NCT04818580

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2022

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

March 25, 2021

Last Update Submit

January 26, 2023

Conditions

HematomaSeroma

Keywords

Mastectomy

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Right-Sided Progressive Tension Sutures

EXPERIMENTAL
Procedure: Progressive Tension Sutures

Left-Sided Progressive Tension Sutures

ACTIVE COMPARATOR
Procedure: Progressive Tension Sutures

Interventions

Progressive Tension SuturesPROCEDURE

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)

Left-Sided Progressive Tension SuturesRight-Sided Progressive Tension Sutures

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsTransgender men
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Age less than 18 years.
  • BMI \< 23.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

HematomaSeroma

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsInflammation

Study Officials

  • Alexes Hazen, MD FACS

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A random number generator will be used. Subjects will be blinded as to which side of the chest has the sutures.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 26, 2021

Study Start

March 25, 2021

Primary Completion

June 21, 2022

Study Completion

June 21, 2022

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Thomas.Calahan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)