Progressive Tension Sutures in Gender Affirming Mastectomy

Not Applicable

Terminated

• Conditions: Seroma; Hematoma
• Interventions: Procedure: Progressive Tension Sutures

• Registration Number: NCT04818580
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-25
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Primary Completion: 2022-06-21
• Study Completion: 2022-06-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Right-Sided Progressive Tension Sutures	Progressive Tension Sutures	-
Left-Sided Progressive Tension Sutures	Progressive Tension Sutures	-

Primary Outcome Measures

Name	Time	Method
Total volume of Drain Fluid	Visit 4, Day 30	Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States