Lymphovascular Abnormalities Under Tattoos

Completed

• Conditions: Tattoo

• Registration Number: NCT05515146
• Lead Sponsor: Haute Ecole Bruxelles-Brabant

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.

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-08
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-24
• Last Update Submitted: 2022-08-24
• Study First Posted: 2022-08-25
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
normal or abnormal lympho-vascular drainage	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

Trial Locations

Locations (1)

Pierre Bourgeois; 🇧🇪 Paliseul, Belgium