NCT05028816

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

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. Subjects will be randomized to the method of closure and wound support of the symmetrical vertical breast incisions. On the intervention side subjects will have FMTBs applied for final layer closure of the vertical breast incision and will continue with repeat application every two weeks for ongoing wound support for a total of 8 weeks of therapy. On the control side standard suture closure and wound dressings will be utilized. Patients will be evaluated at two-week intervals up until 8 weeks post-operative, then will have 3 additional follow up visits at 3-months, 6-months and 12-months post-operatively. The effects of the therapy will be analyzed during the follow up visits through photography, skin assessments and POSAS (Patient and Observer Scar Assessment Scale) results. A subgroup of 10 patients will also undergo biopsies of the area of interest at five time points throughout the study. Primary study outcomes include POSAS results and photographic assessment while secondary outcomes include scar volume/surface area, gene regulation and genetic analysis obtained via biopsies, collagen volume, skin assessments, colorimetry and time of length of adherence of the device.

Conditions

• Surgical Incision

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-05
• Primary completion: 2024-04-04
• Completion: 2024-12-01
• First posted: 2021-08-31
• Last updated: 2025-07-02
• Results posted: 2025-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study