Skip to main content
OpenTrials
Completed

NCT Number: NCT02580760

Transgender, Silicone and Blood Smear

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Injection; Complications, Sepsis Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Extravasation of Diagnostic and Therapeutic Materials Infections Inflammation Injection Site Disorder Injection Site Extravasation Injection Site Reaction Intentional Poisoning by Silicone Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat

Paris, 75018, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Size of silicone vacuoles in monocytes

    Time frame: 1 day ,the day of their consultation

  3. Inflammatory and not inflammatory dermatological complications

    Time frame: 1 day ,the day of their consultation

    assessment of dermatological complications during the clinical examination

  4. Number of patients with a positive HIV status

    Time frame: 1 day ,the day of their consultation

    Number of patients with a positive HIV status

  5. Level of immunosuppression estimated with viral charge

    Time frame: 1 day ,the day of their consultation

    HIV viral load, the day of the admission or the last value known in the 6 month prior to the consultation

  6. Level of immunosuppression estimated with cluster of differentiation 4 cell (CD4) rate

    Time frame: 1 day ,the day of their consultation

    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.

  7. Inflammatory syndrome estimated with C-reactive protein (CRP)

    Time frame: 1 day ,the day of their consultation

  8. Inflammatory syndrome estimated with ferritin

    Time frame: 1 day ,the day of their consultation

  9. Amount of injected silicone, in liters

    Time frame: 1 day ,the day of their consultation

  10. Time since the first silicone injection for cosmetic purposes, in years

    Time frame: 1 day ,the day of their consultation

  11. Comorbidities: Number of patients with history of Tuberculosis

    Time frame: 1 day ,the day of their consultation

    Number of patients with history of Tuberculosis

  12. Comorbidities: Number of patients with history of Hepatitis B

    Time frame: 1 day ,the day of their consultation

    Number of patients with history of Hepatitis B

  13. Comorbidities: Number of patients with history of Hepatitis C

    Time frame: 1 day ,the day of their consultation

    Number of patients with history of Hepatitis C

  14. Comorbidities: Number of patients with history of Syphilis

    Time frame: 1 day ,the day of their consultation

    Number of patients with history of Syphilis

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Circulating Silicone After Cosmetic Silicone Injection in Transgender Patients

Acronym: TSBS

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Oct 20, 2015
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.