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

January 12, 2024 updated by: Jeffrey M. Kenkel, University of Texas Southwestern Medical Center
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

Active, not recruiting

Conditions

Intervention / Treatment

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 (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 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.
8 Weeks, 3 Months, 6 Months and 12 Months
Photographic Assessment
Time Frame: 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.
Baseline, 2 Week, 4 Week, 6 Week, 8 Week, 3 Months, 6 Months and 12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scar Volume/Surface Area
Time Frame: Baseline, 4 Week, 8 Week, 3 Months, 6 Months, and 12 Months
eKare will be used to asses scar volume and surface area.
Baseline, 4 Week, 8 Week, 3 Months, 6 Months, and 12 Months
Gene Regulation
Time Frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Biopsy will be obtained to assess gene expression.
Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Gene Analysis
Time Frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Biopsy will be obtained to assess gene expression.
Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Collagen volume/ appearance on pathology
Time Frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Biopsy will be obtained to assess collagen volume/appearance.
Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Colorimetry
Time Frame: 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
Baseline, 2 Weeks, 4 Weeks, 6 Weeks, 8 Weeks, 3 Months, 6 Months and 12 Months
Length of adherence
Time Frame: 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
Baseline, 2 Weeks, 4 Weeks, 6 Weeks, 8 Weeks, 3 Months, 6 Months and 12 Months
Non-Invasive skin measurements
Time Frame: 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.
Baseline, 4 Week, 8 Week, 3 Months, 6 Months, and 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2021

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

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)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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