Transgender, Silicone and Blood Smear (TSBS)

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).

Study Overview

• Status: Completed
• Conditions: Injection; Complications, Sepsis; Injection Site Disorder; Injection Site Extravasation; Intentional Poisoning by Silicone

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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Every transgender men transitioning into women patients with cosmetic silicone injection and consulting in Bichat hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cosmetic silicone injection; People responding to inclusion criteria with a history of cosmetic silicone injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Fabrice Bouscarat, MD, Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: October 18, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Estimate): January 25, 2016
• Last Update Submitted That Met QC Criteria: January 22, 2016
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Silicone; Dermatology; Transgender; Blood contamination; Adverse event after injection
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Extravasation of Diagnostic and Therapeutic Materials; Poisoning; Injection Site Reaction
• Other Study ID Numbers: 15FBT-TSBS