Injection; Complications, SepsisTSBSNCT02580760
Transgender, Silicone and Blood Smear
An observational study of Injection; Complications, Sepsis and Injection Site Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection. The principal objective is to estimate the prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smears among Male to Female Transgender population… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Injection; Complications, Sepsis, Injection Site Disorder, Injection Site Extravasation
- Type of treatment
- Injection or infusion
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Jan 2016
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Every transgender men transitioning into women patients with cosmetic silicone injection and consulting in Bichat hospital.
Who may be able to join
- Adults
- Not in opposition to data collection
- Transgender men transitioning into women patients with cosmetic silicone injection
- Consultation in Bichat hospital
Who cannot join
- Unable to communicate
- Guardianship, curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat
Paris, 75018
About this study
Official title: Circulating Silicone After Cosmetic Silicone Injection in Transgender Patients
This cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection.
The principal objective is to estimate the prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smears among Male to Female Transgender population with a history of cosmetic silicon injections.
The secondary objectives are to describe the transgender population, to describe the quantity of silicone in vacuoles of circulating monocytes, and the association between dermatological complications (inflammatory and not inflammatory) and several clinical and biological characteristics (HIV status, level of immunosuppression, inflammatory syndrome, quantity of silicone which was injected , silicone quantity in blood smears).
Read the detailed description
Injectable liquid silicone is a permanent filling product which is no more used in France because of a high risk of complications. Cosmetic silicone injection is a common feminization approach for transgender populations.
This cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection.
The principal objective is to estimate the prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smears among Male to Female Transgender population with a history of cosmetic silicon injections.
The secondary objectives are to describe the transgender population, to describe the quantity of silicone in vacuoles of circulating monocytes, and the association between dermatological complications (inflammatory and not inflammatory) and several clinical and biological characteristics (HIV status, level of immunosuppression, inflammatory syndrome, quantity of silicone which was injected , silicone quantity in blood smears).
- Conditions
- Injection; Complications, Sepsis, Injection Site Disorder, Injection Site Extravasation, Intentional Poisoning by Silicone
- Keywords
- Silicone, Transgender, Dermatology, Blood contamination, Adverse event after injection
- Medical subject headings
- Sepsis, Injection Site Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cosmetic silicone injection | People responding to inclusion criteria with a history of cosmetic silicone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smear among Male to Female Transgender population, the day of their consultation.
The prevalence of Transgender with circulating monocytes containing silicone vacuoles will be calculated as the number of subjects with monocytes containing silicone vacuoles in blood smears on the number of subjects with a history of silicone cosmetic injection
Measured: 1 day ,the day of their consultation
Secondary outcomes (14)
Number of monocytes with vacuoles of silicone in a standardized area of 25 monocytes per blood smear slide
Measured: 1 day ,the day of their consultation
Size of silicone vacuoles in monocytes
Measured: 1 day ,the day of their consultation
Inflammatory and not inflammatory dermatological complications
assessment of dermatological complications during the clinical examination
Measured: 1 day ,the day of their consultation
Number of patients with a positive HIV status
Number of patients with a positive HIV status
Measured: 1 day ,the day of their consultation
Level of immunosuppression estimated with viral charge
HIV viral load, the day of the admission or the last value known in the 6 month prior to the consultation
Measured: 1 day ,the day of their consultation
Level of immunosuppression estimated with cluster of differentiation 4 cell (CD4) rate
CD4 cell count the day of the consultation or the last value known in the 6 month prior to the consultation.
CD4 cell stands for Cluster of differentiation antigen 4 cell.
Measured: 1 day ,the day of their consultation
Inflammatory syndrome estimated with C-reactive protein (CRP)
Measured: 1 day ,the day of their consultation
Inflammatory syndrome estimated with ferritin
Measured: 1 day ,the day of their consultation
Amount of injected silicone, in liters
Measured: 1 day ,the day of their consultation
Time since the first silicone injection for cosmetic purposes, in years
Measured: 1 day ,the day of their consultation
Comorbidities: Number of patients with history of Tuberculosis
Number of patients with history of Tuberculosis
Measured: 1 day ,the day of their consultation
Comorbidities: Number of patients with history of Hepatitis B
Number of patients with history of Hepatitis B
Measured: 1 day ,the day of their consultation
Comorbidities: Number of patients with history of Hepatitis C
Number of patients with history of Hepatitis C
Measured: 1 day ,the day of their consultation
Comorbidities: Number of patients with history of Syphilis
Number of patients with history of Syphilis
Measured: 1 day ,the day of their consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection; Complications, SepsisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice Bouscarat, MD, Study director, Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580760
- Sponsor's protocol ID
- 15FBT-TSBS
- Acronym
- TSBS
- Status last verified
- Sep 2015
- First submitted
- 30 Sep 2015
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Silicone After Cosmetic Silicone Injection in Transgender Patients
- ClinicalTrials.gov ID
- NCT02580760
- Acronym / sponsor ID
- TSBS / 15FBT-TSBS
- Conditions
- Injection; Complications, Sepsis, Injection Site Disorder, Injection Site Extravasation, Intentional Poisoning by Silicone
- Keywords
- Silicone, Transgender, Dermatology, Blood contamination, Adverse event after injection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Oct 2015 (estimated)
- 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.
This cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection.
The principal objective is to estimate the prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smears among Male to Female Transgender population with a history of cosmetic silicon injections.
The secondary objectives are to describe the transgender population, to describe the quantity of silicone in vacuoles of circulating monocytes, and the association between dermatological complications (inflammatory and not inflammatory) and several clinical and biological characteristics (HIV status, level of immunosuppression, inflammatory syndrome, quantity of silicone which was injected , silicone quantity in blood smears).
Detailed description
Injectable liquid silicone is a permanent filling product which is no more used in France because of a high risk of complications. Cosmetic silicone injection is a common feminization approach for transgender populations.
This cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection.
The principal objective is to estimate the prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smears among Male to Female Transgender population with a history of cosmetic silicon injections.
The secondary objectives are to describe the transgender population, to describe the quantity of silicone in vacuoles of circulating monocytes, and the association between dermatological complications (inflammatory and not inflammatory) and several clinical and biological characteristics (HIV status, level of immunosuppression, inflammatory syndrome, quantity of silicone which was injected , silicone quantity in blood smears).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cosmetic silicone injection | – | –People responding to inclusion criteria with a history of cosmetic silicone injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every transgender men transitioning into women patients with cosmetic silicone injection and consulting in Bichat hospital.
Key inclusion criteria (4 listed)
- Adults
- Not in opposition to data collection
- Transgender men transitioning into women patients with cosmetic silicone injection
- Consultation in Bichat hospital
Key exclusion criteria (2 listed)
- Unable to communicate
- Guardianship, curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smear among Male to Female Transgender population, the day of their consultation.
Time frame: 1 day ,the day of their consultation
The prevalence of Transgender with circulating monocytes containing silicone vacuoles will be calculated as the number of subjects with monocytes containing silicone vacuoles in blood smears on the number of subjects with a history of silicone cosmetic injection
14 secondary outcomes
Number of monocytes with vacuoles of silicone in a standardized area of 25 monocytes per blood smear slide
Time frame: 1 day ,the day of their consultation
Size of silicone vacuoles in monocytes
Time frame: 1 day ,the day of their consultation
Inflammatory and not inflammatory dermatological complications
Time frame: 1 day ,the day of their consultation
Number of patients with a positive HIV status
Time frame: 1 day ,the day of their consultation
Level of immunosuppression estimated with viral charge
Time frame: 1 day ,the day of their consultation
Level of immunosuppression estimated with cluster of differentiation 4 cell (CD4) rate
Time frame: 1 day ,the day of their consultation
Inflammatory syndrome estimated with C-reactive protein (CRP)
Time frame: 1 day ,the day of their consultation
Inflammatory syndrome estimated with ferritin
Time frame: 1 day ,the day of their consultation
Amount of injected silicone, in liters
Time frame: 1 day ,the day of their consultation
Time since the first silicone injection for cosmetic purposes, in years
Time frame: 1 day ,the day of their consultation
Comorbidities: Number of patients with history of Tuberculosis
Time frame: 1 day ,the day of their consultation
Comorbidities: Number of patients with history of Hepatitis B
Time frame: 1 day ,the day of their consultation
Comorbidities: Number of patients with history of Hepatitis C
Time frame: 1 day ,the day of their consultation
Comorbidities: Number of patients with history of Syphilis
Time frame: 1 day ,the day of their consultation
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 Jan 2016.
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.
Fabrice Bouscarat, MD study director
Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat
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 Injection; Complications, Sepsis and Injection Site Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 2 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 Jan 2016. 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 France. 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?
The prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smear among Male to Female Transgender population, the day of their consultation. (time frame: 1 day ,the day of their consultation). 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 Jan 2016.