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

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

Study Overview

• Status: Completed
• Conditions: Surgical Incision
• Intervention / Treatment: Other: Side 1: Final layer dermal closure with poliglecaprone 25 suture; Device: Side 2: Final layer closure with force modulating tissue bridges (FMTB); Device: Side 1: Final layer closure with force modulating tissue bridges (FMTB); Other: Side 2: Final layer dermal closure with poliglecaprone 25 suture

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center- Outpatient Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Individuals diagnosed with known allergy to general adhesives/adhesive tape

2. Individuals with a history of using the following prescription medications:

   • Accutane within the past year;
   • Systemic steroid use within the past year
3. Individuals who have significant scarring on the test site/area(s)
4. Individuals with malnutrition
5. Individuals who have a body mass index >35
6. Individual who have a history of radiation therapy
7. Individual who have a history of breast cancer
8. Active smokers
9. Individuals with a disorder known to negatively affect wound healing (e.g. autoimmune disease, connective tissue disease
10. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; 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; 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 Names: Brijjit
Other: Group 2; 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); Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.; Other Names: Brijjit; Other: Side 2: Final layer dermal closure with poliglecaprone 25 suture; Current method of wound closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar Area Assessment	eKare will be used to asses scars progression over an 8-week period. The data is an average at each timepoints.	Week 2, Week 4, Week 6 and Week 8
Gene Regulation- Elastin	Assessment of mechanical properties of regenerated skin Fold change= sample/average of the baseline	Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Gene Analysis- Macrophage	Biopsy will be obtained to assess progression of tissue Fold change= sample/average of the baseline	Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Histology Collagen 3	Biopsy will be obtained to assess early wound healing and ECM formation during scaffold integration Fold change= sample/average of the baseline	Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Change in Mechanical Properties of Human Tissue	BTC2000 is used to assess changes in skin laxity and elasticity in skin that was treated with each closure. Skin maximum pressure, laxity, elastic/viscoelastic/ultimate deformation, and elasticity is measured to track changes through multiple timepoints.	Baseline, 3 Months, 6 Months, and 12 Months
Histology Collagen 1	Biopsy will be obtained to assess collagen synthesis, restoring dermal strength and elasticity during regeneration fold change= sample/average of the baseline	Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Scar Maximum Depth	eKare will be used to asses scar area	Week 2, Week 4, Week 6 and Week 8
Interleukin-8 (IL8)	IL8 is a small protein called a chemokine that play a crucial role in the body's immune and inflammatory responses. A biopsy will be obtained at different timepoints to assessment changes from baseline. fold change= sample/average of the baseline	Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Interleukin-6 (IL6)	IL6 is an inflammatory cytokineses that measures acute phase response following treatment. A biopsy will be obtained at different timepoints to assessment changes from baseline. fold change= sample/average of the baseline	Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Measure of the Skins Function	TEWL is a skin measurement to objectively measure the skins barrier function. The device measures the rate at which water evaporates from the skins surface	Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Density	Epidermal and Dermis density was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.	Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Thickness	Epidermal and Dermis thickness was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.	Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Stiffness	Tissue stiffness was measured using the BTC2000 to measure the resistance of the tissue under applied force/pressure.	Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Energy Absorption	Tissue energy absorption was measured using the BTC2000 to measure the softness of the tissue through the deformation process.	Baseline, 3 Months, 6 Months, and 12 Months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Jeffrey Kenkel, MD, Chairman, UT Southwestern

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Actual): April 4, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Wound Healing
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: STU 2021-0791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No