Injection Site Disorder Clinical Trial
— TSBSOfficial 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).
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | January 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No | |
| Secondary | Size of silicone vacuoles in monocytes | 1 day ,the day of their consultation | No | |
| Secondary | Inflammatory and not inflammatory dermatological complications | assessment of dermatological complications during the clinical examination | 1 day ,the day of their consultation | No |
| Secondary | Number of patients with a positive HIV status | Number of patients with a positive HIV status | 1 day ,the day of their consultation | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Inflammatory syndrome estimated with C-reactive protein (CRP) | 1 day ,the day of their consultation | No | |
| Secondary | Inflammatory syndrome estimated with ferritin | 1 day ,the day of their consultation | No | |
| Secondary | Amount of injected silicone, in liters | 1 day ,the day of their consultation | No | |
| Secondary | Time since the first silicone injection for cosmetic purposes, in years | 1 day ,the day of their consultation | No | |
| Secondary | Comorbidities: Number of patients with history of Tuberculosis | Number of patients with history of Tuberculosis | 1 day ,the day of their consultation | No |
| Secondary | Comorbidities: Number of patients with history of Hepatitis B | Number of patients with history of Hepatitis B | 1 day ,the day of their consultation | No |
| Secondary | Comorbidities: Number of patients with history of Hepatitis C | Number of patients with history of Hepatitis C | 1 day ,the day of their consultation | No |
| Secondary | Comorbidities: Number of patients with history of Syphilis | Number of patients with history of Syphilis | 1 day ,the day of their consultation | No |