Progressive Tension Sutures in Gender Affirming Mastectomy

NCT ID: NCT04818580

Last Updated: 2023-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2022-06-21

Brief Summary

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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

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Conditions

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Hematoma Seroma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Right-Sided Progressive Tension Sutures

Group Type EXPERIMENTAL

Progressive Tension Sutures

Intervention Type PROCEDURE

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 Sutures

Group Type ACTIVE_COMPARATOR

Progressive Tension Sutures

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexes Hazen, MD FACS

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20-01803

Identifier Type: -

Identifier Source: org_study_id

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