Progressive Tension Sutures in Gender Affirming Mastectomy

Study Overview
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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.

Official Title
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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

Conditions
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Hematoma, Seroma

Intervention / Treatment
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* Procedure: Progressive Tension Sutures


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right-Sided Progressive Tension Sutures<br> | Procedure: Progressive Tension Sutures<br>* 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)<br>|
| Active Comparator: Left-Sided Progressive Tension Sutures<br> | Procedure: Progressive Tension Sutures<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mastectomy