Lymphovascular Abnormalities Under Tattoos

NCT ID: NCT05515146

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Tattoo

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

near infra red fluorescence lymphatic imaging

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. History of iodine allergy or anaphylactic reactions to insect bites or medication;

2. Hyperthyroidism;

3. Severe cardiac or pulmonary disease;

4. Significant renal failure (creatinine > 400 μmol/l);

5. Pregnancy;

6. any known disease of the skin (such as psoriasis);

7. any disease known to affect the cutaneous tissues (such as diabetes);

8. any previous operation and/or trauma at the level of tattooed limb;

9. familial history of lower limb edemas:

10. skin infection after the tattoo

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haute Ecole Bruxelles-Brabant

OTHER

Sponsor Role: lead

Responsible Party

Bourgeois Pierre

Prof Dr P Bourgeois

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pierre Bourgeois

Paliseul, , Belgium

Countries

Belgium

Other Identifiers

HE2BHERSICGTT

Identifier Type: -

Identifier Source: org_study_id