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
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
39
Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.
Current method of wound closure
Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.
UT Southwestern Medical Center- Outpatient Building
Dallas, Texas, United States
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Time frame: 12 Months
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Time frame: 6 Months
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Time frame: 3 Months
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M
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Current method of wound closure
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Time frame: 3 Months
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Time frame: 12 Months
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Time frame: 6 Months
Scar Area Assessment
eKare will be used to asses scars progression over an 8-week period. The data is an average at each timepoints.
Time frame: Week 2, Week 4, Week 6 and Week 8
Gene Regulation- Elastin
Assessment of mechanical properties of regenerated skin Fold change= sample/average of the baseline
Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Gene Analysis- Macrophage
Biopsy will be obtained to assess progression of tissue Fold change= sample/average of the baseline
Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Histology Collagen 3
Biopsy will be obtained to assess early wound healing and ECM formation during scaffold integration Fold change= sample/average of the baseline
Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Change in Mechanical Properties of Human Tissue
BTC2000 is used to assess changes in skin laxity and elasticity in skin that was treated with each closure. Skin maximum pressure, laxity, elastic/viscoelastic/ultimate deformation, and elasticity is measured to track changes through multiple timepoints.
Time frame: Baseline, 3 Months, 6 Months, and 12 Months
Histology Collagen 1
Biopsy will be obtained to assess collagen synthesis, restoring dermal strength and elasticity during regeneration fold change= sample/average of the baseline
Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Scar Maximum Depth
eKare will be used to asses scar area
Time frame: Week 2, Week 4, Week 6 and Week 8
Interleukin-8 (IL8)
IL8 is a small protein called a chemokine that play a crucial role in the body's immune and inflammatory responses. A biopsy will be obtained at different timepoints to assessment changes from baseline. fold change= sample/average of the baseline
Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Interleukin-6 (IL6)
IL6 is an inflammatory cytokineses that measures acute phase response following treatment. A biopsy will be obtained at different timepoints to assessment changes from baseline. fold change= sample/average of the baseline
Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Measure of the Skins Function
TEWL is a skin measurement to objectively measure the skins barrier function. The device measures the rate at which water evaporates from the skins surface
Time frame: Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Density
Epidermal and Dermis density was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.
Time frame: Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Thickness
Epidermal and Dermis thickness was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.
Time frame: Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Stiffness
Tissue stiffness was measured using the BTC2000 to measure the resistance of the tissue under applied force/pressure.
Time frame: Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Energy Absorption
Tissue energy absorption was measured using the BTC2000 to measure the softness of the tissue through the deformation process.
Time frame: Baseline, 3 Months, 6 Months, and 12 Months