Back to resultsProgressive Tension Sutures in Gender Affirming Mastectomy
Primary Purpose
Hematoma, Seroma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progressive Tension Sutures
Sponsored by
About this trial
This is an interventional treatment trial for Hematoma focused on measuring Mastectomy
Eligibility Criteria
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.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Right-Sided Progressive Tension Sutures
Left-Sided Progressive Tension Sutures
Arm Description
Outcomes
Primary Outcome Measures
Total volume of Drain Fluid
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Total volume of Drain Fluid
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Total volume of Drain Fluid
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04818580
Brief Title
Progressive Tension Sutures in Gender Affirming Mastectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Departure of key personnel, difficulties with recruiting.
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
June 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematoma, Seroma
Keywords
Mastectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
A random number generator will be used. Subjects will be blinded as to which side of the chest has the sutures.
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Right-Sided Progressive Tension Sutures
Arm Type
Experimental
Arm Title
Left-Sided Progressive Tension Sutures
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Progressive Tension Sutures
Intervention Description
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)
Primary Outcome Measure Information:
Title
Total volume of Drain Fluid
Description
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Time Frame
Visit 2, Day 7
Title
Total volume of Drain Fluid
Description
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Time Frame
Visit 3, Day 14
Title
Total volume of Drain Fluid
Description
Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)
Time Frame
Visit 4, Day 30
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Transgender men
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexes Hazen, MD FACS
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
Progressive Tension Sutures in Gender Affirming Mastectomy
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