Brijjit® Device for Preventing Scars After Gender-Affirming Mastectomy
This study is testing a device called Brijjit® (BP100-6 and BP-75) to see if it can help prevent thick, raised scars (hypertrophic scars) after gender-affirming mastectomy. The Brijjit® device is a flexible, non-invasive tool that helps wounds heal. You could be eligible if you are at least 19 years old, having a double incision gender-affirming mastectomy, and can follow the study instructions and attend follow-up visits. The study will compare how well the Brijjit® device works on one side of your chest versus standard wound care on the other side. Researchers will check for hypertrophic scars at 6 weeks, 3 months, and 6 months after surgery. The goal is to see if Brijjit® can reduce scarring.
- Study design
- This is a randomized study involving 78 participants. Each participant will have the Brijjit® device on one side of their chest and standard care on the other side.
- What's involved
- You would need to apply the Brijjit® device after surgery and be willing to return for follow-up visits and study evaluations. You will be taught how to reapply the device at home if needed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after surgery, with scar assessments at 6 weeks, 3 months, and 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Esther A Kim, MD · PRINCIPAL_INVESTIGATOR · Study Principal Investigator
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Presence of Hypertrophic Scarring6 weeks postop
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 Scarring3 months postop
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 Scarring6 months postop
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 Scarring1 year postop
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.
- Scar Characteristics6 weeks postop
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
- Scar characteristics3 months postop
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
- Scar Characteristics6 months postop
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
- Scar Characteristics1 year postop
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
- Scar Dimensions6 weeks postop
Scar Scar length, width and thickness measured in cm. If HTS present: Length of HTS and incision ratio Location of HTS: Medial, Middle, or Lateral. Measured distance from sternum.
- Scar Dimensions3 months postop
Scar Scar length, width and thickness measured in cm. If HTS present: Length of HTS and incision ratio Location of HTS: Medial, Middle, or Lateral. Measured distance from sternum.
- Scar Dimensions6 months postop
Scar Scar length, width and thickness measured in cm. If HTS present: Length of HTS and incision ratio Location of HTS: Medial, Middle, or Lateral. Measured distance from sternum.
- Scar Dimensions1 year postop
Scar Scar length, width and thickness measured in cm. If HTS present: Length of HTS and incision ratio Location of HTS: Medial, Middle, or Lateral. Measured distance from sternum.