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

Conditions

• Capsular Contracture Associated With Breast Implant
• Capsular Contracture Grade III
• Capsular Contracture Grade IV

Eligibility Criteria

Sex

FEMALE

Age

22 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• GalaFLEX LITE™ Scaffold — DEVICE
  Bioabsorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB) and knitted into a surgical scaffold used to reinforce soft tissue
• Standard surgery — OTHER
  Surgery performed without the use of a scaffold

Study Details

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.

Key Dates

Start date

Dec 12, 2024

Status verified

May 2026

Primary completion

Feb 28, 2029

Completion

Feb 28, 2029

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: GalaFlex Light Scaffold
  Surgery performed with GalaFlex Lite Scaffold.
• Active Comparator: Standard Surgery
  Surgery performed using standard surgical procedures with no scaffold.

Primary Outcome Measure

Effectiveness of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket [ Time Frame: 24-months after index surgery ]

Central Contacts

• Niccole Diaz
  407-694-0553
  [email protected]
• Jenna Baccari
  [email protected]

Locations (34)

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