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A Study for Women Having Revision Breast Implant Surgery

Prevention

An interventional study for women undergoing revision breast implant surgery

Clinicaltrials.gov identifier:
NCT05945329

Study Contact Information:

Primary Contact:
Niccole Diaz
Phone: 407-694-0553
Email: Niccole.Diaz@bd.com

Backup Contact:
Jenna Baccari
Email: jenna.baccari@bd.com

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Overview
Who Can Join
Details
Contact
Locations
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About the Study

This study is evaluating whether a surgical support mesh called GalaFLEX LITE™ Scaffold can improve outcomes for women undergoing breast implant surgery due to complications such as capsular contracture (hardening of scar tissue around the implant).

The goal is to determine if the mesh helps:

  • Keep the implant in place
  • Reduce the risk of capsular contracture returning
  • Improve overall surgical outcomes

Researchers will also study:

  • Patient satisfaction and quality of life
  • Short-term safety (such as infection or fluid buildup)
  • Longer-term complications, including:
    • Implant loss
    • Wound healing problems
    • Need for additional surgeries
    • Recurrence of capsular contracture

This Study is Open To:

This study is open to women ages 22–66 who:

  • Have breast implants and moderate to severe capsular contracture
  • Are planning a breast implant surgery
  • Plan to replace the implant with a similar size
  • Plan to have surgery through the crease under the breast
  • Live within about 3 hours of a study site
  • Are willing to attend follow-up visits for up to 2 years

This Study is NOT Open To:

You may not be eligible if you:

  • Have a BMI below 18 or above 35
  • Have implants not approved in the U.S.
  • Have a ruptured or leaking implant
  • Have had 2 or more prior surgeries for capsular contracture
  • Previously had mesh or similar material placed in the breast
  • Plan to use another type of surgical mesh or matrix
  • Plan additional breast surgeries within the next 2 years
  • Have a history of breast cancer or current signs of breast cancer
  • Have had radiation to the chest
  • Had chemotherapy within the past year
  • Have a history of implant-related cancers
  • Have autoimmune or connective tissue diseases
  • Have serious medical conditions that increase surgical risk
  • Take medications that suppress the immune system
  • Take blood-thinning medications
  • Are currently pregnant, breastfeeding, or have recently given birth
  • Plan to become pregnant within the next 2 years
  • Had breast infection (mastitis) in the past 6 months
  • Currently use nicotine products
  • Have had alcohol or substance abuse within the past year
  • Plan to use other treatments to manage scar tissue (such as massage therapy)

What the Study Involves

Participants are randomly assigned to one of two groups:

  • Group 1: surgery using the GalaFLEX LITE™ Scaffold (support mesh)
  • Group 2: Standard surgery without the mesh

Participants will not be told which group they are in until the study is completed.

All participants will:

  • Have breast implant surgery
  • Complete follow-up visits for up to 2 years
  • Fill out surveys about quality of life, comfort, and satisfaction (at about 12 and 24 months)

Study Contact Information:

Primary Contact:
Niccole Diaz
Phone: 407-694-0553
Email: Niccole.Diaz@bd.com

Backup Contact:
Jenna Baccari
Email: jenna.baccari@bd.com

Locations:

Arizona

City: Scottsdale RECRUITING
Facility: Defyne MD
Contact Info:
manager@defynemd.com 480-561-6185
Oren Tessler

California

City: Beverly Hills RECRUITING
Facility: The Practice Plastic Surgery
Contact Info:
star@thepracticeps.com 310-278-8200
Kelly Killeen, MD, FACS

City: Huntington Beach RECRUITING
Facility: California Aesthetic Center
Contact Info:
tracy@stevevumd.com 714-848-1133
Steve Vu

City: Newport Beach RECRUITING
Facility: Donald S Mowlds, MD A Professional Corporation
Contact Info:
mallory@donaldmowldsmd.com 949-759-5539
Donald S Mowlds, MD

City: Newport Beach RECRUITING
Facility: Newport Plastic and Reconstructive Surgery Associates
Contact Info:
loulya@newportplastic.com 949-251-1502
Hisham Seify

City: Pasadena RECRUITING
Facility: Stewart Wang MD Inc.
Contact Info:
dulce@wangplasticsurgery.com 626-796-6680
Stewart Wang

City: San Diego RECRUITING
Facility: Charlie Chen MD., Corp
Contact Info:
baysmallwood@me.com 858-255-1538
Charlie Chen

Colorado

City: Lone Tree RECRUITING
Facility: Beauty by Buford
Contact Info:
courtney@kerloresearch.com 720-924-9296
Gregory Buford

Florida

City: Miami RECRUITING
Facility: Careaga Plastic Surgery
Contact Info:
bgarcia@absolutemedicalcenter.com 305-574-9262
Daniel Careaga, MD

City: Orlando RECRUITING
Facility: Aesthetic Enhancements Plastic Surgery
Contact Info:
ashley@drarmandosoto.com 407-218-4550
Armando Soto

City: St. Petersburg RECRUITING
Facility: Billington Plastic Surgery
Contact Info:
nicole@billingtonmd.com 727-341-0337
Alicia Billington, MD

City: Tampa RECRUITING
Facility: VIVIFY Plastic Surgery
Contact Info:
Marlie@vivifyps.com 386-986-7010
Dallas Buchanan, MD

Georgia

City: Alpharetta RECRUITING
Facility: The Graivier Center
Contact Info:
a.miller@thegraiviercenter.com 770-772-0695
David Hill, MD

City: Atlanta RECRUITING
Facility: Monarch Plastic Surgery and Skin Renewal Center
Contact Info:
ashlee@monarchga.com 404-250-3333
Carmen Kavali

Indiana

City: Indianapolis RECRUITING
Facility: Meridian Plastic Surgery Center
Contact Info:
lyoung@meridianplastic.com 317-575-0330
Bruce W Van Natta

Louisiana

City: Mandeville RECRUITING
Facility: Northshore Plastic Surgery
Contact Info:
erin@drboudreaux.com 985-237-6050
Jeffrey Claiborne

Missouri

City: St Louis RECRUITING
Facility: The Washington University
Contact Info:
aliyaht@wustl.edu 314-362-2641
Justin Sacks

North Carolina

City: Huntersville RECRUITING
Facility: H/K/B Surgery
Contact Info:
erin.l@hkbsurgery.com 704-659-2529
Bill Kortesis, MD, FACS

New Jersey

City: West Long Branch RECRUITING
Facility: VIP Plastic Surgery
Contact Info:
paige@doctorvnj.com 732-963-0809
Rahul Vemula

Nevada

City: Reno RECRUITING
Facility: Reno Tahoe Plastic Surgery
Contact Info:
erika@drmccormack.com 775-284-2020
Tiffany McCormack, MD

New York

City: New York RECRUITING
Facility: Plastic Surgery Institute of New York
Contact Info:
DrDelMauro@BodySculptingCenterNYC.com 646-257-2677
Matthew DelMauro, MD
Adam Schaffner, MD

Pennsylvania

City: Pittsburgh RECRUITING
Facility: Pittsburgh Center for Plastic Surgery
Contact Info:
research@pghplasticsurgery.com 412-802-6100
David Turer, MD

Tennessee

City: Nashville RECRUITING
Facility: The Plastic Surgery Center of Nashville With HKB
Contact Info:
latasha@nashvillesurgery.com 615-467-6777
kayla@nashvillesurgery.com
Mary Gingrass, MD
Melinda Haws

Texas

City: Dallas RECRUITING
Facility: Farah Naz Khan
Contact Info:
matt@khanplasticsurgery.com 469-437-5426
Farah Khan

City: El Paso RECRUITING
Facility: Southwest Plastic Surgery
Contact Info:
michael@swplasticsurgery.com
Frank Agullo

City: Houston RECRUITING
Facility: Aesthetic Center for Plastic Surgery
Contact Info:
kzihlman@kalonaesthetics.com
Kristi Hustak

City: San Antonio RECRUITING
Facility: Hill Country Plastic Surgery
Contact Info:
Sylvia.Trujillo@hillcountryps.com 210-658-3555
Amita Shah
Scott Farber

Utah

City: Draper RECRUITING
Facility: The Plastics Clinic
Contact Info:
kincaid@theplasticsclinic.com 801-839-5557
Jerry Chidester

Washington

City: Seattle RECRUITING
Facility: Athenix Advanced Plastic Surgery & Aesthetic Center
Contact Info:
drdry@athenixbody.com 425-307-3546
Gavin Dry

City: Vancouver RECRUITING
Facility: Allen Gabriel MD
Contact Info:
manroop@allengabrielmd.com
Allen Gabriel

Prevention

An interventional study for women undergoing revision breast implant surgery

Clinicaltrials.gov identifier:
NCT05945329

Study Contact Information:

Primary Contact:
Niccole Diaz
Phone: 407-694-0553
Email: Niccole.Diaz@bd.com

Backup Contact:
Jenna Baccari
Email: jenna.baccari@bd.com

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