Lymphovascular Abnormalities Under Tattoos

Sponsor

Haute Ecole Bruxelles-Brabant (Other)

Overall Status

Completed

CT.gov ID

NCT05515146

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tattoo	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 Design

Study Type:

Observational

Actual Enrollment :

19 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Lymphovascular Abnormalities Under Tattoos : Preliminary Reports of One Observational Study

Actual Study Start Date :

Dec 1, 2021

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Jan 31, 2022

Outcome Measures

Primary Outcome Measures

normal or abnormal lympho-vascular drainage [imagings were performed directly after the injection (duration 3 minutes)]
The following pictures were considered as normal - lymphatic vessels are well seen and drainage is fast spontaneously
normal or abnormal lympho-vascular drainage [imagings were performed directly after the stretching and massages (duration 3 minutes)]
The following pictures were considered as normal - lymphatic vessels are well seen after stretching and massages of the injected site
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pierre Bourgeois	Paliseul		Belgium	6850

Sponsors and Collaborators

Haute Ecole Bruxelles-Brabant

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bourgeois Pierre, Prof Dr P Bourgeois, Haute Ecole Bruxelles-Brabant

ClinicalTrials.gov Identifier:

NCT05515146

Other Study ID Numbers:

HE2BHERSICGTT

First Posted:

Aug 25, 2022

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bourgeois Pierre, Prof Dr P Bourgeois, Haute Ecole Bruxelles-Brabant

lymphatic vessels

indocyanin green

near infra red fluorescence lymphatic imaging

tattoo

Additional relevant MeSH terms:

Congenital Abnormalities

Study Results

No Results Posted as of Aug 25, 2022