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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | 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) |
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| Group 2 | Other | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Side 1: Final layer closure with force modulating tissue bridges (FMTB) | Device | Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 3 Months |
| Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M |
| Measure | Description | Time Frame |
|---|---|---|
| Scar Area Assessment | eKare will be used to asses scars progression over an 8-week period. The data is an average at each timepoints. | Week 2, Week 4, Week 6 and Week 8 |
| Gene Regulation- Elastin |
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Inclusion Criteria:
Exclusion Criteria:
Individuals diagnosed with known allergy to general adhesives/adhesive tape
Individuals with a history of using the following prescription medications:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Kenkel, MD | Chairman, UT Southwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center- Outpatient Building | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FMTB Left/ SOC Right | SOC: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ) Briijt: Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA) |
| FG001 | SOC Left/FMTB Right |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2025 |
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Randomization will occur after all the portions of the surgical procedure are completed except for final skin layer closure.
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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.
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| Side 1: Final layer dermal closure with poliglecaprone 25 suture | Other | Current method of wound closure |
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| Side 2: Final layer closure with force modulating tissue bridges (FMTB) | Device | Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance. |
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| Side 2: Final layer dermal closure with poliglecaprone 25 suture | Other | Current method of wound closure |
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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. |
| 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. | 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. | 6 Months |
Assessment of mechanical properties of regenerated skin
Fold change= sample/average of the baseline
| 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 | 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 | 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. | 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 | Baseline, 4 Week, 8 Week, 3 Months, 12 Months |
| Scar Maximum Depth | eKare will be used to asses scar area | 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 | 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 | 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 | 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. | 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. | 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. | 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. | Baseline, 3 Months, 6 Months, and 12 Months |
SOC: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ) FMTB: Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Subjects | Subjects consented and treated in the study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All subjects received an FTMB and SOC closure on either surgical scar | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
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| 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. | All subjects received an FTMB and SOC closure on either surgical scar | Posted | Mean | Standard Deviation | score on a scale | 3 Months |
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| 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. | All subjects received an FTMB and SOC closure on either surgical scar | Posted | Mean | Standard Deviation | score on a scale | 3 Months |
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| 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. | All subjects received an FTMB and SOC closure on either surgical scar | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
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| 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. | All subjects received an FTMB and SOC closure on either surgical scar | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
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| 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. | Posted | Mean | Standard Error | cm^2 | Week 2, Week 4, Week 6 and Week 8 |
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| Secondary | Gene Regulation- Elastin | Assessment of mechanical properties of regenerated skin Fold change= sample/average of the baseline | Posted | Mean | Standard Error | fold change | Baseline, 4 Week, 8 Week, 3 Months, 12 Months |
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| Secondary | Gene Analysis- Macrophage | Biopsy will be obtained to assess progression of tissue Fold change= sample/average of the baseline | Posted | Mean | Standard Error | fold change | Baseline, 4 Week, 8 Week, 3 Months, 12 Months |
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| 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 | Posted | Mean | Standard Error | fold change | Baseline, 4 Week, 8 Week, 3 Months, 12 Months |
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| 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. | Analysis by closure and timepoints | Posted | Mean | Standard Deviation | mm | Baseline, 3 Months, 6 Months, and 12 Months |
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| 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 | Posted | Mean | Standard Error | fold change | Baseline, 4 Week, 8 Week, 3 Months, 12 Months |
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| Secondary | Scar Maximum Depth | eKare will be used to asses scar area | Posted | Mean | Standard Error | mm | Week 2, Week 4, Week 6 and Week 8 |
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| 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 | Posted | Mean | Standard Error | fold change | Baseline, 4 Week, 8 Week, 3 Months, 12 Months |
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| 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 | Posted | Mean | Standard Error | fold change | Baseline, 4 Week, 8 Week, 3 Months, 12 Months |
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| 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 | Analysis by closure and timepoints | Posted | Mean | Standard Deviation | g/m^2/h | Baseline, 3 Months, 6 Months, and 12 Months |
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| 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. | Analysis by closure and timepoints | Posted | Mean | Standard Deviation | g/cm^3 | Baseline, 3 Months, 6 Months, and 12 Months |
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| 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. | Analysis by closure and timepoints | Posted | Mean | Standard Deviation | um | Baseline, 3 Months, 6 Months, and 12 Months |
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| Secondary | Change in Tissue Stiffness | Tissue stiffness was measured using the BTC2000 to measure the resistance of the tissue under applied force/pressure. | Analysis by closure and timepoints | Posted | Mean | Standard Deviation | mmHg/mm | Baseline, 3 Months, 6 Months, and 12 Months |
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| 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. | Analysis by closure and timepoints | Posted | Mean | Standard Deviation | mmHg*mm | Baseline, 3 Months, 6 Months, and 12 Months |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FMTB | Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA) | 0 | 36 | 0 | 36 | 1 | 36 |
| EG001 | Suture | SOC: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ) | 0 | 36 | 0 | 36 | 1 | 36 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contact Dermititis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Oral Thrush | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Barillas, Research Coordinator | UT Southwestern Department of Plastic Surgery Research | 214-645-8907 | jennifer.bqarillas@utsouthwestern.edu |
| Apr 18, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Color |
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| Stiffness |
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| Thickness |
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| Irregularities |
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| Total Score |
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| Overall Opinion |
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Subjects with standard of care closure
| OG006 | Sutures- Week 4 | Subjects with standard of care closure |
| OG007 | Suture- Week 8 | Subjects with standard of care closure |
| OG008 | Suture Month 3 | Subjects with standard of care closure |
| OG009 | Suture- Month 12 | Subjects with standard of care closure |
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Subjects with standard of care closure
| OG006 | Sutures- Week 4 | Subjects with standard of care closure |
| OG007 | Suture- Week 8 | Subjects with standard of care closure |
| OG008 | Suture Month 3 | Subjects with standard of care closure |
| OG009 | Suture- Month 12 | Subjects with standard of care closure |
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Subjects with standard of care closure |
| OG006 | Sutures- Week 4 | Subjects with standard of care closure |
| OG007 | Suture- Week 8 | Subjects with standard of care closure |
| OG008 | Suture Month 3 | Subjects with standard of care closure |
| OG009 | Suture- Month 12 | Subjects with standard of care closure |
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| OG005 | SOC- 3M | Subjects with standard of care closure |
| OG006 | SOC- 6M | Subjects with standard of care closure |
| OG007 | SOC- 12M | Subjects with standard of care closure |
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Subject received suture closure |
| OG006 | Sutures- Week 4 | Subject received suture closure |
| OG007 | Suture- Week 8 | Subject received suture closure |
| OG008 | Suture Month 3 | Subject received suture closure |
| OG009 | Suture- Month 12 | Subject received suture closure |
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| Suture- Baseline |
Subjects with standard of care closure |
| OG006 | Sutures- Week 4 | Subjects with standard of care closure |
| OG007 | Suture- Week 8 | Subjects with standard of care closure |
| OG008 | Suture Month 3 | Subjects with standard of care closure |
| OG009 | Suture- Month 12 | Subjects with standard of care closure |
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| Suture- Baseline |
Subjects with standard of care closure |
| OG006 | Sutures- Week 4 | Subjects with standard of care closure |
| OG007 | Suture- Week 8 | Subjects with standard of care closure |
| OG008 | Suture Month 3 | Subjects with standard of care closure |
| OG009 | Suture- Month 12 | Subjects with standard of care closure |
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| Participants |
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| Participants |
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