What is the mechanism of action of this treatment?

The most common treatments for surgical incisions, particularly in the context of the Inverted Wise Incision Pattern used in breast reduction surgery, focus on minimizing infection, promoting healing, and enhancing cosmetic outcomes. This surgical technique involves creating an anchor-shaped incision to remove excess tissue and skin, followed by precise suturing to reshape the breast. Key treatments include meticulous surgical techniques to reduce tissue trauma, prophylactic antibiotics to prevent infection, and advanced wound closure methods like force-modulating tissue bridges to minimize tension on the incision site. These treatments are essential for reducing complications, improving healing times, and achieving better aesthetic results for patients.

What side effects are associated with this type of intervention?

Common side effects of surgical incisions, including those similar to the Inverted Wise Incision Pattern used in breast reduction, include scarring, infection, bleeding, and hematoma formation. Techniques like the zigzag wavy-line periareolar incision aim to minimize visible scarring. Laser treatments, which are sometimes used to improve cosmetic outcomes, can also result in side effects such as necrosis.

What prior FDA approvals exist?

FDA-approved treatments for surgical incisions, including those similar to the Inverted Wise Incision Pattern used in breast reduction surgery, typically focus on wound care and scar management. Commonly approved treatments include silicone gel sheets and ointments, which are used to reduce scarring, and antimicrobial dressings to prevent infection. Additionally, certain advanced wound care products like hydrocolloid and foam dressings are also approved to promote optimal healing environments. While specific drugs for the Inverted Wise Incision Pattern are not detailed, these general treatments are widely applicable to various surgical incisions.

What other types of research exist?

Promising, novel alternatives to the Inverted Wise Incision Pattern for breast reduction surgery include the batwing mastopexy and central breast resection. The batwing mastopexy allows for the resection of cancers adjacent to or deep to the nipple-areola complex (NAC) without sacrificing the nipple, preserving NAC viability and the breast mound. Central breast resection is suitable for centrally located cancers with NAC involvement, allowing for breast-conserving surgery that includes removal of the NAC and cancer with negative margins, potentially preserving the forward projection of the breast.

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Force Modulating Tissue Bridges for Surgical Wound Closure

N/A

Waitlist Available

Led By Jeffrey Kenkel, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy adult females 18-65 years of age

Planned procedure is bilateral breast reduction with modified Wise (anchor, inverted 'T') scar pattern

Must not have

Individuals with significant scarring on the test site/area(s)

Individuals with a history of systemic steroid use within the past year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 week, 4 week, 6 week, 8 week, 3 months, 6 months and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special bandage for women aged 18-65 having breast reduction surgery. The bandage helps close and support the surgical wound and is reapplied regularly. The goal is to see if it helps the wound heal better and reduces scarring compared to traditional stitches.

Who is the study for?

This trial is for healthy adult women aged 18-65 planning to undergo elective breast reduction surgery with a specific scar pattern. Participants must be able to manage wound care post-surgery or have someone to assist, and commit to follow-up visits. Excluded are those with malnutrition, BMI >35, history of radiation therapy or certain medication use within the past year, known allergies to adhesives, active smokers, and conditions affecting wound healing.

What is being tested?

The study compares two methods of closing surgical wounds in breast reduction: one side using standard sutures (poliglecaprone 25) and the other using force modulating tissue bridges (FMTB). Each participant will have both techniques applied on different sides of their body randomly. The effectiveness of each method in healing scars will be evaluated.

What are the potential side effects?

Potential side effects may include reactions at the suture site such as redness, swelling, pain or discomfort. There's also a risk of infection at the wound site or an allergic reaction if sensitivity to materials used exists.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a healthy woman aged between 18 and 65.

Select...

I am scheduled for a breast reduction surgery with an anchor scar.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have significant scarring in the area to be tested.

Select...

I have used steroids in the past year.

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I have not used Accutane in the last year.

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My BMI is over 35.

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I have had radiation therapy in the past.

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I have a history of breast cancer.

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I do not have a condition that affects my body's ability to heal wounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 week, 4 week, 6 week, 8 week, 3 months, 6 months and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 week, 4 week, 6 week, 8 week, 3 months, 6 months and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 week, 4 week, 6 week, 8 week, 3 months, 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient and Observer Scar Assessment Scale (POSAS)

Photographic Assessment

Secondary study objectives

Collagen volume/ appearance on pathology

Colorimetry

Gene Analysis

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment2 Interventions

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)

Group II: Group 1Experimental Treatment2 Interventions

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)

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for surgical incisions, particularly in the context of the Inverted Wise Incision Pattern used in breast reduction surgery, focus on minimizing infection, promoting healing, and enhancing cosmetic outcomes. This surgical technique involves creating an anchor-shaped incision to remove excess tissue and skin, followed by precise suturing to reshape the breast. Key treatments include meticulous surgical techniques to reduce tissue trauma, prophylactic antibiotics to prevent infection, and advanced wound closure methods like force-modulating tissue bridges to minimize tension on the incision site. These treatments are essential for reducing complications, improving healing times, and achieving better aesthetic results for patients.

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