Brijjit® for Wound Closure in Gender Affirming Mastectomies

Status Withdrawn

Clinical Trial 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

Clinical Trial Description

The hypothesis of this study is that the use of Brijjit® FMTB will result in improved scar outcomes as measured by both patient and treating physician as compared to traditional suture based wound closure methods. As mentioned, at present there is no standard of care for wound closure following double incision GAM, therefore an internal control approach will be taken with patients serving as their own controls. This will be achieved by having one side of the chest receive the of Brijjit® FMTB (intervention) in addition to suture closure of the skin, while the other side will be closed with traditional methods, a combination of sutures and steri-stripsTM (control). ;

Study Design

Related Conditions & MeSH terms

Mastectomy

Clinical Trial Details

NCT number	NCT05368519
Study type	Interventional
Source	NYU Langone Health
Contact
Status	Withdrawn
Phase	N/A
Start date	June 1, 2022
Completion date	April 19, 2024

View Details

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