Lymphovascular Abnormalities Under Tattoos

Lymphovascular Abnormalities Under Tattoos : Preliminary Reports of One Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Tattoo
• Intervention / Treatment: Diagnostic test: near infra red fluorescence lymphatic imaging

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 Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• Belgium
  • Paliseul, Belgium, 6850
    • Pierre Bourgeois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

nineteen subjects (nine women and ten men; mean age = 28.6, range 23-39 years) with tattoos at the level, either of the lower limb (n = 11), or of the upper limb (n = 9) Except in 4 cases, tattoos were older than 2 years (mean = 52.5 months).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Haute Ecole Bruxelles-Brabant

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: lymphatic vessels; indocyanin green; near infra red fluorescence lymphatic imaging; tattoo
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: HE2BHERSICGTT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No