Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation (STANCE)

May 21, 2026 updated by: C. R. Bard

A Prospective, Randomized, Controlled, Multi-Center Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation

Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast augmentation patients versus patients undergoing conventional revision surgery with no supportive matrix or acellular dermal matrix (ADM). Subjects will be randomized 2:1 to receive either GalaFLEX LITE™ Scaffold or standard care (no ADM or matrix placement). This study is designed using an adaptive approach. The number of the treated breasts will range between 250 and 530.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Capsular contracture is the number one complication leading to revision surgery after breast augmentation(2-4) which has been commonly cited as impacting 10 to 20% of all breast augmentation patients.(5-10) A prospective, randomized controlled study of patients presenting with Baker grade III or IV capsular contracture will be undertaken to investigate the ability of P4HB (specifically GalaFLEX LITE™ Scaffold) to reduce the recurrence of clinically significant CC and/or malposition requiring surgical correction. The primary endpoint is a composite of capsular contracture recurrence and/or breast implant malposition recommended for surgery OR breast infections requiring oral or IV antibiotic treatment within 90 days of surgery and/or peri-implant fluid collection needing a drainage procedure within 10-90 days of surgery.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 82521
        • Recruiting
        • Defyne MD
        • Contact:
        • Principal Investigator:
          • Oren Tessler
    • California
      • Beverly Hills, California, United States, 90210
        • Recruiting
        • The Practice Plastic Surgery
        • Principal Investigator:
          • Kelly Killeen, MD, FACS
        • Contact:
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • California Aesthetic Center
        • Contact:
        • Principal Investigator:
          • Steve Vu
      • Newport Beach, California, United States, 92660
        • Recruiting
        • Newport Plastic and Reconstructive Surgery Associates
        • Contact:
        • Principal Investigator:
          • Hisham Seify
      • Newport Beach, California, United States, 92660
        • Recruiting
        • Donald S Mowlds, MD A Professional Corporation
        • Contact:
        • Principal Investigator:
          • Donald S Mowlds, MD
      • Pasadena, California, United States, 91101
        • Recruiting
        • Stewart Wang MD Inc.
        • Contact:
        • Principal Investigator:
          • Stewart Wang
      • San Diego, California, United States, 92121
        • Withdrawn
        • Tim Sayed MD
      • San Diego, California, United States, 92107
        • Recruiting
        • Charlie Chen MD., Corp
        • Contact:
        • Principal Investigator:
          • Charlie Chen
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Beauty by Buford
        • Contact:
        • Principal Investigator:
          • Gregory Buford
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Withdrawn
        • Sanctuary Plastic Surgery
      • Miami, Florida, United States, 33134
        • Recruiting
        • Careaga Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Daniel Careaga, MD
      • Orlando, Florida, United States, 32819
        • Recruiting
        • Aesthetic Enhancements Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Armando Soto
      • St. Petersburg, Florida, United States, 33710
        • Recruiting
        • Billington Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Alicia Billington, MD
      • Tampa, Florida, United States, 33606
        • Recruiting
        • VIVIFY Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Dallas Buchanan, MD
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Recruiting
        • The Graivier Center
        • Contact:
        • Principal Investigator:
          • David Hill, MD
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • Monarch Plastic Surgery and Skin Renewal Center
        • Contact:
        • Principal Investigator:
          • Carmen Kavali
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Recruiting
        • Meridian Plastic Surgery Center
        • Contact:
        • Principal Investigator:
          • Bruce W Van Natta
    • Louisiana
      • Mandeville, Louisiana, United States, 70448
        • Recruiting
        • Northshore Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Jeffrey Claiborne
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • The Washington University
        • Contact:
        • Principal Investigator:
          • Justin Sacks
    • Nevada
      • Reno, Nevada, United States, 89511
        • Recruiting
        • Reno Tahoe Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Tiffany McCormack, MD
    • New Jersey
      • West Long Branch, New Jersey, United States, 07764
        • Recruiting
        • VIP Plastic Surgery
        • Principal Investigator:
          • Rahul Vemula
        • Contact:
    • New York
      • New York, New York, United States, 10036
        • Recruiting
        • Plastic Surgery Institute of New York
        • Contact:
        • Principal Investigator:
          • Matthew DelMauro, MD
        • Sub-Investigator:
          • Adam Schaffner, MD
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • H/K/B Surgery
        • Contact:
        • Principal Investigator:
          • Bill Kortesis, MD, FACS
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Withdrawn
        • Essential Medical Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Pittsburgh Center for Plastic Surgery
        • Contact:
        • Principal Investigator:
          • David Turer, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • The Plastic Surgery Center of Nashville With HKB
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mary Gingrass, MD
        • Sub-Investigator:
          • Melinda Haws
    • Texas
      • Dallas, Texas, United States, 75219
        • Recruiting
        • Farah Naz Khan
        • Contact:
        • Principal Investigator:
          • Farah Khan
      • El Paso, Texas, United States, 79936
      • Houston, Texas, United States, 77024
        • Recruiting
        • Aesthetic Center for Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Kristi Hustak
      • San Antonio, Texas, United States, 78257
        • Recruiting
        • Hill Country Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Amita Shah
        • Sub-Investigator:
          • Scott Farber
      • San Antonio, Texas, United States, 78258
        • Terminated
        • Next Stage Clinical Research
    • Utah
      • Draper, Utah, United States, 84020
        • Recruiting
        • The Plastics Clinic
        • Contact:
        • Principal Investigator:
          • Jerry Chidester
    • Washington
      • Seattle, Washington, United States, 98005
        • Recruiting
        • Athenix Advanced Plastic Surgery & Aesthetic Center
        • Contact:
        • Principal Investigator:
          • Gavin Dry
      • Vancouver, Washington, United States, 98660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GalaFlex Light Scaffold
Surgery performed with GalaFlex Lite Scaffold.
Device: GalaFLEX LITE™ Scaffold
Bioabsorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB) and knitted into a surgical scaffold used to reinforce soft tissue
Active Comparator: Standard Surgery
Surgery performed using standard surgical procedures with no scaffold.
Other: Standard surgery
Surgery performed without the use of a scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket
Time Frame: 24-months after index surgery
Composite of Recurrent Capsular Contracture Baker grade III/IV and/or breast implant malposition
24-months after index surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient quality of life and satisfaction (12-month)
Time Frame: 12-months after index surgery
Select Breast-Q© modules (standardized patient survey) for the treated breast(s): psychosocial wellbeing; sexual wellbeing; satisfaction with breasts; and physical wellbeing - chest
12-months after index surgery
Patient quality of life and satisfaction
Time Frame: 24-months after index surgery
Select Breast-Q© modules (standardized patient survey) for the treated breast(s): psychosocial wellbeing; sexual wellbeing; satisfaction with breasts; and physical wellbeing - chest
24-months after index surgery
Safety of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket, reduction of capsular contracture recurrence, and/or malposition
Time Frame: 90 days

The occurrence of:

  • Breast fluid collection requiring a drainage procedure at any time, or after drain removal if one is used, within 90 days of surgery
  • Breast infection requiring oral (PO) or intravenous (IV) antibiotics related to the contracture revision surgery within 90 days of surgery
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device or procedure related adverse events
Time Frame: 24-months after index surgery
Select adverse events including: breast infection requiring PO or IV antibiotics related to the revision surgery; breast fluid collection requiring a drainage procedure; breast implant loss; any unscheduled/unanticipated breast reoperation; breast implant malposition recommended for surgery; skin necrosis; wound dehiscence; any seroma within 90 days of surgery; any hematoma within 90 days of surgery; capsular contracture Baker Grade >1; and red breast syndrome
24-months after index surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. R. Bard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DVL-BR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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