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New mesh aims to stop painful breast implant scarring

NCT ID NCT05945329

Disease control Sponsor: C. R. Bard Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a special mesh called GalaFLEX LITE™ in women who need surgery for painful scar tissue (capsular contracture) around breast implants. About 250 women will be randomly assigned to get either the mesh or standard surgery alone. The goal is to see if the mesh helps prevent the scar tissue from returning over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GalaFLEX LITE™ scaffold (a bioabsorbable surgical mesh)
What this could lead to
If it works, this could reduce the chance of painful scar tissue returning after breast implant revision surgery.
What could go wrong
This is an early-stage device trial with no phase designation, so results are uncertain. The mesh may not prevent recurrence better than standard surgery, and risks include infection or implant issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Genetically female ≥22 and ≤70 years of age; 2. Breast augmentation subject with capsular contracture (Baker grade III or IV); 3. Desires a new silicone implant with no more than a ± 150cc volume change in implant size; 4. Planned revision approach via inframammary fold (IMF) incision; 5. Willing and able to comply with the study procedures including the 2-year follow-up visit; 6. Can complete all required study visits as scheduled (i.e., physically attend); 7. Has reviewed and completed an FDA required Breast Implant Patient Decision Checklist (e.g., implant-specific provided by the manufacturer); 8. Has compatible smart technology that can be used for downloading/using the electronic patient diary; and, 9. Provision of signed and dated informed consent form. Exclusion Criteria: 1. BMI \<18 or \>35 2. Existing and/or replacement implant size \> 800 cc 3. Has an extra-capsular silicone breast implant rupture where silicone gel has leaked outside of the capsule) in breast(s) intended for treatment 4. Has prior use of a matrix (synthetic or biologic) in the breast(s) intended for treatment 5. Abnormal breast findings on imaging within 1-year prior to randomization that have not been determined to be benign 6. Subject reported current, or prior history of, Systemic Symptoms Associated with Breast Implants (SSBI - formerly referred to as BII (Breast Implant Illness)) 7. Infection present in the study breast(s) (day of index procedure (surgery) exclusions) 8. Current or recent breastfeeding (within 3-months of enrollment) or history of mastitis within the 6-months prior to enrollment 9. Prior or current diagnosis of breast cancer 10. Has a mass that was palpated and has not been determined benign via acceptable imaging (MRI) or biopsy results 11. Has undergone prior chest radiation treatment 12. Has received chemotherapy within the last 12 months 13. Current or recent (within 1-year of enrollment) alcohol/substance abuse 14. Current or recent (within 4-weeks of enrollment) nicotine user (includes cigarettes, vaping, patches, gum, etc.) 15. History of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIAALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC) 16. Planned use of any other matrix (synthetic, biosynthetic, or biological) in the study breast(s) other than the GalaFLEX LITE™ Scaffold used to fully wrap the implant 17. Planned (within the 2-year follow-up time period) use of medical (e.g. montelukast/Singulair; zafirlukast/Accolate), physical (e.g. massage), or device assisted (e.g. mechanical/thermal ultrasound) tools to manage the breast capsule(s) 18. Any medical condition that, in the opinion of the investigator, may be associated with unduly high risk of intra- or post-operative complications (e.g., insulin dependent diabetes, autoimmune disease, connective tissue disorder, chronic lung or severe cardiovascular disease) 19. Concurrent or planned use (within the 2-year follow-up time period) of autologous fat transfer in the study breast(s) 20. Planned (within the 2-year follow-up time period) elective cosmetic surgery on the study breast(s) (e.g., staged mastopexy; revision for implant size change) 21. Currently enrolled or has plans to enroll in another interventional clinical study that would interfere with this study 22. Is pregnant or plans to become pregnant during the study period 23. Known allergy to tetracycline hydrochloride and/or kanamycin sulfate 24. Any condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes 25. Subject will not remain under the care of the investigator for all breast related plastic surgery procedures while enrolled in the study 26. Actively using immunosuppressants such as oral steroids or biological therapies (inhalers or topical steroids are permitted) 27. Confirmed diagnosis of the following rheumatic diseases or syndromes: systemic lupus erythematosus, Sjorgren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome 28. Has, in the investigator's opinion, a mental illness or disability that would preclude their participation in the study 29. Subject has an implant that was never commercially available in the United States 30. Has been implanted with any silicone implant other than breast implants 31. Is taking any drugs that would interfere with blood clotting or might result in elevated risk of significant postoperative complications (e.g., anticoagulants or antiplatelet medications such as Xarelto, Aspirin, or Eliquis. NSAIDs such as Celebrex, Ibuprofen, Meloxicam are not exclusionary). 32. Works for Sponsor or any of their subsidiaries, the study surgeon, or is helping to conduct the study or are directly related to anyone that works for BD or any of their subsidiaries or the study surgeons 33. Subjects planning to undergo significant weight loss utilizing surgical intervention or prescribed medication(s) (e.g., gastric bypass; gastric sleeve; GLP1 agonists). Subjects with stable weight after previous surgery or current GLP-1 agonists use are not excluded. Day of Index Procedure (Surgery) Exclusion Criteria 1. Has an extra-capsular rupture (breast implant silicone gel has leaked outside of the capsule) in breast(s) intended for treatment 2. Suspicions of cancer from intraoperative capsule appearance such as capsule masses (based on surgical opinion/visual findings; does not require definitive pathology) inclusive of both BIA-ALCL and BIA-SCC; or, 3. Presence of a systemic infection, infection at the surgical site, or infection anywhere in the body at the time of surgery.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Capsular contracture associated with breast implant Capsular contracture grade III Capsular contracture grade IV

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    30 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aesthetic Center for Plastic Surgery

    RECRUITING

    Houston, Texas, 77024, United States

  • Aesthetic Enhancements Plastic Surgery

    RECRUITING

    Orlando, Florida, 32819, United States

  • Allen Gabriel MD

    RECRUITING

    Vancouver, Washington, 98660, United States

  • Athenix Advanced Plastic Surgery & Aesthetic Center

    RECRUITING

    Seattle, Washington, 98005, United States

  • Beauty by Buford

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • Billington Plastic Surgery

    RECRUITING

    St. Petersburg, Florida, 33710, United States

  • California Aesthetic Center

    RECRUITING

    Huntington Beach, California, 92647, United States

  • Careaga Plastic Surgery

    RECRUITING

    Miami, Florida, 33134, United States

  • Charlie Chen MD., Corp

    RECRUITING

    San Diego, California, 92107, United States

  • Defyne MD

    RECRUITING

    Scottsdale, Arizona, 82521, United States

  • Donald S Mowlds, MD A Professional Corporation

    RECRUITING

    Newport Beach, California, 92660, United States

  • Essential Medical Research

    WITHDRAWN

    Tulsa, Oklahoma, 74137, United States

  • Farah Naz Khan

    RECRUITING

    Dallas, Texas, 75219, United States

  • H/K/B Surgery

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Hill Country Plastic Surgery

    RECRUITING

    San Antonio, Texas, 78257, United States

  • Meridian Plastic Surgery Center

    RECRUITING

    Indianapolis, Indiana, 46290, United States

  • Monarch Plastic Surgery and Skin Renewal Center

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Newport Plastic and Reconstructive Surgery Associates

    RECRUITING

    Newport Beach, California, 92660, United States

  • Next Stage Clinical Research

    TERMINATED

    San Antonio, Texas, 78258, United States

  • Northshore Plastic Surgery

    RECRUITING

    Mandeville, Louisiana, 70448, United States

  • Pittsburgh Center for Plastic Surgery

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

    Contact Email: •••••@•••••

  • Plastic Surgery Institute of New York

    RECRUITING

    New York, New York, 10036, United States

  • Reno Tahoe Plastic Surgery

    RECRUITING

    Reno, Nevada, 89511, United States

  • Sanctuary Plastic Surgery

    WITHDRAWN

    Boca Raton, Florida, 33431, United States

  • Southwest Plastic Surgery

    RECRUITING

    El Paso, Texas, 79936, United States

  • Stewart Wang MD Inc.

    RECRUITING

    Pasadena, California, 91101, United States

  • The Graivier Center

    RECRUITING

    Alpharetta, Georgia, 30005, United States

  • The Plastic Surgery Center of Nashville With HKB

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Plastics Clinic

    RECRUITING

    Draper, Utah, 84020, United States

  • The Practice Plastic Surgery

    RECRUITING

    Beverly Hills, California, 90210, United States

  • The Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Tim Sayed MD

    WITHDRAWN

    San Diego, California, 92121, United States

  • VIP Plastic Surgery

    RECRUITING

    West Long Branch, New Jersey, 07764, United States

  • VIVIFY Plastic Surgery

    RECRUITING

    Tampa, Florida, 33606, United States

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