Hematoma, Seroma
Conditions
Keywords
Mastectomy
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.
Interventions
PROCEDUREProgressive 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)
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
A random number generator will be used. Subjects will be blinded as to which side of the chest has the sutures.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total volume of Drain Fluid | Visit 2, Day 7 | Participants will record drain outputs each time they empty drains in the Postoperative Drain Output Record (mL) |
Countries
United States
Outcome results
None listed