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Completed

NCT Number: NCT05028816

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

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Key information

Conditions

Surgical Incision Surgical Wound Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center- Outpatient Building

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Brijjit

Side 1: Final layer dermal closure with poliglecaprone 25 suture

Other

Current method of wound closure

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.

Other names: Brijjit

Side 2: Final layer dermal closure with poliglecaprone 25 suture

Other

Current method of wound closure

Primary outcomes

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

    Time frame: 12 Months

    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.

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

    Time frame: 6 Months

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

    Time frame: 3 Months

    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.

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

    Time frame: 3 Months

    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.

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

    Time frame: 12 Months

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

    Time frame: 6 Months

    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.

Secondary outcomes

  1. Scar Area Assessment

    Time frame: Week 2, Week 4, Week 6 and Week 8

    eKare will be used to asses scars progression over an 8-week period.

    The data is an average at each timepoints.

  2. Gene Regulation- Elastin

    Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

    Assessment of mechanical properties of regenerated skin

    Fold change= sample/average of the baseline

  3. Gene Analysis- Macrophage

    Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

    Biopsy will be obtained to assess progression of tissue Fold change= sample/average of the baseline

  4. Histology Collagen 3

    Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

    Biopsy will be obtained to assess early wound healing and ECM formation during scaffold integration Fold change= sample/average of the baseline

  5. Change in Mechanical Properties of Human Tissue

    Time frame: Baseline, 3 Months, 6 Months, and 12 Months

    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.

  6. Histology Collagen 1

    Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

    Biopsy will be obtained to assess collagen synthesis, restoring dermal strength and elasticity during regeneration fold change= sample/average of the baseline

  7. Scar Maximum Depth

    Time frame: Week 2, Week 4, Week 6 and Week 8

    eKare will be used to asses scar area

  8. Interleukin-8 (IL8)

    Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

    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

  9. Interleukin-6 (IL6)

    Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

    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

  10. Measure of the Skins Function

    Time frame: Baseline, 3 Months, 6 Months, and 12 Months

    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

  11. Change in Tissue Density

    Time frame: Baseline, 3 Months, 6 Months, and 12 Months

    Epidermal and Dermis density was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.

  12. Change in Tissue Thickness

    Time frame: Baseline, 3 Months, 6 Months, and 12 Months

    Epidermal and Dermis thickness was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.

  13. Change in Tissue Stiffness

    Time frame: Baseline, 3 Months, 6 Months, and 12 Months

    Tissue stiffness was measured using the BTC2000 to measure the resistance of the tissue under applied force/pressure.

  14. Change in Tissue Energy Absorption

    Time frame: Baseline, 3 Months, 6 Months, and 12 Months

    Tissue energy absorption was measured using the BTC2000 to measure the softness of the tissue through the deformation process.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 31, 2021
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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