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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

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

Study Summary

This trial will follow 42 women who are getting breast reduction surgery. It is a prospective, single blinded study, which means that the study will happen going forward and that only some people will know which treatment the women are getting.

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.Check my eligibility

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.See study design

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.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient and Observer Scar Assessment Scale (POSAS)

Photographic Assessment

Secondary outcome measures

Collagen volume/ appearance on pathology

Colorimetry

Gene Analysis

+4 more

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 / 2Eligibility criteria met

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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,757 Total Patients Enrolled

Jeffrey Kenkel, MDPrincipal InvestigatorChairman, UT Southwestern

12 Previous Clinical Trials

221 Total Patients Enrolled

Media Library

Group 1 Clinical Trial Eligibility Overview. Trial Name: NCT05028816 — N/A

Surgical Incisions Research Study Groups: Group 1, Group 2

Surgical Incisions Clinical Trial 2023: Group 1 Highlights & Side Effects. Trial Name: NCT05028816 — N/A

Group 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT05028816 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still an option for this research project?

"Per the details on clinicaltrials.gov, this research is no longer actively recruiting participants; it was first listed in October 5th of 2021 and lastly modified on January 27th 2022. Although this trial has ceased to accept new enrollees, 85 other studies are presently seeking patients."

Answered by AI

What goals is this trial hoping to achieve?

"Primarily, this clinical trial will measure the effectiveness of a treatment through Patient and Observer Scar Assessment Scale (POSAS). Subsequently, eKare will be used to determine scar volume/surface area. Additionally, bridge shields are analyzed at each visit for length adherence; finally, colourimetry is employed using realistic human skin tones to assess the hue of patients' scars over Baseline, 2 Week, 4 Week, 6 Week, 8 Week 3 Months ,6 Months and 12 Months intervals."

Answered by AI

What are the eligibility criteria for participating in this trial?

"To qualify for this study, post-surgical patients must be between 18 and 65 years of age. Currently, our team is hoping to recruit approximately 42 individuals who meet these criteria."

Answered by AI