Progressive Tension Sutures in Gender Affirming Mastectomy

Seroma Clinical Trial

Official title:

A Prospective Cohort Study Comparing the Effect of Progressive Tension Sutures and Drains to Drains Alone on Rates of Hematoma and Seroma in Gender Affirming Mastectomy for Transgender Men

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04818580
• Other study ID #: 20-01803
• Status: Terminated
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: June 21, 2022

Study information

• Verified date: January 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 21, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematoma
• Seroma

Intervention

Procedure:
• Progressive Tension Sutures
In each patient, one side of the chest will receive progressive tension sutures inside the mastectomy pocket, from pectoral fascia to underside of mastectomy flap. 2-0 Vicryl about 15-20 sutures per chest. Both sides will receive bilateral drains (standard of care)

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total volume of Drain Fluid	Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)	Visit 2, Day 7
Primary	Total volume of Drain Fluid	Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)	Visit 3, Day 14
Primary	Total volume of Drain Fluid	Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)	Visit 4, Day 30