruritus (EVA): greater than or equal to 3
  • Simple Verbal scales for the pain and/or the pruritus ( EVS): pain / pruritus moderated to intense
  • Membership to the Social Security

排除标准

  • Allergy to xylocaine
  • Non-Caucasian patients
  • Treatments having an effect on the pain and/or the pruritus
  • Sun or UV exposure several days preceding or following the biopsies

结局指标

主要结局

Number of the differences of expression of genes coding for regulating proteins of the innervation

时间窗: 6 months

To evaluate the differences of expression of genes coding for regulating proteins of the innervation on samples of healthy skins and post-burn scar. These biopsies will be removed from post-burn patients (at least one year after burn) and allowing the comparison between conflicting dermatomes: a healthy dermatome and a formerly burned dermatome

次要结局

  • Validation of the difference of density of intra-epidermic nerve fibers(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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