Surgical Incision
Conditions
Keywords
Wound Healing
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.
Interventions
DEVICESide 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.
OTHERSide 1: Final layer dermal closure with poliglecaprone 25 suture
Current method of wound closure
DEVICESide 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.
OTHERSide 2: Final layer dermal closure with poliglecaprone 25 suture
Current method of wound closure
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
Intervention model description
Randomization will occur after all the portions of the surgical procedure are completed except for final skin layer closure.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | 12 Months | 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. |
| Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | 6 Months | 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. |
| Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | 3 Months | 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. |
| Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | 3 Months | 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. |
| Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | 12 Months | 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. |
| Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scar Maximum Depth | Week 2, Week 4, Week 6 and Week 8 | eKare will be used to asses scar area |
| Interleukin-8 (IL8) | Baseline, 4 Week, 8 Week, 3 Months, 12 Months | 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 |
| Interleukin-6 (IL6) | Baseline, 4 Week, 8 Week, 3 Months, 12 Months | 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 |
| Measure of the Skins Function | Baseline, 3 Months, 6 Months, and 12 Months | 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 |
| Scar Area Assessment | Week 2, Week 4, Week 6 and Week 8 | eKare will be used to asses scars progression over an 8-week period. The data is an average at each timepoints. |
| Change in Tissue Thickness | Baseline, 3 Months, 6 Months, and 12 Months | Epidermal and Dermis thickness was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin. |
| Change in Tissue Stiffness | Baseline, 3 Months, 6 Months, and 12 Months | Tissue stiffness was measured using the BTC2000 to measure the resistance of the tissue under applied force/pressure. |
| Change in Tissue Energy Absorption | Baseline, 3 Months, 6 Months, and 12 Months | Tissue energy absorption was measured using the BTC2000 to measure the softness of the tissue through the deformation process. |
| Change in Tissue Density | Baseline, 3 Months, 6 Months, and 12 Months | Epidermal and Dermis density was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin. |
| Gene Regulation- Elastin | Baseline, 4 Week, 8 Week, 3 Months, 12 Months | Assessment of mechanical properties of regenerated skin Fold change= sample/average of the baseline |
| Gene Analysis- Macrophage | Baseline, 4 Week, 8 Week, 3 Months, 12 Months | Biopsy will be obtained to assess progression of tissue Fold change= sample/average of the baseline |
| Histology Collagen 3 | Baseline, 4 Week, 8 Week, 3 Months, 12 Months | Biopsy will be obtained to assess early wound healing and ECM formation during scaffold integration Fold change= sample/average of the baseline |
| Change in Mechanical Properties of Human Tissue | Baseline, 3 Months, 6 Months, and 12 Months | 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. |
| Histology Collagen 1 | Baseline, 4 Week, 8 Week, 3 Months, 12 Months | Biopsy will be obtained to assess collagen synthesis, restoring dermal strength and elasticity during regeneration fold change= sample/average of the baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Subjects Subjects consented and treated in the study | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 3 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Study Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 |
| other Total, other adverse events | 1 / 36 | 1 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
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
Population: All subjects received an FTMB and SOC closure on either surgical scar
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | Vascularity | 1.26 score on a scale | Standard Deviation 0.45 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | Pigmentation | 1.74 score on a scale | Standard Deviation 0.81 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | Thickness | 1.70 score on a scale | Standard Deviation 0.88 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | Relief | 1.30 score on a scale | Standard Deviation 0.56 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | Pliability | 1.35 score on a scale | Standard Deviation 0.57 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | Surface Area | 1.35 score on a scale | Standard Deviation 0.57 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | Pliability | 1.57 score on a scale | Standard Deviation 0.73 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | Vascularity | 1.30 score on a scale | Standard Deviation 0.56 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | Relief | 1.57 score on a scale | Standard Deviation 0.79 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | Pigmentation | 2.04 score on a scale | Standard Deviation 0.88 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | Surface Area | 1.78 score on a scale | Standard Deviation 0.85 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M | Thickness | 1.96 score on a scale | Standard Deviation 0.77 |
Primary
Patient and Observer Scar Assessment Scale (POSAS)- Observer 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
Population: All subjects received an FTMB and SOC closure on either surgical scar
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | Vascularity | 1.45 score on a scale | Standard Deviation 0.76 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | Pigmentation | 1.75 score on a scale | Standard Deviation 0.97 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | Thickness | 1.55 score on a scale | Standard Deviation 1 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | Relief | 1.40 score on a scale | Standard Deviation 0.94 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | Pliability | 1.30 score on a scale | Standard Deviation 0.92 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | Surface Area | 1.30 score on a scale | Standard Deviation 0.73 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | Pliability | 1.50 score on a scale | Standard Deviation 0.95 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | Vascularity | 1.70 score on a scale | Standard Deviation 0.73 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | Relief | 1.60 score on a scale | Standard Deviation 0.99 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | Pigmentation | 2.20 score on a scale | Standard Deviation 1.2 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | Surface Area | 1.75 score on a scale | Standard Deviation 0.85 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M | Thickness | 1.90 score on a scale | Standard Deviation 0.97 |
Primary
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
Population: All subjects received an FTMB and SOC closure on either surgical scar
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | Vascularity | 1.47 score on a scale | Standard Deviation 0.77 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | Pigmentation | 1.68 score on a scale | Standard Deviation 0.82 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | Thickness | 1.32 score on a scale | Standard Deviation 0.48 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | Relief | 1.16 score on a scale | Standard Deviation 0.69 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | Pliability | 1.16 score on a scale | Standard Deviation 0.69 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | Surface Area | 1.16 score on a scale | Standard Deviation 0.37 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | Pliability | 1.11 score on a scale | Standard Deviation 0.46 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | Vascularity | 1.53 score on a scale | Standard Deviation 0.77 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | Relief | 1.32 score on a scale | Standard Deviation 0.58 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | Pigmentation | 2.37 score on a scale | Standard Deviation 0.96 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | Surface Area | 1.26 score on a scale | Standard Deviation 0.56 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M | Thickness | 1.63 score on a scale | Standard Deviation 0.68 |
Primary
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
Population: All subjects received an FTMB and SOC closure on either surgical scar
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Thickness | 2.74 score on a scale | Standard Deviation 2.03 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Color | 4.22 score on a scale | Standard Deviation 2.92 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Irregularities | 2.70 score on a scale | Standard Deviation 1.61 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Itchiness | 1.3 score on a scale | Standard Deviation 1.06 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Total Score | 14.22 score on a scale | Standard Deviation 7.25 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Stiffness | 2.17 score on a scale | Standard Deviation 1.61 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Overall Opinion | 3.17 score on a scale | Standard Deviation 1.87 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Pain | 1.09 score on a scale | Standard Deviation 0.42 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Overall Opinion | 3.04 score on a scale | Standard Deviation 2.14 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Itchiness | 1.87 score on a scale | Standard Deviation 1.96 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Color | 1.22 score on a scale | Standard Deviation 0.74 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Stiffness | 2.39 score on a scale | Standard Deviation 1.99 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Thickness | 2.74 score on a scale | Standard Deviation 2.22 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Irregularities | 2.70 score on a scale | Standard Deviation 1.87 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Total Score | 15.22 score on a scale | Standard Deviation 8.63 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M | Pain | 1.22 score on a scale | Standard Deviation 0.74 |
Primary
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
Population: All subjects received an FTMB and SOC closure on either surgical scar
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Pain | 1.30 score on a scale | Standard Deviation 0.8 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Itchiness | 2.40 score on a scale | Standard Deviation 2.11 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Color | 4.55 score on a scale | Standard Deviation 2.78 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Stiffness | 3.8 score on a scale | Standard Deviation 2.97 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Thickness | 3.20 score on a scale | Standard Deviation 2.38 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Irregularities | 3.5 score on a scale | Standard Deviation 2.4 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Total Score | 18.75 score on a scale | Standard Deviation 10.15 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Overall Opinion | 4.15 score on a scale | Standard Deviation 2.46 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Overall Opinion | 4.15 score on a scale | Standard Deviation 2.43 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Pain | 1.30 score on a scale | Standard Deviation 0.66 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Thickness | 3.35 score on a scale | Standard Deviation 2.66 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Itchiness | 2.15 score on a scale | Standard Deviation 1.69 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Total Score | 18.55 score on a scale | Standard Deviation 9.94 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Color | 4.60 score on a scale | Standard Deviation 2.85 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Irregularities | 3.45 score on a scale | Standard Deviation 2.5 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M | Stiffness | 3.75 score on a scale | Standard Deviation 2.84 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Pain | 1.05 score on a scale | Standard Deviation 0.23 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Itchiness | 1.11 score on a scale | Standard Deviation 0.32 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Color | 4.37 score on a scale | Standard Deviation 2.67 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Stiffness | 3.32 score on a scale | Standard Deviation 2.43 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Thickness | 3.95 score on a scale | Standard Deviation 2.66 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Irregularity | 4.16 score on a scale | Standard Deviation 2.67 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Total score | 17.95 score on a scale | Standard Deviation 9.73 |
| FTMB Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Overall Opinion | 3.68 score on a scale | Standard Deviation 2.16 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Overall Opinion | 3.26 score on a scale | Standard Deviation 2.02 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Pain | 1.00 score on a scale | Standard Deviation 0 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Thickness | 3.58 score on a scale | Standard Deviation 2.73 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Itchiness | 1.22 score on a scale | Standard Deviation 0.55 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Total score | 17.53 score on a scale | Standard Deviation 9.98 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Color | 4.53 score on a scale | Standard Deviation 2.99 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Irregularity | 3.95 score on a scale | Standard Deviation 2.72 |
| SOC Scar | Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M | Stiffness | 3.32 score on a scale | Standard Deviation 2.24 |
Secondary
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
Population: Analysis by closure and timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Change in Mechanical Properties of Human Tissue | Elasticity (mm) | 0.97 mm | Standard Deviation 0.48 |
| FTMB Scar | Change in Mechanical Properties of Human Tissue | Maximum Pressure (mm) | 149.70 mm | Standard Deviation 0.56 |
| FTMB Scar | Change in Mechanical Properties of Human Tissue | Laxity (mm) | 1.14 mm | Standard Deviation 0.6 |
| FTMB Scar | Change in Mechanical Properties of Human Tissue | Elastic Deformation (mm) | 1.58 mm | Standard Deviation 0.63 |
| FTMB Scar | Change in Mechanical Properties of Human Tissue | Ultimate Deformation (mm) | 1.64 mm | Standard Deviation 0.63 |
| FTMB Scar | Change in Mechanical Properties of Human Tissue | Viscoelastin Deformation (mm) | .06 mm | Standard Deviation 0.02 |
| SOC Scar | Change in Mechanical Properties of Human Tissue | Elastic Deformation (mm) | 1.56 mm | Standard Deviation 0.41 |
| SOC Scar | Change in Mechanical Properties of Human Tissue | Maximum Pressure (mm) | 149.70 mm | Standard Deviation 0.47 |
| SOC Scar | Change in Mechanical Properties of Human Tissue | Viscoelastin Deformation (mm) | .08 mm | Standard Deviation 0.03 |
| SOC Scar | Change in Mechanical Properties of Human Tissue | Elasticity (mm) | 0.85 mm | Standard Deviation 0.26 |
| SOC Scar | Change in Mechanical Properties of Human Tissue | Laxity (mm) | 0.98 mm | Standard Deviation 0.43 |
| SOC Scar | Change in Mechanical Properties of Human Tissue | Ultimate Deformation (mm) | 1.64 mm | Standard Deviation 0.41 |
| FMTB- Week 8 | Change in Mechanical Properties of Human Tissue | Ultimate Deformation (mm) | 1.91 mm | Standard Deviation 0.41 |
| FMTB- Week 8 | Change in Mechanical Properties of Human Tissue | Elastic Deformation (mm) | 1.82 mm | Standard Deviation 0.41 |
| FMTB- Week 8 | Change in Mechanical Properties of Human Tissue | Laxity (mm) | 1.26 mm | Standard Deviation 0.46 |
| FMTB- Week 8 | Change in Mechanical Properties of Human Tissue | Viscoelastin Deformation (mm) | .08 mm | Standard Deviation 0.02 |
| FMTB- Week 8 | Change in Mechanical Properties of Human Tissue | Elasticity (mm) | 1.07 mm | Standard Deviation 0.34 |
| FMTB- Week 8 | Change in Mechanical Properties of Human Tissue | Maximum Pressure (mm) | 149.58 mm | Standard Deviation 0.51 |
| FMTB- Month 3 | Change in Mechanical Properties of Human Tissue | Ultimate Deformation (mm) | 2.11 mm | Standard Deviation 0.58 |
| FMTB- Month 3 | Change in Mechanical Properties of Human Tissue | Maximum Pressure (mm) | 149.62 mm | Standard Deviation 0.5 |
| FMTB- Month 3 | Change in Mechanical Properties of Human Tissue | Laxity (mm) | 1.53 mm | Standard Deviation 0.59 |
| FMTB- Month 3 | Change in Mechanical Properties of Human Tissue | Elastic Deformation (mm) | 2.02 mm | Standard Deviation 0.58 |
| FMTB- Month 3 | Change in Mechanical Properties of Human Tissue | Viscoelastin Deformation (mm) | .09 mm | Standard Deviation 0.03 |
| FMTB- Month 3 | Change in Mechanical Properties of Human Tissue | Elasticity (mm) | 1.17 mm | Standard Deviation 0.53 |
| FMTB- Month 12 | Change in Mechanical Properties of Human Tissue | Ultimate Deformation (mm) | 1.68 mm | Standard Deviation 0.67 |
| FMTB- Month 12 | Change in Mechanical Properties of Human Tissue | Laxity (mm) | 1.13 mm | Standard Deviation 0.6 |
| FMTB- Month 12 | Change in Mechanical Properties of Human Tissue | Elasticity (mm) | 1.00 mm | Standard Deviation 0.52 |
| FMTB- Month 12 | Change in Mechanical Properties of Human Tissue | Maximum Pressure (mm) | 149.78 mm | Standard Deviation 0.42 |
| FMTB- Month 12 | Change in Mechanical Properties of Human Tissue | Viscoelastin Deformation (mm) | .07 mm | Standard Deviation 0.02 |
| FMTB- Month 12 | Change in Mechanical Properties of Human Tissue | Elastic Deformation (mm) | 1.62 mm | Standard Deviation 0.65 |
| Suture- Baseline | Change in Mechanical Properties of Human Tissue | Elastic Deformation (mm) | 1.66 mm | Standard Deviation 0.49 |
| Suture- Baseline | Change in Mechanical Properties of Human Tissue | Viscoelastin Deformation (mm) | .08 mm | Standard Deviation 0.03 |
| Suture- Baseline | Change in Mechanical Properties of Human Tissue | Laxity (mm) | 1.04 mm | Standard Deviation 0.4 |
| Suture- Baseline | Change in Mechanical Properties of Human Tissue | Ultimate Deformation (mm) | 1.74 mm | Standard Deviation 0.5 |
| Suture- Baseline | Change in Mechanical Properties of Human Tissue | Maximum Pressure (mm) | 149.70 mm | Standard Deviation 0.47 |
| Suture- Baseline | Change in Mechanical Properties of Human Tissue | Elasticity (mm) | 0.89 mm | Standard Deviation 0.38 |
| Sutures- Week 4 | Change in Mechanical Properties of Human Tissue | Viscoelastin Deformation (mm) | .08 mm | Standard Deviation 0.02 |
| Sutures- Week 4 | Change in Mechanical Properties of Human Tissue | Ultimate Deformation (mm) | 1.94 mm | Standard Deviation 0.38 |
| Sutures- Week 4 | Change in Mechanical Properties of Human Tissue | Maximum Pressure (mm) | 149.58 mm | Standard Deviation 0.51 |
| Sutures- Week 4 | Change in Mechanical Properties of Human Tissue | Elastic Deformation (mm) | 1.86 mm | Standard Deviation 0.38 |
| Sutures- Week 4 | Change in Mechanical Properties of Human Tissue | Elasticity (mm) | 1.03 mm | Standard Deviation 0.31 |
| Sutures- Week 4 | Change in Mechanical Properties of Human Tissue | Laxity (mm) | 1.28 mm | Standard Deviation 0.39 |
| Suture- Week 8 | Change in Mechanical Properties of Human Tissue | Viscoelastin Deformation (mm) | .08 mm | Standard Deviation 0.02 |
| Suture- Week 8 | Change in Mechanical Properties of Human Tissue | Elastic Deformation (mm) | 2.07 mm | Standard Deviation 0.54 |
| Suture- Week 8 | Change in Mechanical Properties of Human Tissue | Elasticity (mm) | 1.22 mm | Standard Deviation 0.43 |
| Suture- Week 8 | Change in Mechanical Properties of Human Tissue | Ultimate Deformation (mm) | 2.15 mm | Standard Deviation 0.54 |
| Suture- Week 8 | Change in Mechanical Properties of Human Tissue | Maximum Pressure (mm) | 149.62 mm | Standard Deviation 0.5 |
| Suture- Week 8 | Change in Mechanical Properties of Human Tissue | Laxity (mm) | 1.53 mm | Standard Deviation 0.59 |
Secondary
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
Population: Analysis by closure and timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Change in Tissue Density | Baseline | 81.53 g/cm^3 | Standard Deviation 20.64 |
| FTMB Scar | Change in Tissue Density | 3 Months | 83.37 g/cm^3 | Standard Deviation 16.38 |
| FTMB Scar | Change in Tissue Density | 6 Months | 84.33 g/cm^3 | Standard Deviation 21.15 |
| FTMB Scar | Change in Tissue Density | 12 Months | 78.27 g/cm^3 | Standard Deviation 13.68 |
| SOC Scar | Change in Tissue Density | 3 Months | 28.92 g/cm^3 | Standard Deviation 10.59 |
| SOC Scar | Change in Tissue Density | 6 Months | 23.55 g/cm^3 | Standard Deviation 15.43 |
| SOC Scar | Change in Tissue Density | 12 Months | 18.70 g/cm^3 | Standard Deviation 8.82 |
| SOC Scar | Change in Tissue Density | Baseline | 55.08 g/cm^3 | Standard Deviation 18.4 |
| FMTB- Week 8 | Change in Tissue Density | 6 Months | 84.33 g/cm^3 | Standard Deviation 21.15 |
| FMTB- Week 8 | Change in Tissue Density | 3 Months | 83.37 g/cm^3 | Standard Deviation 16.38 |
| FMTB- Week 8 | Change in Tissue Density | 12 Months | 23.50 g/cm^3 | Standard Deviation 14.38 |
| FMTB- Week 8 | Change in Tissue Density | Baseline | 82.67 g/cm^3 | Standard Deviation 22.28 |
| FMTB- Month 3 | Change in Tissue Density | 12 Months | 20.02 g/cm^3 | Standard Deviation 9.86 |
| FMTB- Month 3 | Change in Tissue Density | 3 Months | 31.87 g/cm^3 | Standard Deviation 13.17 |
| FMTB- Month 3 | Change in Tissue Density | Baseline | 53.53 g/cm^3 | Standard Deviation 21.36 |
| FMTB- Month 3 | Change in Tissue Density | 6 Months | 75.02 g/cm^3 | Standard Deviation 9.4 |
Secondary
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
Population: Analysis by closure and timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Change in Tissue Energy Absorption | Baseline | 66.80 mmHg*mm | Standard Deviation 19.42 |
| FTMB Scar | Change in Tissue Energy Absorption | 6 Months | 81.28 mmHg*mm | Standard Deviation 10.19 |
| FTMB Scar | Change in Tissue Energy Absorption | 12 Months | 85.05 mmHg*mm | Standard Deviation 15.08 |
| FTMB Scar | Change in Tissue Energy Absorption | 3 Months | 77.17 mmHg*mm | Standard Deviation 15.4 |
| SOC Scar | Change in Tissue Energy Absorption | 12 Months | 85.32 mmHg*mm | Standard Deviation 13.8 |
| SOC Scar | Change in Tissue Energy Absorption | Baseline | 69.77 mmHg*mm | Standard Deviation 22.87 |
| SOC Scar | Change in Tissue Energy Absorption | 3 Months | 81.04 mmHg*mm | Standard Deviation 21.15 |
| SOC Scar | Change in Tissue Energy Absorption | 6 Months | 84.57 mmHg*mm | Standard Deviation 13.99 |
Secondary
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
Population: Analysis by closure and timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Change in Tissue Stiffness | Baseline | 232.89 mmHg/mm | Standard Deviation 70.29 |
| FTMB Scar | Change in Tissue Stiffness | 6 Months | 173.03 mmHg/mm | Standard Deviation 19.12 |
| FTMB Scar | Change in Tissue Stiffness | 3 Months | 179.50 mmHg/mm | Standard Deviation 40.27 |
| FTMB Scar | Change in Tissue Stiffness | 12 Months | 170.31 mmHg/mm | Standard Deviation 31.14 |
| SOC Scar | Change in Tissue Stiffness | 3 Months | 185.53 mmHg/mm | Standard Deviation 80.62 |
| SOC Scar | Change in Tissue Stiffness | Baseline | 16991.96 mmHg/mm | Standard Deviation 80448.37 |
| SOC Scar | Change in Tissue Stiffness | 12 Months | 170.23 mmHg/mm | Standard Deviation 30.98 |
| SOC Scar | Change in Tissue Stiffness | 6 Months | 166.90 mmHg/mm | Standard Deviation 30.79 |
Secondary
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
Population: Analysis by closure and timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Change in Tissue Thickness | Baseline | 102.43 um | Standard Deviation 18.7 |
| FTMB Scar | Change in Tissue Thickness | 3 Months | 92.42 um | Standard Deviation 13.31 |
| FTMB Scar | Change in Tissue Thickness | 6 Months | 96.74 um | Standard Deviation 19.09 |
| FTMB Scar | Change in Tissue Thickness | 12 Months | 98.90 um | Standard Deviation 15.23 |
| SOC Scar | Change in Tissue Thickness | 3 Months | 1073.79 um | Standard Deviation 223.75 |
| SOC Scar | Change in Tissue Thickness | 6 Months | 1118.37 um | Standard Deviation 305.19 |
| SOC Scar | Change in Tissue Thickness | 12 Months | 1081.14 um | Standard Deviation 321.27 |
| SOC Scar | Change in Tissue Thickness | Baseline | 1020.87 um | Standard Deviation 237.74 |
| FMTB- Week 8 | Change in Tissue Thickness | 6 Months | 96.74 um | Standard Deviation 19.09 |
| FMTB- Week 8 | Change in Tissue Thickness | 3 Months | 92.42 um | Standard Deviation 13.31 |
| FMTB- Week 8 | Change in Tissue Thickness | 12 Months | 150.70 um | Standard Deviation 197.33 |
| FMTB- Week 8 | Change in Tissue Thickness | Baseline | 102.91 um | Standard Deviation 197.33 |
| FMTB- Month 3 | Change in Tissue Thickness | 12 Months | 1915.65 um | Standard Deviation 3568.82 |
| FMTB- Month 3 | Change in Tissue Thickness | 3 Months | 1073.79 um | Standard Deviation 223.75 |
| FMTB- Month 3 | Change in Tissue Thickness | Baseline | 977.61 um | Standard Deviation 180.79 |
| FMTB- Month 3 | Change in Tissue Thickness | 6 Months | 1118.37 um | Standard Deviation 305.19 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTMB Scar | Gene Analysis- Macrophage | 1.00 fold change | Standard Error 0.18 |
| SOC Scar | Gene Analysis- Macrophage | 0.77 fold change | Standard Error 0.04 |
| FMTB- Week 8 | Gene Analysis- Macrophage | 0.99 fold change | Standard Error 0.1 |
| FMTB- Month 3 | Gene Analysis- Macrophage | 0.98 fold change | Standard Error 0.22 |
| FMTB- Month 12 | Gene Analysis- Macrophage | 0.50 fold change | Standard Error 0.05 |
| Suture- Baseline | Gene Analysis- Macrophage | 1.000 fold change | Standard Error 0.17 |
| Sutures- Week 4 | Gene Analysis- Macrophage | 0.69 fold change | Standard Error 0.14 |
| Suture- Week 8 | Gene Analysis- Macrophage | 1.07 fold change | Standard Error 0.14 |
| Suture Month 3 | Gene Analysis- Macrophage | 0.82 fold change | Standard Error 0.3 |
| Suture- Month 12 | Gene Analysis- Macrophage | 0.56 fold change | Standard Error 0.04 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTMB Scar | Gene Regulation- Elastin | 1.09 fold change | Standard Error 0.16 |
| SOC Scar | Gene Regulation- Elastin | 0.80 fold change | Standard Error 0.09 |
| FMTB- Week 8 | Gene Regulation- Elastin | 1.04 fold change | Standard Error 0.07 |
| FMTB- Month 3 | Gene Regulation- Elastin | 0.82 fold change | Standard Error 0.08 |
| FMTB- Month 12 | Gene Regulation- Elastin | 1.21 fold change | Standard Error 0.33 |
| Suture- Baseline | Gene Regulation- Elastin | 0.92 fold change | Standard Error 0.14 |
| Sutures- Week 4 | Gene Regulation- Elastin | 1.01 fold change | Standard Error 0.07 |
| Suture- Week 8 | Gene Regulation- Elastin | 1.17 fold change | Standard Error 0.09 |
| Suture Month 3 | Gene Regulation- Elastin | 1.21 fold change | Standard Error 0.11 |
| Suture- Month 12 | Gene Regulation- Elastin | 1.22 fold change | Standard Error 0.22 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTMB Scar | Histology Collagen 1 | 1.00 fold change | Standard Error 0.25 |
| SOC Scar | Histology Collagen 1 | 1.02 fold change | Standard Error 0.13 |
| FMTB- Week 8 | Histology Collagen 1 | 0.92 fold change | Standard Error 0.16 |
| FMTB- Month 3 | Histology Collagen 1 | 1.17 fold change | Standard Error 0.2 |
| FMTB- Month 12 | Histology Collagen 1 | 0.92 fold change | Standard Error 0.15 |
| Suture- Baseline | Histology Collagen 1 | 1.00 fold change | Standard Error 0.16 |
| Sutures- Week 4 | Histology Collagen 1 | 0.91 fold change | Standard Error 0.12 |
| Suture- Week 8 | Histology Collagen 1 | 0.97 fold change | Standard Error 0.17 |
| Suture Month 3 | Histology Collagen 1 | 1.18 fold change | Standard Error 0.25 |
| Suture- Month 12 | Histology Collagen 1 | 1.04 fold change | Standard Error 0.07 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTMB Scar | Histology Collagen 3 | 1.11 fold change | Standard Error 0.21 |
| SOC Scar | Histology Collagen 3 | 1.19 fold change | Standard Error 0.22 |
| FMTB- Week 8 | Histology Collagen 3 | 1.13 fold change | Standard Error 0.22 |
| FMTB- Month 3 | Histology Collagen 3 | 1.37 fold change | Standard Error 1.46 |
| FMTB- Month 12 | Histology Collagen 3 | 1.46 fold change | Standard Error 0.11 |
| Suture- Baseline | Histology Collagen 3 | 0.89 fold change | Standard Error 0.14 |
| Sutures- Week 4 | Histology Collagen 3 | 0.89 fold change | Standard Error 0.18 |
| Suture- Week 8 | Histology Collagen 3 | 1.38 fold change | Standard Error 0.22 |
| Suture Month 3 | Histology Collagen 3 | 1.13 fold change | Standard Error 0.31 |
| Suture- Month 12 | Histology Collagen 3 | 1.51 fold change | Standard Error 0.19 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTMB Scar | Interleukin-6 (IL6) | 1.25 fold change | Standard Error 1.19 |
| SOC Scar | Interleukin-6 (IL6) | 2.89 fold change | Standard Error 1.4 |
| FMTB- Week 8 | Interleukin-6 (IL6) | 2.23 fold change | Standard Error 1.69 |
| FMTB- Month 3 | Interleukin-6 (IL6) | 7.96 fold change | Standard Error 2.96 |
| FMTB- Month 12 | Interleukin-6 (IL6) | 0.53 fold change | Standard Error 0.15 |
| Suture- Baseline | Interleukin-6 (IL6) | 5.89 fold change | Standard Error 3.99 |
| Sutures- Week 4 | Interleukin-6 (IL6) | 2.07 fold change | Standard Error 0.06 |
| Suture- Week 8 | Interleukin-6 (IL6) | 2.83 fold change | Standard Error 0.85 |
| Suture Month 3 | Interleukin-6 (IL6) | 5.24 fold change | Standard Error 1.34 |
| Suture- Month 12 | Interleukin-6 (IL6) | 1.75 fold change | Standard Error 1.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FTMB Scar | Interleukin-8 (IL8) | 1.39 fold change | Standard Error 0.51 |
| SOC Scar | Interleukin-8 (IL8) | 30.49 fold change | Standard Error 11.97 |
| FMTB- Week 8 | Interleukin-8 (IL8) | 14.75 fold change | Standard Error 8.29 |
| FMTB- Month 3 | Interleukin-8 (IL8) | 9.38 fold change | Standard Error 3.26 |
| FMTB- Month 12 | Interleukin-8 (IL8) | 0.18 fold change | Standard Error 0.04 |
| Suture- Baseline | Interleukin-8 (IL8) | 1.09 fold change | Standard Error 0.3 |
| Sutures- Week 4 | Interleukin-8 (IL8) | 10.50 fold change | Standard Error 0.58 |
| Suture- Week 8 | Interleukin-8 (IL8) | 0.41 fold change | Standard Error 0.21 |
| Suture Month 3 | Interleukin-8 (IL8) | 13.24 fold change | Standard Error 10.64 |
| Suture- Month 12 | Interleukin-8 (IL8) | 1.13 fold change | Standard Error 0.42 |
Secondary
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
Population: Analysis by closure and timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Measure of the Skins Function | Baseline | 10.01 g/m^2/h | Standard Deviation 4.77 |
| FTMB Scar | Measure of the Skins Function | 3 Months | 10.53 g/m^2/h | Standard Deviation 3.96 |
| FTMB Scar | Measure of the Skins Function | 6 Months | 9.97 g/m^2/h | Standard Deviation 2.89 |
| FTMB Scar | Measure of the Skins Function | 12 Months | 9.03 g/m^2/h | Standard Deviation 3.53 |
| SOC Scar | Measure of the Skins Function | 12 Months | 9.56 g/m^2/h | Standard Deviation 3.41 |
| SOC Scar | Measure of the Skins Function | Baseline | 10.45 g/m^2/h | Standard Deviation 6.84 |
| SOC Scar | Measure of the Skins Function | 6 Months | 9.78 g/m^2/h | Standard Deviation 2.88 |
| SOC Scar | Measure of the Skins Function | 3 Months | 9.64 g/m^2/h | Standard Deviation 2.92 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Scar Area Assessment | Week 2 | 1.61 cm^2 | Standard Error 0.14 |
| FTMB Scar | Scar Area Assessment | Week 6 | 1.57 cm^2 | Standard Error 0.1 |
| FTMB Scar | Scar Area Assessment | Week 4 | 1.69 cm^2 | Standard Error 0.13 |
| FTMB Scar | Scar Area Assessment | Week 8 | 1.25 cm^2 | Standard Error 0.17 |
| FTMB Scar | Scar Area Assessment | Overall | 1.53 cm^2 | Standard Error 0.1 |
| SOC Scar | Scar Area Assessment | Week 8 | 2.63 cm^2 | Standard Error 0.2 |
| SOC Scar | Scar Area Assessment | Overall | 2.16 cm^2 | Standard Error 0.11 |
| SOC Scar | Scar Area Assessment | Week 2 | 2.28 cm^2 | Standard Error 0.2 |
| SOC Scar | Scar Area Assessment | Week 4 | 2.65 cm^2 | Standard Error 0.17 |
| SOC Scar | Scar Area Assessment | Week 6 | 1.93 cm^2 | Standard Error 0.25 |
Secondary
Scar Maximum Depth
eKare will be used to asses scar area
Time frame: Week 2, Week 4, Week 6 and Week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FTMB Scar | Scar Maximum Depth | Week 8 | 0.04 mm | Standard Error 0.02 |
| FTMB Scar | Scar Maximum Depth | Overall | 0.07 mm | Standard Error 0.01 |
| FTMB Scar | Scar Maximum Depth | Week 2 | 0.09 mm | Standard Error 0.01 |
| FTMB Scar | Scar Maximum Depth | Week 4 | 0.07 mm | Standard Error 0.02 |
| FTMB Scar | Scar Maximum Depth | Week 6 | 0.08 mm | Standard Error 0.01 |
| SOC Scar | Scar Maximum Depth | Week 6 | 0.1 mm | Standard Error 0.01 |
| SOC Scar | Scar Maximum Depth | Week 4 | 0.09 mm | Standard Error 0.01 |
| SOC Scar | Scar Maximum Depth | Overall | 0.09 mm | Standard Error 0 |
| SOC Scar | Scar Maximum Depth | Week 8 | 0.09 mm | Standard Error 0.02 |
| SOC Scar | Scar Maximum Depth | Week 2 | 0.10 mm | Standard Error 0 |