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Departure of key personnel, difficulties with recruiting.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right-Sided Progressive Tension Sutures | Experimental |
| |
| Left-Sided Progressive Tension Sutures | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive Tension Sutures | 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Transgender men
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| Name | Affiliation | Role |
|---|---|---|
| Alexes Hazen, MD FACS | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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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| ID | Term |
|---|---|
| D006406 | Hematoma |
| D049291 | Seroma |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007249 | Inflammation |
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A random number generator will be used. Subjects will be blinded as to which side of the chest has the sutures.
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