The goal of this randomized, prospective, interventional clinical trial is to evaluate the use of Brijjit® in reducing the incidence of hypertrophic scarring in individuals undergoing gender-affirming bilateral double incision mastectomies at a single-institution, single-surgeon site (Esther A. Kim, MD). Patients will serve as a self-control (one side of the chest receives intervention, the other serves as a control). Primary endpoints include scar appearance and quality. Secondary endpoints include patient perception of the scar using the Patient and Observer Scar Assessment Scale (POSAS).
Participants will be taught how to apply Brijjit® at home if any units fall off before 6 weeks postop.
Age ≥ 19
Undergoing double incision gender affirming mastectomy
Ability to adhere to Brijjit therapy after surgery
Willing to return for follow-up visits and undergo study evaluations
History of keloid formation
Radiation therapy history
Prior surgeries of the chest or breast
History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids
Single group
Brijjit® BP100-6 and BP-75
DeviceBrijjit® BP-100 and BP-75 are a non-invasive, flexible devices that acts as a force modulating tissue bridge (FMTB) to aid in wound healing. BP-100 and BP-75 simply refer to different sizes of the Brijjit device.
Control: Standard of care and normal wound dressing
Other interventionThe control chest side will receive only standard of care and normal wound dressing.
Presence of Hypertrophic Scarring
Presence or Absence of HTS: HTS defined as a raised, firm fibrotic lesion that develops within the boundaries of surgical incision with a height cutoff of \>/= 1mm. Binary yes or no outcome.
Presence of Hypertrophic Scarring
Presence or Absence of HTS: HTS defined as a raised, firm fibrotic lesion that develops within the boundaries of surgical incision with a height cutoff of \>/= 1mm. Binary yes or no outcome.
Presence of Hypertrophic Scarring
Presence or Absence of HTS: HTS defined as a raised, firm fibrotic lesion that develops within the boundaries of surgical incision with a height cutoff of \>/= 1mm. Binary yes or no outcome.
Presence of Hypertrophic Scarring
Presence or Absence of HTS: HTS defined as a raised, firm fibrotic lesion that develops within the boundaries of surgical incision with a height cutoff of \>/= 1mm. Binary yes or no outcome.
Patient Perception of Scar
Use the Patient and Observer Scar Assessment Scale (POSAS): A validated, widely used questionnaire consisting of both patient and observer scales regarding scar appearance, physical symptoms (e.g. pain, pruritus), and overall patient satisfaction. This scale allows for scores ranging from 1-10, with higher scores meaning a worse outcome. Patients will be given this survey in clinic, but will be given the option of completing it electronically at home.
Patient Perception of Scar
Use the Patient and Observer Scar Assessment Scale (POSAS): A validated, widely used questionnaire consisting of both patient and observer scales regarding scar appearance, physical symptoms (e.g. pain, pruritus), and overall patient satisfaction. This scale allows for scores ranging from 1-10, with higher scores meaning a worse outcome. Patients will be given this survey in clinic, but will be given the option of completing it electronically at home.
Patient Perception of Scar
Use the Patient and Observer Scar Assessment Scale (POSAS): A validated, widely used questionnaire consisting of both patient and observer scales regarding scar appearance, physical symptoms (e.g. pain, pruritus), and overall patient satisfaction. This scale allows for scores ranging from 1-10, with higher scores meaning a worse outcome. Patients will be given this survey in clinic, but will be given the option of completing it electronically at home.
Patient Perception of Scar
Use the Patient and Observer Scar Assessment Scale (POSAS): A validated, widely used questionnaire consisting of both patient and observer scales regarding scar appearance, physical symptoms (e.g. pain, pruritus), and overall patient satisfaction. This scale allows for scores ranging from 1-10, with higher scores meaning a worse outcome. Patients will be given this survey in clinic, but will be given the option of completing it electronically at home.
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