Trial Outcomes & Findings for Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction (NCT NCT05028816)

NCT ID: NCT05028816

Last Updated: 2025-07-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2025-07-02

Participant Flow

Participant milestones

Measure	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)	SOC Left/FMTB Right 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)
Overall Study STARTED	20	16
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	10	4

Reasons for withdrawal

Measure	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)	SOC Left/FMTB Right 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)
Overall Study Lost to Follow-up	5	3
Overall Study Withdrawal by Subject	4	1
Overall Study Physician Decision	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Study Subjects n=36 Participants Subjects consented and treated in the study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: All subjects received an FTMB and SOC closure on either surgical scar

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.

Outcome measures

Measure	FTMB Scar n=23 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=20 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 Subjects with FMTB closure	FMTB- Month 3 Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M Pain	1.09 score on a scale Standard Deviation 0.42	1.22 score on a scale Standard Deviation 0.74	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M Itchiness	1.3 score on a scale Standard Deviation 1.06	1.87 score on a scale Standard Deviation 1.96	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M Thickness	2.74 score on a scale Standard Deviation 2.03	2.74 score on a scale Standard Deviation 2.22	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M Irregularities	2.70 score on a scale Standard Deviation 1.61	2.70 score on a scale Standard Deviation 1.87	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M Overall Opinion	3.17 score on a scale Standard Deviation 1.87	3.04 score on a scale Standard Deviation 2.14	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M Color	4.22 score on a scale Standard Deviation 2.92	1.22 score on a scale Standard Deviation 0.74	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M Stiffness	2.17 score on a scale Standard Deviation 1.61	2.39 score on a scale Standard Deviation 1.99	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M Total Score	14.22 score on a scale Standard Deviation 7.25	15.22 score on a scale Standard Deviation 8.63	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	FTMB Scar n=20 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=20 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 Subjects with FMTB closure	FMTB- Month 3 Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M Itchiness	1.11 score on a scale Standard Deviation 0.32	1.22 score on a scale Standard Deviation 0.55	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M Color	4.37 score on a scale Standard Deviation 2.67	4.53 score on a scale Standard Deviation 2.99	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M Thickness	3.95 score on a scale Standard Deviation 2.66	3.58 score on a scale Standard Deviation 2.73	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M Total score	17.95 score on a scale Standard Deviation 9.73	17.53 score on a scale Standard Deviation 9.98	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M Overall Opinion	3.68 score on a scale Standard Deviation 2.16	3.26 score on a scale Standard Deviation 2.02	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M Pain	1.05 score on a scale Standard Deviation 0.23	1.00 score on a scale Standard Deviation 0	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M Stiffness	3.32 score on a scale Standard Deviation 2.43	3.32 score on a scale Standard Deviation 2.24	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M Irregularity	4.16 score on a scale Standard Deviation 2.67	3.95 score on a scale Standard Deviation 2.72	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 3 Months

Population: All subjects received an FTMB and SOC closure on either surgical scar

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.

Outcome measures

Measure	FTMB Scar n=20 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=20 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 Subjects with FMTB closure	FMTB- Month 3 Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M Pain	1.30 score on a scale Standard Deviation 0.8	1.30 score on a scale Standard Deviation 0.66	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M Itchiness	2.40 score on a scale Standard Deviation 2.11	2.15 score on a scale Standard Deviation 1.69	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M Color	4.55 score on a scale Standard Deviation 2.78	4.60 score on a scale Standard Deviation 2.85	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M Stiffness	3.8 score on a scale Standard Deviation 2.97	3.75 score on a scale Standard Deviation 2.84	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M Thickness	3.20 score on a scale Standard Deviation 2.38	3.35 score on a scale Standard Deviation 2.66	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M Irregularities	3.5 score on a scale Standard Deviation 2.4	3.45 score on a scale Standard Deviation 2.5	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M Total Score	18.75 score on a scale Standard Deviation 10.15	18.55 score on a scale Standard Deviation 9.94	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M Overall Opinion	4.15 score on a scale Standard Deviation 2.46	4.15 score on a scale Standard Deviation 2.43	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 3 Months

Population: All subjects received an FTMB and SOC closure on either surgical scar

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.

Outcome measures

Measure	FTMB Scar n=20 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=20 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 Subjects with FMTB closure	FMTB- Month 3 Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M Vascularity	1.45 score on a scale Standard Deviation 0.76	1.70 score on a scale Standard Deviation 0.73	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M Pigmentation	1.75 score on a scale Standard Deviation 0.97	2.20 score on a scale Standard Deviation 1.20	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M Thickness	1.55 score on a scale Standard Deviation 1	1.90 score on a scale Standard Deviation 0.97	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M Relief	1.40 score on a scale Standard Deviation 0.94	1.60 score on a scale Standard Deviation 0.99	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M Pliability	1.30 score on a scale Standard Deviation 0.92	1.50 score on a scale Standard Deviation 0.95	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M Surface Area	1.30 score on a scale Standard Deviation 0.73	1.75 score on a scale Standard Deviation 0.85	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 Months

Population: All subjects received an FTMB and SOC closure on either surgical scar

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.

Outcome measures

Measure	FTMB Scar n=23 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=23 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 Subjects with FMTB closure	FMTB- Month 3 Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M Vascularity	1.26 score on a scale Standard Deviation 0.45	1.30 score on a scale Standard Deviation 0.56	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M Pigmentation	1.74 score on a scale Standard Deviation 0.81	2.04 score on a scale Standard Deviation 0.88	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M Thickness	1.70 score on a scale Standard Deviation 0.88	1.96 score on a scale Standard Deviation 0.77	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M Relief	1.30 score on a scale Standard Deviation 0.56	1.57 score on a scale Standard Deviation 0.79	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M Pliability	1.35 score on a scale Standard Deviation 0.57	1.57 score on a scale Standard Deviation 0.73	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M Surface Area	1.35 score on a scale Standard Deviation 0.57	1.78 score on a scale Standard Deviation 0.85	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 6 Months

Population: All subjects received an FTMB and SOC closure on either surgical scar

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.

Outcome measures

Measure	FTMB Scar n=20 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=20 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 Subjects with FMTB closure	FMTB- Month 3 Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M Relief	1.16 score on a scale Standard Deviation 0.69	1.32 score on a scale Standard Deviation 0.58	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M Vascularity	1.47 score on a scale Standard Deviation 0.77	1.53 score on a scale Standard Deviation 0.77	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M Pigmentation	1.68 score on a scale Standard Deviation 0.82	2.37 score on a scale Standard Deviation 0.96	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M Thickness	1.32 score on a scale Standard Deviation 0.48	1.63 score on a scale Standard Deviation 0.68	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M Pliability	1.16 score on a scale Standard Deviation 0.69	1.11 score on a scale Standard Deviation 0.46	—	—	—	—	—	—	—	—
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M Surface Area	1.16 score on a scale Standard Deviation 0.37	1.26 score on a scale Standard Deviation 0.56	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	FTMB Scar n=18 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=18 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 Subjects with FMTB closure	FMTB- Month 3 Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Scar Area Assessment Overall	1.53 cm^2 Standard Error 0.10	2.16 cm^2 Standard Error 0.11	—	—	—	—	—	—	—	—
Scar Area Assessment Week 2	1.61 cm^2 Standard Error 0.14	2.28 cm^2 Standard Error 0.20	—	—	—	—	—	—	—	—
Scar Area Assessment Week 4	1.69 cm^2 Standard Error 0.13	2.65 cm^2 Standard Error 0.17	—	—	—	—	—	—	—	—
Scar Area Assessment Week 6	1.57 cm^2 Standard Error 0.10	1.93 cm^2 Standard Error 0.25	—	—	—	—	—	—	—	—
Scar Area Assessment Week 8	1.25 cm^2 Standard Error 0.17	2.63 cm^2 Standard Error 0.20	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 4 Week, 8 Week, 3 Months, 12 Months

Assessment of mechanical properties of regenerated skin

Fold change= sample/average of the baseline

Outcome measures

Measure	FTMB Scar n=11 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=6 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 n=9 Participants Subjects with FMTB closure	FMTB- Month 3 n=9 Participants Subjects with FMTB closure	FMTB- Month 12 n=5 Participants Subjects with FMTB closure	Suture- Baseline n=11 Participants Subjects with standard of care closure	Sutures- Week 4 n=6 Participants Subjects with standard of care closure	Suture- Week 8 n=9 Participants Subjects with standard of care closure	Suture Month 3 n=9 Participants Subjects with standard of care closure	Suture- Month 12 n=5 Participants Subjects with standard of care closure
Gene Regulation- Elastin	1.09 fold change Standard Error 0.16	0.80 fold change Standard Error 0.09	1.04 fold change Standard Error 0.07	0.82 fold change Standard Error 0.08	1.21 fold change Standard Error 0.33	0.92 fold change Standard Error 0.14	1.01 fold change Standard Error 0.07	1.17 fold change Standard Error 0.09	1.21 fold change Standard Error 0.11	1.22 fold change Standard Error 0.22

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	FTMB Scar n=11 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=6 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 n=9 Participants Subjects with FMTB closure	FMTB- Month 3 n=9 Participants Subjects with FMTB closure	FMTB- Month 12 n=5 Participants Subjects with FMTB closure	Suture- Baseline n=11 Participants Subjects with standard of care closure	Sutures- Week 4 n=6 Participants Subjects with standard of care closure	Suture- Week 8 n=9 Participants Subjects with standard of care closure	Suture Month 3 n=9 Participants Subjects with standard of care closure	Suture- Month 12 n=5 Participants Subjects with standard of care closure
Gene Analysis- Macrophage	1.00 fold change Standard Error 0.18	0.77 fold change Standard Error 0.04	0.99 fold change Standard Error 0.10	0.98 fold change Standard Error 0.22	0.50 fold change Standard Error 0.05	1.000 fold change Standard Error 0.17	0.69 fold change Standard Error 0.14	1.07 fold change Standard Error 0.14	0.82 fold change Standard Error 0.30	0.56 fold change Standard Error 0.04

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	FTMB Scar n=11 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=6 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 n=9 Participants Subjects with FMTB closure	FMTB- Month 3 n=9 Participants Subjects with FMTB closure	FMTB- Month 12 n=5 Participants Subjects with FMTB closure	Suture- Baseline n=11 Participants Subjects with standard of care closure	Sutures- Week 4 n=6 Participants Subjects with standard of care closure	Suture- Week 8 n=9 Participants Subjects with standard of care closure	Suture Month 3 n=9 Participants Subjects with standard of care closure	Suture- Month 12 n=5 Participants Subjects with standard of care closure
Histology Collagen 3	1.11 fold change Standard Error 0.21	1.19 fold change Standard Error 0.22	1.13 fold change Standard Error 0.22	1.37 fold change Standard Error 1.46	1.46 fold change Standard Error 0.11	0.89 fold change Standard Error 0.14	0.89 fold change Standard Error 0.18	1.38 fold change Standard Error 0.22	1.13 fold change Standard Error 0.31	1.51 fold change Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline, 3 Months, 6 Months, and 12 Months

Population: Analysis by closure and timepoints

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.

Outcome measures

Measure	FTMB Scar n=23 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=20 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 n=20 Participants Subjects with FMTB closure	FMTB- Month 3 n=23 Participants Subjects with FMTB closure	FMTB- Month 12 n=23 Participants Subjects with FMTB closure	Suture- Baseline n=20 Participants Subjects with standard of care closure	Sutures- Week 4 n=20 Participants Subjects with standard of care closure	Suture- Week 8 n=23 Participants Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Change in Mechanical Properties of Human Tissue Maximum Pressure (mm)	149.70 mm Standard Deviation 0.56	149.70 mm Standard Deviation 0.47	149.58 mm Standard Deviation 0.51	149.62 mm Standard Deviation 0.50	149.78 mm Standard Deviation 0.42	149.70 mm Standard Deviation 0.47	149.58 mm Standard Deviation 0.51	149.62 mm Standard Deviation 0.50	—	—
Change in Mechanical Properties of Human Tissue Laxity (mm)	1.14 mm Standard Deviation 0.60	0.98 mm Standard Deviation 0.43	1.26 mm Standard Deviation 0.46	1.53 mm Standard Deviation 0.59	1.13 mm Standard Deviation 0.60	1.04 mm Standard Deviation 0.4	1.28 mm Standard Deviation 0.39	1.53 mm Standard Deviation 0.59	—	—
Change in Mechanical Properties of Human Tissue Elastic Deformation (mm)	1.58 mm Standard Deviation 0.63	1.56 mm Standard Deviation 0.41	1.82 mm Standard Deviation 0.41	2.02 mm Standard Deviation 0.58	1.62 mm Standard Deviation 0.65	1.66 mm Standard Deviation 0.49	1.86 mm Standard Deviation 0.38	2.07 mm Standard Deviation 0.54	—	—
Change in Mechanical Properties of Human Tissue Viscoelastin Deformation (mm)	.06 mm Standard Deviation .02	.08 mm Standard Deviation .03	.08 mm Standard Deviation .02	.09 mm Standard Deviation .03	.07 mm Standard Deviation .02	.08 mm Standard Deviation .03	.08 mm Standard Deviation .02	.08 mm Standard Deviation .02	—	—
Change in Mechanical Properties of Human Tissue Ultimate Deformation (mm)	1.64 mm Standard Deviation 0.63	1.64 mm Standard Deviation 0.41	1.91 mm Standard Deviation 0.41	2.11 mm Standard Deviation 0.58	1.68 mm Standard Deviation 0.67	1.74 mm Standard Deviation 0.50	1.94 mm Standard Deviation 0.38	2.15 mm Standard Deviation 0.54	—	—
Change in Mechanical Properties of Human Tissue Elasticity (mm)	0.97 mm Standard Deviation 0.48	0.85 mm Standard Deviation 0.26	1.07 mm Standard Deviation 0.34	1.17 mm Standard Deviation 0.53	1.00 mm Standard Deviation 0.52	0.89 mm Standard Deviation 0.38	1.03 mm Standard Deviation 0.31	1.22 mm Standard Deviation 0.43	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	FTMB Scar n=11 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=6 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 n=9 Participants Subjects with FMTB closure	FMTB- Month 3 n=9 Participants Subjects with FMTB closure	FMTB- Month 12 n=5 Participants Subjects with FMTB closure	Suture- Baseline n=11 Participants Subjects with standard of care closure	Sutures- Week 4 n=6 Participants Subjects with standard of care closure	Suture- Week 8 n=9 Participants Subjects with standard of care closure	Suture Month 3 n=9 Participants Subjects with standard of care closure	Suture- Month 12 n=5 Participants Subjects with standard of care closure
Histology Collagen 1	1.00 fold change Standard Error 0.25	1.02 fold change Standard Error 0.13	0.92 fold change Standard Error 0.16	1.17 fold change Standard Error 0.20	0.92 fold change Standard Error 0.15	1.00 fold change Standard Error 0.16	0.91 fold change Standard Error 0.12	0.97 fold change Standard Error 0.17	1.18 fold change Standard Error 0.25	1.04 fold change Standard Error 0.07

SECONDARY outcome

Timeframe: Week 2, Week 4, Week 6 and Week 8

eKare will be used to asses scar area

Outcome measures

Measure	FTMB Scar n=18 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=18 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 Subjects with FMTB closure	FMTB- Month 3 Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Scar Maximum Depth Overall	0.07 mm Standard Error 0.01	0.09 mm Standard Error 0.00	—	—	—	—	—	—	—	—
Scar Maximum Depth Week 2	0.09 mm Standard Error 0.01	0.10 mm Standard Error 0.00	—	—	—	—	—	—	—	—
Scar Maximum Depth Week 4	0.07 mm Standard Error 0.02	0.09 mm Standard Error 0.01	—	—	—	—	—	—	—	—
Scar Maximum Depth Week 6	0.08 mm Standard Error 0.01	0.1 mm Standard Error 0.01	—	—	—	—	—	—	—	—
Scar Maximum Depth Week 8	0.04 mm Standard Error 0.02	0.09 mm Standard Error 0.02	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	FTMB Scar n=11 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=6 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 n=9 Participants Subjects with FMTB closure	FMTB- Month 3 n=9 Participants Subjects with FMTB closure	FMTB- Month 12 n=5 Participants Subjects with FMTB closure	Suture- Baseline n=11 Participants Subjects with standard of care closure	Sutures- Week 4 n=6 Participants Subjects with standard of care closure	Suture- Week 8 n=9 Participants Subjects with standard of care closure	Suture Month 3 n=9 Participants Subjects with standard of care closure	Suture- Month 12 n=5 Participants Subjects with standard of care closure
Interleukin-8 (IL8)	1.39 fold change Standard Error 0.51	30.49 fold change Standard Error 11.97	14.75 fold change Standard Error 8.29	9.38 fold change Standard Error 3.26	0.18 fold change Standard Error 0.04	1.09 fold change Standard Error 0.30	10.50 fold change Standard Error 0.58	0.41 fold change Standard Error 0.21	13.24 fold change Standard Error 10.64	1.13 fold change Standard Error 0.42

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	FTMB Scar n=11 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=6 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 n=9 Participants Subjects with FMTB closure	FMTB- Month 3 n=9 Participants Subjects with FMTB closure	FMTB- Month 12 n=5 Participants Subjects with FMTB closure	Suture- Baseline n=11 Participants Subjects with standard of care closure	Sutures- Week 4 n=6 Participants Subjects with standard of care closure	Suture- Week 8 n=9 Participants Subjects with standard of care closure	Suture Month 3 n=9 Participants Subjects with standard of care closure	Suture- Month 12 n=5 Participants Subjects with standard of care closure
Interleukin-6 (IL6)	1.25 fold change Standard Error 1.19	2.89 fold change Standard Error 1.40	2.23 fold change Standard Error 1.69	7.96 fold change Standard Error 2.96	0.53 fold change Standard Error 0.15	5.89 fold change Standard Error 3.99	2.07 fold change Standard Error 0.06	2.83 fold change Standard Error 0.85	5.24 fold change Standard Error 1.34	1.75 fold change Standard Error 1.10

SECONDARY outcome

Timeframe: Baseline, 3 Months, 6 Months, and 12 Months

Population: Analysis by closure and timepoints

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

Outcome measures

Measure	FTMB Scar n=23 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=23 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 Subjects with FMTB closure	FMTB- Month 3 Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Measure of the Skins Function Baseline	10.01 g/m^2/h Standard Deviation 4.77	10.45 g/m^2/h Standard Deviation 6.84	—	—	—	—	—	—	—	—
Measure of the Skins Function 3 Months	10.53 g/m^2/h Standard Deviation 3.96	9.64 g/m^2/h Standard Deviation 2.92	—	—	—	—	—	—	—	—
Measure of the Skins Function 6 Months	9.97 g/m^2/h Standard Deviation 2.89	9.78 g/m^2/h Standard Deviation 2.88	—	—	—	—	—	—	—	—
Measure of the Skins Function 12 Months	9.03 g/m^2/h Standard Deviation 3.53	9.56 g/m^2/h Standard Deviation 3.41	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 3 Months, 6 Months, and 12 Months

Population: Analysis by closure and timepoints

Epidermal and Dermis density was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.

Outcome measures

Measure	FTMB Scar n=23 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=20 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 n=23 Participants Subjects with FMTB closure	FMTB- Month 3 n=20 Participants Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Change in Tissue Density 12 Months	78.27 g/cm^3 Standard Deviation 13.68	18.70 g/cm^3 Standard Deviation 8.82	23.50 g/cm^3 Standard Deviation 14.38	20.02 g/cm^3 Standard Deviation 9.86	—	—	—	—	—	—
Change in Tissue Density Baseline	81.53 g/cm^3 Standard Deviation 20.64	55.08 g/cm^3 Standard Deviation 18.40	82.67 g/cm^3 Standard Deviation 22.28	53.53 g/cm^3 Standard Deviation 21.36	—	—	—	—	—	—
Change in Tissue Density 3 Months	83.37 g/cm^3 Standard Deviation 16.38	28.92 g/cm^3 Standard Deviation 10.59	83.37 g/cm^3 Standard Deviation 16.38	31.87 g/cm^3 Standard Deviation 13.17	—	—	—	—	—	—
Change in Tissue Density 6 Months	84.33 g/cm^3 Standard Deviation 21.15	23.55 g/cm^3 Standard Deviation 15.43	84.33 g/cm^3 Standard Deviation 21.15	75.02 g/cm^3 Standard Deviation 9.40	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 3 Months, 6 Months, and 12 Months

Population: Analysis by closure and timepoints

Epidermal and Dermis thickness was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.

Outcome measures

Measure	FTMB Scar n=23 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=20 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 n=23 Participants Subjects with FMTB closure	FMTB- Month 3 n=20 Participants Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Change in Tissue Thickness Baseline	102.43 um Standard Deviation 18.70	1020.87 um Standard Deviation 237.74	102.91 um Standard Deviation 197.33	977.61 um Standard Deviation 180.79	—	—	—	—	—	—
Change in Tissue Thickness 3 Months	92.42 um Standard Deviation 13.31	1073.79 um Standard Deviation 223.75	92.42 um Standard Deviation 13.31	1073.79 um Standard Deviation 223.75	—	—	—	—	—	—
Change in Tissue Thickness 6 Months	96.74 um Standard Deviation 19.09	1118.37 um Standard Deviation 305.19	96.74 um Standard Deviation 19.09	1118.37 um Standard Deviation 305.19	—	—	—	—	—	—
Change in Tissue Thickness 12 Months	98.90 um Standard Deviation 15.23	1081.14 um Standard Deviation 321.27	150.70 um Standard Deviation 197.33	1915.65 um Standard Deviation 3568.82	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 3 Months, 6 Months, and 12 Months

Population: Analysis by closure and timepoints

Tissue stiffness was measured using the BTC2000 to measure the resistance of the tissue under applied force/pressure.

Outcome measures

Measure	FTMB Scar n=23 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=23 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 Subjects with FMTB closure	FMTB- Month 3 Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Change in Tissue Stiffness 3 Months	179.50 mmHg/mm Standard Deviation 40.27	185.53 mmHg/mm Standard Deviation 80.62	—	—	—	—	—	—	—	—
Change in Tissue Stiffness 6 Months	173.03 mmHg/mm Standard Deviation 19.12	166.90 mmHg/mm Standard Deviation 30.79	—	—	—	—	—	—	—	—
Change in Tissue Stiffness 12 Months	170.31 mmHg/mm Standard Deviation 31.14	170.23 mmHg/mm Standard Deviation 30.98	—	—	—	—	—	—	—	—
Change in Tissue Stiffness Baseline	232.89 mmHg/mm Standard Deviation 70.29	16991.96 mmHg/mm Standard Deviation 80448.37	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 3 Months, 6 Months, and 12 Months

Population: Analysis by closure and timepoints

Tissue energy absorption was measured using the BTC2000 to measure the softness of the tissue through the deformation process.

Outcome measures

Measure	FTMB Scar n=23 Participants Subjects assessed the scar treated with FTMB	SOC Scar n=23 Participants Subjects assessed scars closed with standard care closure	FMTB- Week 8 Subjects with FMTB closure	FMTB- Month 3 Subjects with FMTB closure	FMTB- Month 12 Subjects with FMTB closure	Suture- Baseline Subjects with standard of care closure	Sutures- Week 4 Subjects with standard of care closure	Suture- Week 8 Subjects with standard of care closure	Suture Month 3 Subjects with standard of care closure	Suture- Month 12 Subjects with standard of care closure
Change in Tissue Energy Absorption Baseline	66.80 mmHg*mm Standard Deviation 19.42	69.77 mmHg*mm Standard Deviation 22.87	—	—	—	—	—	—	—	—
Change in Tissue Energy Absorption 3 Months	77.17 mmHg*mm Standard Deviation 15.40	81.04 mmHg*mm Standard Deviation 21.15	—	—	—	—	—	—	—	—
Change in Tissue Energy Absorption 6 Months	81.28 mmHg*mm Standard Deviation 10.19	84.57 mmHg*mm Standard Deviation 13.99	—	—	—	—	—	—	—	—
Change in Tissue Energy Absorption 12 Months	85.05 mmHg*mm Standard Deviation 15.08	85.32 mmHg*mm Standard Deviation 13.80	—	—	—	—	—	—	—	—

Adverse Events

FMTB

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Suture

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	FMTB n=36 participants at risk Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA)	Suture n=36 participants at risk SOC: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ)
Skin and subcutaneous tissue disorders Contact Dermititis	2.8% 1/36 • Number of events 1 • 1 year	2.8% 1/36 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Oral Thrush	2.8% 1/36 • Number of events 1 • 1 year	2.8% 1/36 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Cellulitis	2.8% 1/36 • Number of events 1 • 1 year	2.8% 1/36 • Number of events 1 • 1 year

Additional Information

Jennifer Barillas, Research Coordinator

UT Southwestern Department of Plastic Surgery Research

Phone: 214-645-8907

Email: jennifer.bqarillas@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place