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Transgender, Silicone and Blood Smear (TSBS)

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT02580760
15FBT-TSBS

Details and patient eligibility

About

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).

Full 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).

Enrollment

66 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

66 participants in 1 patient group

Cosmetic silicone injection
Description:
People responding to inclusion criteria with a history of cosmetic silicone injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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