TattooNCT05515146
Lymphovascular Abnormalities Under Tattoos
An observational study of Tattoo, run by Haute Ecole Bruxelles-Brabant at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tattoo
- What is being tested?
- near infra red fluorescence lymphatic imaging
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2021to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Adult
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).
Who may be able to join
- presence of one tattoo at the level of one limb
- written informed consent
Who cannot join
- 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);
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tattoo
- Being tested
- near infra red fluorescence lymphatic imaging
- Keywords
- lymphatic vessels, indocyanin green, near infra red fluorescence lymphatic imaging, tattoo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near infra red fluorescence lymphatic imagingDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
normal or abnormal lympho-vascular drainage
The following pictures were considered as normal
- lymphatic vessels are well seen and drainage is fast spontaneously
Measured: 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
Measured: 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
Measured: imagings were performed after a period of normal activities (duration 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Dec 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TattooStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haute Ecole Bruxelles-Brabant
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bourgeois Pierre, Haute Ecole Bruxelles-Brabant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515146
- Sponsor's protocol ID
- HE2BHERSICGTT
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphovascular Abnormalities Under Tattoos : Preliminary Reports of One Observational Study
- ClinicalTrials.gov ID
- NCT05515146
- Acronym / sponsor ID
- HE2BHERSICGTT
- Conditions
- Tattoo
- Keywords
- lymphatic vessels, indocyanin green, near infra red fluorescence lymphatic imaging, tattoo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Haute Ecole Bruxelles-BrabantUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- 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).
Key inclusion criteria (2 listed)
- presence of one tattoo at the level of one limb
- written informed consent
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| near infra red fluorescence lymphatic imagingICG (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 | Diagnostic test | – |
Primary outcome
normal or abnormal lympho-vascular drainage
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tattoo, run by Haute Ecole Bruxelles-Brabant at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
normal or abnormal lympho-vascular drainage (time frame: imagings were performed directly after the injection (duration 3 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.