Clinical trial NCT05028816: Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
Official title: Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Incision
Keywords: Wound Healing
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomization will occur after all the portions of the surgical procedure are completed except for final skin layer closure.
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 8 Weeks, 3 Months, 6 Months and 12 Months
measure: Photographic Assessment
timeFrame: Baseline, 2 Week, 4 Week, 6 Week, 8 Week, 3 Months, 6 Months and 12 Months
Secondary outcomes:
measure: Scar Volume/Surface Area
timeFrame: Baseline, 4 Week, 8 Week, 3 Months, 6 Months, and 12 Months
measure: Gene Regulation
timeFrame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
measure: Gene Analysis
timeFrame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
measure: Collagen volume/ appearance on pathology
timeFrame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
measure: Colorimetry
timeFrame: Baseline, 2 Weeks, 4 Weeks, 6 Weeks, 8 Weeks, 3 Months, 6 Months and 12 Months
measure: Length of adherence
timeFrame: Baseline, 2 Weeks, 4 Weeks, 6 Weeks, 8 Weeks, 3 Months, 6 Months and 12 Months
measure: Non-Invasive skin measurements
timeFrame: Baseline, 4 Week, 8 Week, 3 Months, 6 Months, and 12 Months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center- Outpatient Building
state: Texas
Study officials:
affiliation: Chairman, UT Southwestern
name: Jeffrey Kenkel, MD
role: PRINCIPAL_INVESTIGATOR
References: