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NCT05368519 | Withdrawn | Mastectomy

Brijjit® for Wound Closure in Gender Affirming Mastectomies
Sponsor:

NYU Langone Health

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). The study will be a randomized prospective interventional study utilizing internal controls (one side of chest receives intervention, other serves as control). Primary endpoints will include scar appearance/quality and wound complications

Condition or disease

Mastectomy

Intervention/treatment

Brijjit®

Phase

Not Applicable

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 closure methods. As mentioned, at present there is no standard of care for wound closure following double incision GAM, therefore an internal control approach will be taken with patients serving as their own controls. This will be achieved by having one side of the chest receive the of Brijjit® FMTB (intervention) in addition to suture closure of the skin, while the other side will be closed with traditional methods, a combination of sutures and steri-stripsTM (control).}}

Study Type : Interventional
Estimated Enrollment : 0 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Single-Center Study of Brijjit® - A Force Modulating Tissue Bridge For Skin Closure in Gender-Affirming Mastectomies
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : April 19, 2024
Estimated Study Completion Date : April 19, 2024
Arm Intervention/treatment

Experimental: Right chest with Brijjit® FMTB

Patients will be assigned to have their right chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control.

Device: Brijjit®

Experimental: Left chest with Brijjit® FMTB

Patients will be assigned to have their left chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control.

Device: Brijjit®
Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • 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 Criteria
  • 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)
Brijjit® for Wound Closure in Gender Affirming Mastectomies

Location Details

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Brijjit® for Wound Closure in Gender Affirming Mastectomies

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, New York

NYU Langone Health

New York, New York, United States, 10016