Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
Primary Purpose
Surgical Incision
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Side 1: Final layer closure with force modulating tissue bridges (FMTB)
Side 1: Final layer dermal closure with poliglecaprone 25 suture
Side 2: Final layer closure with force modulating tissue bridges (FMTB)
Side 2: Final layer dermal closure with poliglecaprone 25 suture
Sponsored by
About this trial
This is an interventional supportive care trial for Surgical Incision focused on measuring Wound Healing
Eligibility Criteria
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
Sites / Locations
- UT Southwestern Medical Center- Outpatient Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1
Group 2
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Patient and Observer Scar Assessment Scale (POSAS)
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective.
Photographic Assessment
Photographs will be utilized for evaluation of he appearance of surgical scars.
Secondary Outcome Measures
Scar Volume/Surface Area
eKare will be used to asses scar volume and surface area.
Gene Regulation
Biopsy will be obtained to assess gene expression.
Gene Analysis
Biopsy will be obtained to assess gene expression.
Collagen volume/ appearance on pathology
Biopsy will be obtained to assess collagen volume/appearance.
Colorimetry
Tool will utilize realistic human skin tones to assess the coloring of patients scars
Length of adherence
The bridge shields will be assessed at each visit
Non-Invasive skin measurements
Skin measurements (ultrasonography, optical coherence topography, transepidermal water loss, laxity, stiffness, energy absorption, elasticity and deformation values.
Full Information
NCT ID
NCT05028816
First Posted
August 27, 2021
Last Updated
June 5, 2023
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05028816
Brief Title
Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
Official Title
Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
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
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incision
Keywords
Wound Healing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomization will occur after all the portions of the surgical procedure are completed except for final skin layer closure.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Description
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)
Arm Title
Group 2
Arm Type
Other
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Side 1: Final layer closure with force modulating tissue bridges (FMTB)
Other Intervention Name(s)
Brijjit
Intervention Description
Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.
Intervention Type
Other
Intervention Name(s)
Side 1: Final layer dermal closure with poliglecaprone 25 suture
Intervention Description
Current method of wound closure
Intervention Type
Device
Intervention Name(s)
Side 2: Final layer closure with force modulating tissue bridges (FMTB)
Other Intervention Name(s)
Brijjit
Intervention Description
Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.
Intervention Type
Other
Intervention Name(s)
Side 2: Final layer dermal closure with poliglecaprone 25 suture
Intervention Description
Current method of wound closure
Primary Outcome Measure Information:
Title
Patient and Observer Scar Assessment Scale (POSAS)
Description
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective.
Time Frame
8 Weeks, 3 Months, 6 Months and 12 Months
Title
Photographic Assessment
Description
Photographs will be utilized for evaluation of he appearance of surgical scars.
Time Frame
Baseline, 2 Week, 4 Week, 6 Week, 8 Week, 3 Months, 6 Months and 12 Months
Secondary Outcome Measure Information:
Title
Scar Volume/Surface Area
Description
eKare will be used to asses scar volume and surface area.
Time Frame
Baseline, 4 Week, 8 Week, 3 Months, 6 Months, and 12 Months
Title
Gene Regulation
Description
Biopsy will be obtained to assess gene expression.
Time Frame
Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Title
Gene Analysis
Description
Biopsy will be obtained to assess gene expression.
Time Frame
Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Title
Collagen volume/ appearance on pathology
Description
Biopsy will be obtained to assess collagen volume/appearance.
Time Frame
Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Title
Colorimetry
Description
Tool will utilize realistic human skin tones to assess the coloring of patients scars
Time Frame
Baseline, 2 Weeks, 4 Weeks, 6 Weeks, 8 Weeks, 3 Months, 6 Months and 12 Months
Title
Length of adherence
Description
The bridge shields will be assessed at each visit
Time Frame
Baseline, 2 Weeks, 4 Weeks, 6 Weeks, 8 Weeks, 3 Months, 6 Months and 12 Months
Title
Non-Invasive skin measurements
Description
Skin measurements (ultrasonography, optical coherence topography, transepidermal water loss, laxity, stiffness, energy absorption, elasticity and deformation values.
Time Frame
Baseline, 4 Week, 8 Week, 3 Months, 6 Months, and 12 Months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Kenkel, MD
Organizational Affiliation
Chairman, UT Southwestern
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center- Outpatient Building
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
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