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

NCT05028816 | Completed Results FDA Device

• 1 other identifier: STU 2021-0791
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Wound Healing

Outcome Measures

Primary Outcomes (6)

• Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M

  Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

  12 Months

• Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M

  Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

  6 Months

• Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M

  Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

  3 Months

• Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M

  Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

  3 Months

• Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M

  Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

  12 Months

• Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M

  Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.

  6 Months

Secondary Outcomes (14)

• Scar Area Assessment

  Week 2, Week 4, Week 6 and Week 8

• Gene Regulation- Elastin

  Baseline, 4 Week, 8 Week, 3 Months, 12 Months

• Gene Analysis- Macrophage

  Baseline, 4 Week, 8 Week, 3 Months, 12 Months

• Histology Collagen 3

  Baseline, 4 Week, 8 Week, 3 Months, 12 Months

• Change in Mechanical Properties of Human Tissue

  Baseline, 3 Months, 6 Months, and 12 Months

Study Arms (2)

Group 1

OTHER

Side 1: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ) Side 2: Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA)

Other: Side 1: Final layer dermal closure with poliglecaprone 25 suture; Device: Side 2: Final layer closure with force modulating tissue bridges (FMTB)

Group 2

OTHER

Side 1: Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA) Side 2: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ)

Device: Side 1: Final layer closure with force modulating tissue bridges (FMTB); Other: Side 2: Final layer dermal closure with poliglecaprone 25 suture

Interventions

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

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

Also known as: Brijjit

Group 2

Side 1: Final layer dermal closure with poliglecaprone 25 suture OTHER

Current method of wound closure

Group 1

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

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

Also known as: Brijjit

Group 1

Side 2: Final layer dermal closure with poliglecaprone 25 suture OTHER

Current method of wound closure

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult females 18-65 years of age
• Planned procedure is bilateral breast reduction with modified Wise (anchor, inverted "T") scar pattern.
• Ability to adhere wound therapy after surgery for 8 weeks or have a willing family member/partner to assist with wound therapy care.
• Willing to follow wound care therapy as instructed by study staff.
• Willing to return for follow up visits and undergo study evaluations.

You may not qualify if:

• Individuals diagnosed with known allergy to general adhesives/adhesive tape
• Individuals with a history of using the following prescription medications:
• Accutane within the past year;
• Systemic steroid use within the past year
• Individuals who have significant scarring on the test site/area(s)
• Individuals with malnutrition
• Individuals who have a body mass index \>35
• Individual who have a history of radiation therapy
• Individual who have a history of breast cancer
• Active smokers
• Individuals with a disorder known to negatively affect wound healing (e.g. autoimmune disease, connective tissue disease
• Individual who have an observable pre-operative or intra-operative breast asymmetry that, in the investigators opinion, would interfere with the evaluation of the efficacy of the wound therapy

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center- Outpatient Building

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Jennifer Barillas, Research Coordinator
• Organization: UT Southwestern Department of Plastic Surgery Research

jennifer.bqarillas@utsouthwestern.edu

214-645-8907

Study Officials

• Jeffrey Kenkel, MD

  Chairman, UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be unknown to PI and additional care providers until an envelope is opened by research staff at the time of final layer closure in the OR.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Randomization will occur after all the portions of the surgical procedure are completed except for final skin layer closure.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: August 31, 2021
• Study Start: October 5, 2021
• Primary Completion: April 4, 2024
• Study Completion: December 1, 2024
• Last Updated: July 2, 2025
• Results First Posted: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)