N/A
N=36
Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
Surgical Incision
Bottom Line
View on ClinicalTrials.gov: NCT05028816 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M — 1.09; 1.22; 1.3; 1.87 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Side 1: Final layer closure with force modulating tissue bridges (FMTB) (Device); Side 1: Final layer dermal closure with poliglecaprone 25 suture (Other); Side 2: Final layer closure with force modulating tissue bridges (FMTB) (Device); Side 2: Final layer dermal closure with poliglecaprone 25 suture (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M |
1.09; 1.22; 1.3; 1.87; 4.22; 1.22 | — |
| PRIMARY Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M |
1.05; 1.00; 1.11; 1.22; 4.37; 4.53 | — |
| PRIMARY Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M |
1.30; 1.30; 2.40; 2.15; 4.55; 4.60 | — |
| PRIMARY Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M |
1.45; 1.70; 1.75; 2.20; 1.55; 1.90 | — |
| PRIMARY Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M |
1.26; 1.30; 1.74; 2.04; 1.70; 1.96 | — |
| PRIMARY Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M |
1.47; 1.53; 1.68; 2.37; 1.32; 1.63 | — |
| SECONDARY Scar Area Assessment |
1.53; 2.16; 1.61; 2.28; 1.69; 2.65 | — |
| SECONDARY Gene Regulation- Elastin |
1.09; 0.80; 1.04; 0.82; 1.21; 0.92 | — |
| SECONDARY Gene Analysis- Macrophage |
1.00; 0.77; 0.99; 0.98; 0.50; 1.000 | — |
| SECONDARY Histology Collagen 3 |
1.11; 1.19; 1.13; 1.37; 1.46; 0.89 | — |
| SECONDARY Change in Mechanical Properties of Human Tissue |
149.70; 149.70; 149.58; 149.62; 149.78; 149.70 | — |
| SECONDARY Histology Collagen 1 |
1.00; 1.02; 0.92; 1.17; 0.92; 1.00 | — |
| SECONDARY Scar Maximum Depth |
0.07; 0.09; 0.09; 0.10; 0.07; 0.09 | — |
| SECONDARY Interleukin-8 (IL8) |
1.39; 30.49; 14.75; 9.38; 0.18; 1.09 | — |
| SECONDARY Interleukin-6 (IL6) |
1.25; 2.89; 2.23; 7.96; 0.53; 5.89 | — |
| SECONDARY Measure of the Skins Function |
10.01; 10.45; 10.53; 9.64; 9.97; 9.78 | — |
| SECONDARY Change in Tissue Density |
81.53; 55.08; 82.67; 53.53; 83.37; 28.92 | — |
| SECONDARY Change in Tissue Thickness |
102.43; 1020.87; 102.91; 977.61; 92.42; 1073.79 | — |
| SECONDARY Change in Tissue Stiffness |
232.89; 16991.96; 179.50; 185.53; 173.03; 166.90 | — |
| SECONDARY Change in Tissue Energy Absorption |
66.80; 69.77; 77.17; 81.04; 81.28; 84.57 | — |
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
Eligibility Criteria
Inclusion Criteria
- Healthy adult females 18-65 years of age
- Planned procedure is bilateral breast reduction with modified Wise (anchor, inverted "T") scar pattern.
- Ability to adhere wound therapy after surgery for 8 weeks or have a willing family member/partner to assist with wound therapy care.
- Willing to follow wound care therapy as instructed by study staff.
- Willing to return for follow up visits and undergo study evaluations.
Exclusion Criteria
- Individuals diagnosed with known allergy to general adhesives/adhesive tape
- Individuals with a history of using the following prescription medications:
- Accutane within the past year;
- Systemic steroid use within the past year
- 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
Data sourced from ClinicalTrials.gov (NCT05028816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.