Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
CompletedNAResults postedLast updated 2 July 2025
What this trial tests
NA trial testing Side 1: Final layer closure with force modulating tissue bridges (FMTB) in Surgical Incision in 39 participants. Completed in 1 December 2024.
Timeline
5 October 2021
Primary endpoint 4 April 2024
1 December 2024
Quick facts
Lead sponsor
University of Texas Southwestern Medical Center
Phase
NA
Status
Completed
Study type
INTERVENTIONAL
Allocation
randomized
Design
crossover
Masking
quadruple
Primary purpose
supportive care
Enrollment
39
Start date
5 October 2021
Primary completion
4 April 2024
Estimated completion
1 December 2024
Sites
1 location across United States
Drugs / interventions tested
Side 1: Final layer closure with force modulating tissue bridges (FMTB)
Side 1: Final layer dermal closure with poliglecaprone 25 suture
Side 2: Final layer closure with force modulating tissue bridges (FMTB)
Side 2: Final layer dermal closure with poliglecaprone 25 suture
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 ou
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 ou
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 ou
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 ou
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 ou
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 ou
Vascularity
Group
Value
95% CI
FTMB Scar
1.47
± 0.77
SOC Scar
1.53
± 0.77
Pigmentation
Group
Value
95% CI
FTMB Scar
1.68
± 0.82
SOC Scar
2.37
± 0.96
Thickness
Group
Value
95% CI
FTMB Scar
1.32
± 0.48
SOC Scar
1.63
± 0.68
Relief
Group
Value
95% CI
FTMB Scar
1.16
± 0.69
SOC Scar
1.32
± 0.58
Pliability
Group
Value
95% CI
FTMB Scar
1.16
± 0.69
SOC Scar
1.11
± 0.46
Surface Area
Group
Value
95% CI
FTMB Scar
1.16
± 0.37
SOC Scar
1.26
± 0.56
Scar Area AssessmentSecondary· 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.
Biopsy will be obtained to assess early wound healing and ECM formation during scaffold integration Fold change= sample/average of the baseline
Group
Value
95% CI
FMTB- Baseline
1.11
± 0.21
FMTB- Week 4
1.19
± 0.22
FMTB- Week 8
1.13
± 0.22
FMTB- Month 3
1.37
± 1.46
FMTB- Month 12
1.46
± 0.11
Suture- Baseline
0.89
± 0.14
Sutures- Week 4
0.89
± 0.18
Suture- Week 8
1.38
± 0.22
Suture Month 3
1.13
± 0.31
Suture- Month 12
1.51
± 0.19
Change in Mechanical Properties of Human TissueSecondary· 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.
Biopsy will be obtained to assess collagen synthesis, restoring dermal strength and elasticity during regeneration fold change= sample/average of the baseline
Group
Value
95% CI
FMTB- Baseline
1.00
± 0.25
FMTB- Week 4
1.02
± 0.13
FMTB- Week 8
0.92
± 0.16
FMTB- Month 3
1.17
± 0.20
FMTB- Month 12
0.92
± 0.15
Suture- Baseline
1.00
± 0.16
Sutures- Week 4
0.91
± 0.12
Suture- Week 8
0.97
± 0.17
Suture Month 3
1.18
± 0.25
Suture- Month 12
1.04
± 0.07
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 2 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05028816.