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

Study Overview
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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

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.

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

Conditions
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Surgical Incision

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomization will occur after all the portions of the surgical procedure are completed except for final skin layer closure.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>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<br>* Current method of wound closure<br>Device: Side 2: Final layer closure with force modulating tissue bridges (FMTB)<br>* Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.<br>* Other names: Brijjit;|
| Other: Group 2<br>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)<br>* Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.<br>* Other names: Brijjit;Other: Side 2: Final layer dermal closure with poliglecaprone 25 suture<br>* Current method of wound closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Observer Scar Assessment Scale (POSAS) | 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 | 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 | 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 | Biopsy will be obtained to assess gene expression. | Baseline, 4 Week, 8 Week, 3 Months, 12 Months | 
| Gene Analysis | Biopsy will be obtained to assess gene expression. | Baseline, 4 Week, 8 Week, 3 Months, 12 Months | 
| Collagen volume/ appearance on pathology | Biopsy will be obtained to assess collagen volume/appearance. | Baseline, 4 Week, 8 Week, 3 Months, 12 Months | 
| Colorimetry | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound Healing