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OpenTrials
Completed

NCT Number: NCT05515146

Lymphovascular Abnormalities Under Tattoos

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.

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Key information

Conditions

Tattoo

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pierre Bourgeois

Paliseul, 6850, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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);
  • Pregnancy;
  • 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

Treatment and study plan

near infra red fluorescence lymphatic imaging

Diagnostic Test

ICG (0.2 ml from 25mg of ICG diluted by 5.0 ml of aqua ad injectabilia) was injected intradermally at the basis of the tattooed cutaneous area and at one point chosen so that the tracer had to flow under this area directly towards the root of the limb

Primary outcomes

  1. normal or abnormal lympho-vascular drainage

    Time frame: imagings were performed directly after the injection (duration 3 minutes)

    The following pictures were considered as normal

    • lymphatic vessels are well seen and drainage is fast spontaneously

  2. normal or abnormal lympho-vascular drainage

    Time frame: imagings were performed directly after the stretching and massages (duration 3 minutes)

    The following pictures were considered as normal

    • lymphatic vessels are well seen after stretching and massages of the injected site

  3. normal or abnormal lympho-vascular drainage

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Haute Ecole Bruxelles-Brabant

Other

Registry information

Official study title

Lymphovascular Abnormalities Under Tattoos : Preliminary Reports of One Observational Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2022
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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