NCT05945329

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: C. R. Bard · Industry
• Sex: Female
• Age: 22 Years – 66 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2024-12-12
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2023-07-14
• Last updated: 2026-03-10

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated device study