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临床试验/NCT05515146
NCT05515146已完成不适用

Lymphovascular Abnormalities Under Tattoos : Preliminary Reports of One Observational Study

Haute Ecole Bruxelles-Brabant1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
normal or abnormal lympho-vascular drainage

研究概览

简要总结

The number of tattooed people is increasing and some complications secondary to tattoos suggest that the lymphatic vascular system might be implicated in their pathogenesis. Abnormalities have been described at the level of the lymph nodes draining the tattooed areas but nothing was reported about the lymphatic vessels under tattoos. This is the aim of the present work.

详细描述

19 subjects with 20 tattooed skin surfaces were enrolled after written informed consent and the lymphvascular drainage under the tattooed surface was studied using one near infrared camera device after one intradermal injection of Indocyanine Green.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • presence of one tattoo at the level of one limb
  • written informed consent

排除标准

  • History of iodine allergy or anaphylactic reactions to insect bites or medication;
  • Hyperthyroidism;
  • Severe cardiac or pulmonary disease;
  • Significant renal failure (creatinine > 400 μmol/l);
  • any known disease of the skin (such as psoriasis);
  • any disease known to affect the cutaneous tissues (such as diabetes);
  • any previous operation and/or trauma at the level of tattooed limb;
  • familial history of lower limb edemas:
  • skin infection after the tattoo

结局指标

主要结局

normal or abnormal lympho-vascular drainage

时间窗: imagings were performed after a period of normal activities (duration 30 minutes)

The following pictures were considered as normal - lymphatic vessels are well seen after 30 minutes of normal activities and direct between the injected site and-towards the first lymph node at the root of the limb

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bourgeois Pierre

Prof Dr P Bourgeois

Haute Ecole Bruxelles-Brabant

研究点 (1)

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