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: [email protected]
Backup Contact:
Jenna Baccari
Email: [email protected]
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: [email protected]
Backup Contact:
Jenna Baccari
Email: [email protected]
Locations:
Arizona
City: Scottsdale RECRUITING
Facility: Defyne MD
Contact Info:
[email protected]
480-561-6185
Oren Tessler
California
City: Beverly Hills RECRUITING
Facility: The Practice Plastic Surgery
Contact Info:
[email protected]
310-278-8200
Kelly Killeen, MD, FACS
City: Huntington Beach RECRUITING
Facility: California Aesthetic Center
Contact Info:
[email protected]
714-848-1133
Steve Vu
City: Newport Beach RECRUITING
Facility: Donald S Mowlds, MD A Professional Corporation
Contact Info:
[email protected]
949-759-5539
Donald S Mowlds, MD
City: Newport Beach RECRUITING
Facility: Newport Plastic and Reconstructive Surgery Associates
Contact Info:
[email protected]
949-251-1502
Hisham Seify
City: Pasadena RECRUITING
Facility: Stewart Wang MD Inc.
Contact Info:
[email protected]
626-796-6680
Stewart Wang
City: San Diego RECRUITING
Facility: Charlie Chen MD., Corp
Contact Info:
[email protected]
858-255-1538
Charlie Chen
Colorado
City: Lone Tree RECRUITING
Facility: Beauty by Buford
Contact Info:
[email protected]
720-924-9296
Gregory Buford
Florida
City: Miami RECRUITING
Facility: Careaga Plastic Surgery
Contact Info:
[email protected]
305-574-9262
Daniel Careaga, MD
City: Orlando RECRUITING
Facility: Aesthetic Enhancements Plastic Surgery
Contact Info:
[email protected]
407-218-4550
Armando Soto
City: St. Petersburg RECRUITING
Facility: Billington Plastic Surgery
Contact Info:
[email protected]
727-341-0337
Alicia Billington, MD
City: Tampa RECRUITING
Facility: VIVIFY Plastic Surgery
Contact Info:
[email protected]
386-986-7010
Dallas Buchanan, MD
Georgia
City: Alpharetta RECRUITING
Facility: The Graivier Center
Contact Info:
[email protected]
770-772-0695
David Hill, MD
City: Atlanta RECRUITING
Facility: Monarch Plastic Surgery and Skin Renewal Center
Contact Info:
[email protected]
404-250-3333
Carmen Kavali
Indiana
City: Indianapolis RECRUITING
Facility: Meridian Plastic Surgery Center
Contact Info:
[email protected]
317-575-0330
Bruce W Van Natta
North Carolina
City: Huntersville RECRUITING
Facility: H/K/B Surgery
Contact Info:
[email protected]
704-659-2529
Bill Kortesis, MD, FACS
New Jersey
City: West Long Branch RECRUITING
Facility: VIP Plastic Surgery
Contact Info:
[email protected]
732-963-0809
Rahul Vemula
Nevada
City: Reno RECRUITING
Facility: Reno Tahoe Plastic Surgery
Contact Info:
[email protected]
775-284-2020
Tiffany McCormack, MD
New York
City: New York RECRUITING
Facility: Plastic Surgery Institute of New York
Contact Info:
[email protected]
646-257-2677
Matthew DelMauro, MD
Adam Schaffner, MD
Pennsylvania
City: Pittsburgh RECRUITING
Facility: Pittsburgh Center for Plastic Surgery
Contact Info:
[email protected]
412-802-6100
David Turer, MD
Tennessee
City: Nashville RECRUITING
Facility: The Plastic Surgery Center of Nashville With HKB
Contact Info:
[email protected]
615-467-6777
[email protected]
Mary Gingrass, MD
Melinda Haws
Texas
City: Dallas RECRUITING
Facility: Farah Naz Khan
Contact Info:
[email protected]
469-437-5426
Farah Khan
City: El Paso RECRUITING
Facility: Southwest Plastic Surgery
Contact Info:
[email protected]
Frank Agullo
City: Houston RECRUITING
Facility: Aesthetic Center for Plastic Surgery
Contact Info:
[email protected]
Kristi Hustak
City: San Antonio RECRUITING
Facility: Hill Country Plastic Surgery
Contact Info:
[email protected]
210-658-3555
Amita Shah
Scott Farber
City: San Antonio RECRUITING
Facility: Next Stage Clinical Research
Contact Info:
[email protected]
210-998-7990
Earl Ferguson
Utah
City: Draper RECRUITING
Facility: The Plastics Clinic
Contact Info:
[email protected]
801-839-5557
Jerry Chidester
Washington
City: Seattle RECRUITING
Facility: Athenix Advanced Plastic Surgery & Aesthetic Center
Contact Info:
[email protected]
425-307-3546
Gavin Dry
City: Vancouver RECRUITING
Facility: Allen Gabriel MD
Contact Info:
[email protected]
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: [email protected]
Backup Contact:
Jenna Baccari
Email: [email protected]