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Progressive Tension Sutures in Gender Affirming Mastectomy

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ClinicalTrials.gov Identifier: NCT04818580
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 25, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Total volume of Drain Fluid [ Time Frame: Visit 2, Day 7 ]
    Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)

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

  3. Total volume of Drain Fluid [ Time Frame: Visit 4, Day 30 ]
    Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Transgender men
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04818580


Contacts
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Contact: Thomas Calahan 9294555826 Thomas.Calahan@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Thomas Calahan       Thomas.Calahan@nyulangone.org   
Principal Investigator: Alexes Hazen, MD FACS         
Sub-Investigator: Ian Nolan, BM         
Sub-Investigator: David Daar         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Alexes Hazen, MD FACS NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04818580    
Other Study ID Numbers: 20-01803
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Mastectomy
Additional relevant MeSH terms:
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Hematoma
Seroma
Hemorrhage
Pathologic Processes
Inflammation