Brijjit® for Wound Closure in Gender Affirming Mastectomies

NYU Langone Health

Status: Withdrawn

Conditions: Mastectomy

Treatments: Device: Brijjit®

Study type: Interventional

Funder types: Other

Identifiers

NCT05368519

22-00304

Details and patient eligibility

About

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

Full 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).

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Right chest with Brijjit® FMTB

Experimental group

Description:

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.

Treatment:

Device: Brijjit®

Left chest with Brijjit® FMTB

Experimental group

Description:

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.

Treatment:

Device: Brijjit®