Status:
WITHDRAWN
Brijjit® for Wound Closure in Gender Affirming Mastectomies
Lead Sponsor:
NYU Langone Health
Conditions:
Mastectomy
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This study will evaluate the use of Brijjit® for wound closure in individuals undergoing bilateral double incision gender affirming mastectomies with a single surgeon (Rachel Bluebond-Langner, MD). Th...
Detailed Description
The hypothesis of this study is that the use of Brijjit® FMTB will result in improved scar outcomes as measured by both patient and treating physician as compared to traditional suture based wound clo...
Eligibility Criteria
Inclusion
- Patient self-identifies as Transgender or Gender Expansive
- Patient will undergo primary bilateral double incision mastectomy at NYULH
- All clinical criteria to be eligible for primary mastectomy must be met
- Ability to care for donor site and adhere to wound therapy (either solo or with care-giver assistance)
- Willingness to return for scheduled follow-up visits through 1 year post-operatively
- 18 years of age or older
- English Speaking
Exclusion
- Individuals with previously diagnosed allergies or a history of adverse effects related to adhesives / adhesive tapes
- Individuals with a history of the following prescription medication use in the last year: Accutane, Systemic glucocorticoids and/or Local glucocorticoids or immunosuppressants (i.e. topical tacrolimus, topical clindamycin etc.) at the intervention site
- Individuals with a history of significant scarring or adverse scarring (hypertrophic scars or keloid scars)
- Individuals with pre-existing scars at the GAM wound closure site
- Individuals with a disorder known to negatively affect wound healing (i.e. autoimmune disease, connective tissue disease)
- Individuals with malnutrition
- Individuals with a BMI \>30 kg/m2
- Individuals with a history of radiation therapy
- Active smokers or smokeless nicotine use
- History of Previous Mastectomy
- Patient is actively immunosuppressed i.e. AIDS (HIV+ acceptable), or Systemic immunosuppressants
- Patients unable to attend post-operative follow-ups in person
- Patients with a considerable history of medical non-compliance
- Patient will receive GAM not including double incisions (i.e. periareolar)
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05368519
Start Date
June 1 2022
End Date
April 19 2024
Last Update
August 9 2022
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016