New mesh aims to stop painful breast implant scarring
NCT ID NCT05945329
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.
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Contacts and locations
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Study contacts
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Contact
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Locations
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Aesthetic Center for Plastic Surgery
RECRUITINGHouston, Texas, 77024, United States
Contact Email: •••••@•••••
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Aesthetic Enhancements Plastic Surgery
RECRUITINGOrlando, Florida, 32819, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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Allen Gabriel MD
RECRUITINGVancouver, Washington, 98660, United States
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Contact Email: •••••@•••••
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Athenix Advanced Plastic Surgery & Aesthetic Center
RECRUITINGSeattle, Washington, 98005, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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Beauty by Buford
RECRUITINGLone Tree, Colorado, 80124, United States
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Billington Plastic Surgery
RECRUITINGSt. Petersburg, Florida, 33710, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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California Aesthetic Center
RECRUITINGHuntington Beach, California, 92647, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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Careaga Plastic Surgery
RECRUITINGMiami, Florida, 33134, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Charlie Chen MD., Corp
RECRUITINGSan Diego, California, 92107, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Defyne MD
RECRUITINGScottsdale, Arizona, 82521, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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Donald S Mowlds, MD A Professional Corporation
RECRUITINGNewport Beach, California, 92660, United States
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Essential Medical Research
WITHDRAWNTulsa, Oklahoma, 74137, United States
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Farah Naz Khan
RECRUITINGDallas, Texas, 75219, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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H/K/B Surgery
RECRUITINGHuntersville, North Carolina, 28078, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hill Country Plastic Surgery
RECRUITINGSan Antonio, Texas, 78257, United States
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Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Meridian Plastic Surgery Center
RECRUITINGIndianapolis, Indiana, 46290, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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Monarch Plastic Surgery and Skin Renewal Center
RECRUITINGAtlanta, Georgia, 30328, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Newport Plastic and Reconstructive Surgery Associates
RECRUITINGNewport Beach, California, 92660, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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Next Stage Clinical Research
TERMINATEDSan Antonio, Texas, 78258, United States
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Northshore Plastic Surgery
RECRUITINGMandeville, Louisiana, 70448, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Pittsburgh Center for Plastic Surgery
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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Plastic Surgery Institute of New York
RECRUITINGNew York, New York, 10036, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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Reno Tahoe Plastic Surgery
RECRUITINGReno, Nevada, 89511, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Sanctuary Plastic Surgery
WITHDRAWNBoca Raton, Florida, 33431, United States
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Southwest Plastic Surgery
RECRUITINGEl Paso, Texas, 79936, United States
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Contact Email: •••••@•••••
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Stewart Wang MD Inc.
RECRUITINGPasadena, California, 91101, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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The Graivier Center
RECRUITINGAlpharetta, Georgia, 30005, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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The Plastic Surgery Center of Nashville With HKB
RECRUITINGNashville, Tennessee, 37203, United States
Contact Email: •••••@•••••
Contact Phone: •••-•••-•••• Email: •••••@•••••
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The Plastics Clinic
RECRUITINGDraper, Utah, 84020, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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The Practice Plastic Surgery
RECRUITINGBeverly Hills, California, 90210, United States
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The Washington University
RECRUITINGSt Louis, Missouri, 63110, United States
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Tim Sayed MD
WITHDRAWNSan Diego, California, 92121, United States
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VIP Plastic Surgery
RECRUITINGWest Long Branch, New Jersey, 07764, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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VIVIFY Plastic Surgery
RECRUITINGTampa, Florida, 33606, United States
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Contact Phone: •••-•••-•••• Email: •••••@•••••
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