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Brijjit® for Wound Closure in Gender Affirming Mastectomies

NCT05368519 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-08-09

No results posted yet for this study

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

Conditions

  • Mastectomy

Interventions

DEVICE

Brijjit®

Brijjit® is a non-invasive device which serves as a force modulating tissues bridges (FMTB) to aid in wound healing. This device used in would closure and serves to modify the mechanical forces on a wound which are implicated in adverse outcomes including scar formation and complications like wound dehiscence. Brijjit® is a flexible device which attaches via adhesive to the tissue on either side of the wound, approximates the tissue and off-loads forces.

Sponsors & Collaborators

Principal Investigators

  • Rachel Bluebond-Langner · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-04-19
Completion
2024-04-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05368519 on ClinicalTrials.gov