Progressive Tension Sutures in Gender Affirming Mastectomy

NYU Langone Health

Status: Terminated

Conditions: Seroma; Hematoma

Treatments: Procedure: Progressive Tension Sutures

Study type: Interventional

Funder types: Other

Identifiers

NCT04818580

20-01803

Details and patient eligibility

About

50 patients seeking gender affirming mastectomy will be treated with different closure techniques in each side of their chest - one side will receive progressive tension sutures between pectoral fascia and the mastectomy flap, and the other side will not. Both sides will have drains in the mastectomy site. Rates of hematoma, seroma, and other complications will be compared between each chest side via standard statistical techniques for hypothesis testing.

Enrollment: 3 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Being consulted for gender affirming mastectomy with the senior author (AH).
2. >18 years of age at the time of enrollment.
3. Transgender or gender nonbinary gender identity.
4. All co-morbidities and all indications.

Exclusion criteria

1. Age less than 18 years.
2. BMI < 23.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 2 patient groups

Right-Sided Progressive Tension Sutures

Experimental group

Treatment:

Procedure: Progressive Tension Sutures

Left-Sided Progressive Tension Sutures

Active Comparator group

Treatment:

Procedure: Progressive Tension Sutures