NCT04818580

Progressive Tension Sutures in Gender Affirming Mastectomy

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematoma
• Seroma

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-03-25
• Primary completion: 2022-06-21
• Completion: 2022-06-21
• First posted: 2021-03-26
• Last updated: 2023-01-30

Locations

1 site across 1 country: United States