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Wound Closure Device
Brijjit® for Wound Closure in Gender Affirming Mastectomies
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-months post-surgery visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months post-surgery visit
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 moreAwards & 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
1,413 Previous Clinical Trials
855,750 Total Patients Enrolled
Rachel Bluebond-LangnerPrincipal InvestigatorNYU Langone Health