Lymphovascular Abnormalities Under Tattoos

NCT05515146 | Completed

• 1 other identifier: HE2BHERSICGTT
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Tattoo

Keywords

lymphatic vessels; indocyanin green; near infra red fluorescence lymphatic imaging; tattoo

Outcome Measures

Primary Outcomes (3)

• 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)

Interventions

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haute Ecole Bruxelles-Brabant: lead

Study Sites (1)

Pierre Bourgeois

Paliseul, 6850, Belgium

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr P Bourgeois

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 25, 2022
• Study Start: December 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)