Lymphovascular Abnormalities Under Tattoos

Tattoo Clinical Trial

Official title:

Lymphovascular Abnormalities Under Tattoos : Preliminary Reports of One Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05515146
• Other study ID #: HE2BHERSICGTT
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2022
• Source: Haute Ecole Bruxelles-Brabant
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Tattoo

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Belgium	Pierre Bourgeois	Paliseul

Sponsors (1)

Lead Sponsor	Collaborator
Haute Ecole Bruxelles-Brabant

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	normal or abnormal lympho-vascular drainage	The following pictures were considered as normal; - lymphatic vessels are well seen and drainage is fast spontaneously	imagings were performed directly after the injection (duration 3 minutes)
Primary	normal or abnormal lympho-vascular drainage	The following pictures were considered as normal; - lymphatic vessels are well seen after stretching and massages of the injected site	imagings were performed directly after the stretching and massages (duration 3 minutes)
Primary	normal or abnormal lympho-vascular drainage	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	imagings were performed after a period of normal activities (duration 30 minutes)