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Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction

NCT05028816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-07-02

Study results available
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Summary

This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern

Conditions

  • Surgical Incision

Interventions

DEVICE

Side 1: Final layer closure with force modulating tissue bridges (FMTB)

Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.

OTHER

Side 1: Final layer dermal closure with poliglecaprone 25 suture

Current method of wound closure

DEVICE

Side 2: Final layer closure with force modulating tissue bridges (FMTB)

Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.

OTHER

Side 2: Final layer dermal closure with poliglecaprone 25 suture

Current method of wound closure

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey Kenkel, MD · Chairman, UT Southwestern

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-05
Primary Completion
2024-04-04
Completion
2024-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05028816 on ClinicalTrials.gov