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

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05028816
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
20.8
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Side 1: Final layer closure with force modulating tissue bridges (FMTB)
  • Other: Side 1: Final layer dermal closure with poliglecaprone 25 suture
  • Device: Side 2: Final layer closure with force modulating tissue bridges (FMTB)
  • Other: Side 2: Final layer dermal closure with poliglecaprone 25 suture
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomization will occur after all the portions of the surgical procedure are completed except for final skin layer closure.Randomization will occur after all the portions of the surgical procedure are completed except for final skin layer closure.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Supportive Care
Official Title:
Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
Actual Study Start Date :
Oct 5, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Patient and Observer Scar Assessment Scale (POSAS) [8 Weeks, 3 Months, 6 Months and 12 Months]

      Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective.

    2. Photographic Assessment [Baseline, 2 Week, 4 Week, 6 Week, 8 Week, 3 Months, 6 Months and 12 Months]

      Photographs will be utilized for evaluation of he appearance of surgical scars.

    Secondary Outcome Measures

    1. Scar Volume/Surface Area [Baseline, 4 Week, 8 Week, 3 Months, 6 Months, and 12 Months]

      eKare will be used to asses scar volume and surface area.

    2. Gene Regulation [Baseline, 4 Week, 8 Week, 3 Months, 12 Months]

      Biopsy will be obtained to assess gene expression.

    3. Gene Analysis [Baseline, 4 Week, 8 Week, 3 Months, 12 Months]

      Biopsy will be obtained to assess gene expression.

    4. Collagen volume/ appearance on pathology [Baseline, 4 Week, 8 Week, 3 Months, 12 Months]

      Biopsy will be obtained to assess collagen volume/appearance.

    5. Colorimetry [Baseline, 2 Weeks, 4 Weeks, 6 Weeks, 8 Weeks, 3 Months, 6 Months and 12 Months]

      Tool will utilize realistic human skin tones to assess the coloring of patients scars

    6. Length of adherence [Baseline, 2 Weeks, 4 Weeks, 6 Weeks, 8 Weeks, 3 Months, 6 Months and 12 Months]

      The bridge shields will be assessed at each visit

    7. Non-Invasive skin measurements [Baseline, 4 Week, 8 Week, 3 Months, 6 Months, and 12 Months]

      Skin measurements (ultrasonography, optical coherence topography, transepidermal water loss, laxity, stiffness, energy absorption, elasticity and deformation values.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    1. Individuals who have significant scarring on the test site/area(s)

    2. Individuals with malnutrition

    3. Individuals who have a body mass index >35

    4. Individual who have a history of radiation therapy

    5. Individual who have a history of breast cancer

    6. Active smokers

    7. Individuals with a disorder known to negatively affect wound healing (e.g. autoimmune disease, connective tissue disease

    8. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UT Southwestern Medical Center- Outpatient Building Dallas Texas United States 75390

    Sponsors and Collaborators

    • University of Texas Southwestern Medical Center

    Investigators

    • Principal Investigator: Jeffrey Kenkel, MD, Chairman, UT Southwestern

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeffrey M. Kenkel, Professor of Medicine, University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT05028816
    Other Study ID Numbers:
    • STU 2021-0791
    First Posted:
    Aug 31, 2021
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Jeffrey M. Kenkel, Professor of Medicine, University of Texas Southwestern Medical Center
    Wound Healing
    Additional relevant MeSH terms:
    Surgical Wound

    Study Results

    No Results Posted as of Jan 28, 2022