Clinical trial NCT02580760: Transgender, Silicone and Blood Smear
Official title: Circulating Silicone After Cosmetic Silicone Injection in Transgender Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Injection; Complications, Sepsis
Injection Site Disorder
Injection Site Extravasation
Intentional Poisoning by Silicone
Keywords: Silicone
Transgender
Dermatology
Blood contamination
Adverse event after injection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every transgender men transitioning into women patients with cosmetic silicone injection and consulting in Bichat hospital.

Brief 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 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).

Eligibility criteria: Inclusion Criteria:

* Adults
* Not in opposition to data collection
* Transgender men transitioning into women patients with cosmetic silicone injection
* Consultation in Bichat hospital

Exclusion Criteria:

* Unable to communicate
* Guardianship, curatorship

Primary outcomes:
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.
timeFrame: 1 day ,the day of their consultation
Secondary outcomes:
measure: Number of monocytes with vacuoles of silicone in a standardized area of 25 monocytes per blood smear slide
timeFrame: 1 day ,the day of their consultation
measure: Size of silicone vacuoles in monocytes
timeFrame: 1 day ,the day of their consultation
measure: Inflammatory and not inflammatory dermatological complications
timeFrame: 1 day ,the day of their consultation
measure: Number of patients with a positive HIV status
timeFrame: 1 day ,the day of their consultation
measure: Level of immunosuppression estimated with viral charge
timeFrame: 1 day ,the day of their consultation
measure: Level of immunosuppression estimated with cluster of differentiation 4 cell (CD4) rate
timeFrame: 1 day ,the day of their consultation
measure: Inflammatory syndrome estimated with C-reactive protein (CRP)
timeFrame: 1 day ,the day of their consultation
measure: Inflammatory syndrome estimated with ferritin
timeFrame: 1 day ,the day of their consultation
measure: Amount of injected silicone, in liters
timeFrame: 1 day ,the day of their consultation
measure: Time since the first silicone injection for cosmetic purposes, in years
timeFrame: 1 day ,the day of their consultation
measure: Comorbidities: Number of patients with history of Tuberculosis
timeFrame: 1 day ,the day of their consultation
measure: Comorbidities: Number of patients with history of Hepatitis B
timeFrame: 1 day ,the day of their consultation
measure: Comorbidities: Number of patients with history of Hepatitis C
timeFrame: 1 day ,the day of their consultation
measure: Comorbidities: Number of patients with history of Syphilis
timeFrame: 1 day ,the day of their consultation
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat
Study officials:
affiliation: Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat
name: Fabrice Bouscarat, MD
role: STUDY_DIRECTOR
References: