Transgender, Silicone and Blood Smear

Study Overview
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Brief Summary
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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
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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).

Official Title
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Circulating Silicone After Cosmetic Silicone Injection in Transgender Patients

Conditions
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Injection; Complications, Sepsis, Injection Site Disorder, Injection Site Extravasation, Intentional Poisoning by Silicone

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cosmetic silicone injection<br>People responding to inclusion criteria with a history of cosmetic silicone injection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 day ,the day of their consultation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of monocytes with vacuoles of silicone in a standardized area of 25 monocytes per blood smear slide |  | 1 day ,the day of their consultation | 
| Size of silicone vacuoles in monocytes |  | 1 day ,the day of their consultation | 
| Inflammatory and not inflammatory dermatological complications | assessment of dermatological complications during the clinical examination | 1 day ,the day of their consultation | 
| Number of patients with a positive HIV status | Number of patients with a positive HIV status | 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 | 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. | 1 day ,the day of their consultation | 
| Inflammatory syndrome estimated with C-reactive protein (CRP) |  | 1 day ,the day of their consultation | 
| Inflammatory syndrome estimated with ferritin |  | 1 day ,the day of their consultation | 
| Amount of injected silicone, in liters |  | 1 day ,the day of their consultation | 
| Time since the first silicone injection for cosmetic purposes, in years |  | 1 day ,the day of their consultation | 
| Comorbidities: Number of patients with history of Tuberculosis | Number of patients with history of Tuberculosis | 1 day ,the day of their consultation | 
| Comorbidities: Number of patients with history of Hepatitis B | Number of patients with history of Hepatitis B | 1 day ,the day of their consultation | 
| Comorbidities: Number of patients with history of Hepatitis C | Number of patients with history of Hepatitis C | 1 day ,the day of their consultation | 
| Comorbidities: Number of patients with history of Syphilis | Number of patients with history of Syphilis | 1 day ,the day of their consultation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silicone, Transgender, Dermatology, Blood contamination, Adverse event after injection