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

The University of Texas System (UT)

Status: Completed

Conditions: Surgical Incision

Treatments: Device: Side 2: Final layer closure with force modulating tissue bridges (FMTB); Other: Side 1: Final layer dermal closure with poliglecaprone 25 suture; Device: Side 1: Final layer closure with force modulating tissue bridges (FMTB); Other: Side 2: Final layer dermal closure with poliglecaprone 25 suture

Study type: Interventional

Funder types: Other

Identifiers

NCT05028816

STU 2021-0791

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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39 participants in 2 patient groups

Group 1

Other group

Description:

Side 1: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ) Side 2: Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA)

Treatment:

Other: Side 1: Final layer dermal closure with poliglecaprone 25 suture

Device: Side 2: Final layer closure with force modulating tissue bridges (FMTB)

Group 2

Other group

Description:

Side 1: Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA) Side 2: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ)

Treatment:

Other: Side 2: Final layer dermal closure with poliglecaprone 25 suture

Device: Side 1: Final layer closure with force modulating tissue bridges (FMTB)