Clinical trial NCT05368519: Brijjit® for Wound Closure in Gender Affirming Mastectomies
Official title: A Single-Center Study of Brijjit® - A Force Modulating Tissue Bridge For Skin Closure in Gender-Affirming Mastectomies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mastectomy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility 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)

Primary outcomes:
measure: Subjective scar evaluation by patient outcomes using POSAS
timeFrame: screening/baseline visit
measure: Subjective scar evaluation by patient outcomes using POSAS
timeFrame: week 2 visit
measure: Subjective scar evaluation by patient outcomes using POSAS
timeFrame: week 4 visit
measure: Subjective scar evaluation by patient outcomes using POSAS
timeFrame: week 6 visit
measure: Subjective scar evaluation by patient outcomes using POSAS
timeFrame: week 8 visit
measure: Subjective scar evaluation by patient outcomes using POSAS
timeFrame: 3-month post-surgery visit
measure: Subjective scar evaluation by patient outcomes using POSAS
timeFrame: 6-months post-surgery visit
measure: Subjective scar evaluation by patient outcomes using POSAS
timeFrame: 12-months post-surgery visit
measure: Subjective scar evaluation by surgeon outcomes using POSAS
timeFrame: screening/baseline visit
measure: Subjective scar evaluation by surgeon outcomes using POSAS
timeFrame: week 2 visit
measure: Subjective scar evaluation by surgeon outcomes using POSAS
timeFrame: week 4 visit
measure: Subjective scar evaluation by surgeon outcomes using POSAS
timeFrame: week 6 visit
measure: Subjective scar evaluation by surgeon outcomes using POSAS
timeFrame: week 8 visit
measure: Subjective scar evaluation by surgeon outcomes using POSAS
timeFrame: 3-month post-surgery visit
measure: Subjective scar evaluation by surgeon outcomes using POSAS
timeFrame: 6-months post-surgery visit
measure: Subjective scar evaluation by surgeon outcomes using POSAS
timeFrame: 12-months post-surgery visit
measure: Photographic assessment for objective scar evaluation
timeFrame: screening/baseline visir
measure: Photographic assessment for objective scar evaluation
timeFrame: week 2 visit
measure: Photographic assessment for objective scar evaluation
timeFrame: week 4 visit
measure: Photographic assessment for objective scar evaluation
timeFrame: week 6 visit
measure: Photographic assessment for objective scar evaluation
timeFrame: week 8 visit
measure: Photographic assessment for objective scar evaluation
timeFrame: 3-month post-surgery visit
measure: Photographic assessment for objective scar evaluation
timeFrame: 6-months post-surgery visit
measure: Photographic assessment for objective scar evaluation
timeFrame: 12-months post-surgery visit
measure: Colorimetry of Scar
timeFrame: screening/baseline visit
measure: Colorimetry of Scar
timeFrame: week 2 visit
measure: Colorimetry of Scar
timeFrame: week 4 visit
measure: Colorimetry of Scar
timeFrame: week 6 visit
measure: Colorimetry of Scar
timeFrame: week 8 visit
measure: Colorimetry of Scar
timeFrame: 3-month post-surgery visit
measure: Colorimetry of Scar
timeFrame: 6-months post-surgery visit
measure: Colorimetry of Scar
timeFrame: 12-months post-surgery visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Rachel Bluebond-Langner
role: PRINCIPAL_INVESTIGATOR
References: