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

Surgical Incision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05028816
• Other study ID #: STU 2021-0791
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: December 1, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Incision
• Surgical Wound

Intervention

Device:
• Side 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.

Other:
• Side 1: Final layer dermal closure with poliglecaprone 25 suture
Current method of wound closure

Device:
• Side 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.

Other:
• Side 2: Final layer dermal closure with poliglecaprone 25 suture
Current method of wound closure

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center- Outpatient Building	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient and Observer Scar Assessment Scale (POSAS)	Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective.	8 Weeks, 3 Months, 6 Months and 12 Months
Primary	Photographic Assessment	Photographs will be utilized for evaluation of he appearance of surgical scars.	Baseline, 2 Week, 4 Week, 6 Week, 8 Week, 3 Months, 6 Months and 12 Months
Secondary	Scar Volume/Surface Area	eKare will be used to asses scar volume and surface area.	Baseline, 4 Week, 8 Week, 3 Months, 6 Months, and 12 Months
Secondary	Gene Regulation	Biopsy will be obtained to assess gene expression.	Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Secondary	Gene Analysis	Biopsy will be obtained to assess gene expression.	Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Secondary	Collagen volume/ appearance on pathology	Biopsy will be obtained to assess collagen volume/appearance.	Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Secondary	Colorimetry	Tool will utilize realistic human skin tones to assess the coloring of patients scars	Baseline, 2 Weeks, 4 Weeks, 6 Weeks, 8 Weeks, 3 Months, 6 Months and 12 Months
Secondary	Length of adherence	The bridge shields will be assessed at each visit	Baseline, 2 Weeks, 4 Weeks, 6 Weeks, 8 Weeks, 3 Months, 6 Months and 12 Months
Secondary	Non-Invasive skin measurements	Skin measurements (ultrasonography, optical coherence topography, transepidermal water loss, laxity, stiffness, energy absorption, elasticity and deformation values.	Baseline, 4 Week, 8 Week, 3 Months, 6 Months, and 12 Months