Progressive Tension Sutures in Gender Affirming Mastectomy

Sponsor

NYU Langone Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT04818580

Collaborator

(none)

Enrollment

Location

Arms

33.2

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematoma Seroma	Procedure: Progressive Tension Sutures	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

A random number generator will be used. Subjects will be blinded as to which side of the chest has the sutures.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 25, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Right-Sided Progressive Tension Sutures	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)
Active Comparator: Left-Sided Progressive Tension Sutures	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)

Arm

Intervention/Treatment

Experimental: Right-Sided Progressive Tension Sutures

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)

Active Comparator: Left-Sided Progressive Tension Sutures

Procedure: Progressive Tension Sutures

Outcome Measures

Primary Outcome Measures

Total volume of Drain Fluid [Visit 2, Day 7]
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Total volume of Drain Fluid [Visit 3, Day 14]
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Age less than 18 years.
BMI < 23.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Alexes Hazen, MD FACS, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT04818580

Other Study ID Numbers:

20-01803

First Posted:

Mar 26, 2021

Last Update Posted:

Mar 4, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by NYU Langone Health

Mastectomy

Additional relevant MeSH terms:

Hematoma

Seroma

Study Results

No Results Posted as of Mar 4, 2022