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Wound Closure Device

Left chest with Brijjit® FMTB for Mastectomy

N/A
Waitlist Available
Led By Rachel Bluebond-Langner
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months post-surgery visit
Awards & highlights
No Placebo-Only Group

Summary

This trial will test Brijjit® FMTB in patients having double incision gender-affirming mastectomies. The device is used with sutures to improve how scars look and reduce healing issues. One side of the chest will use Brijjit® FMTB, while the other side will use standard care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months post-surgery visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months post-surgery visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Colorimetry of Scar
Cicatrization
Subjective scar evaluation by patient outcomes using POSAS
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Right chest with Brijjit® FMTBExperimental Treatment1 Intervention
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.
Group II: Left chest with Brijjit® FMTBExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,585 Total Patients Enrolled
Rachel Bluebond-LangnerPrincipal InvestigatorNYU Langone Health
~0 spots leftby Nov 2025
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