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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2024-12-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Surgical Incision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomization will occur after all the portions of the surgical procedure are completed except for final skin layer closure.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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)

Group Type OTHER

Side 1: Final layer dermal closure with poliglecaprone 25 suture

Intervention Type OTHER

Current method of wound closure

Side 2: Final layer closure with force modulating tissue bridges (FMTB)

Intervention Type DEVICE

Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.

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)

Group Type OTHER

Side 1: Final layer closure with force modulating tissue bridges (FMTB)

Intervention Type DEVICE

Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.

Side 2: Final layer dermal closure with poliglecaprone 25 suture

Intervention Type OTHER

Current method of wound closure

Interventions

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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.

Intervention Type DEVICE

Side 1: Final layer dermal closure with poliglecaprone 25 suture

Current method of wound closure

Intervention Type OTHER

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.

Intervention Type DEVICE

Side 2: Final layer dermal closure with poliglecaprone 25 suture

Current method of wound closure

Intervention Type OTHER

Other Intervention Names

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Brijjit Brijjit

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes