Randomized Study of GalaFLEX LITE Scaffold Versus Standard Surgery for Treating Capsular Contracture After Breast Implant Augmentation

What this Trial Is About

Researchers are investigating the use of the GalaFLEX LITE Scaffold in revision surgeries for women who experience capsular contracture, a common complication after breast implant augmentation. This study compares the scaffold to standard revision surgery without any supportive matrix or acellular dermal matrix ADM, aiming to reduce the recurrence of capsular contracture and implant malposition. The trial is prospective, randomized, and controlled, involving women with Baker grade III or IV capsular contracture. Participants will be randomly assigned in a 21 ratio to receive surgery either with the GalaFLEX LITE Scaffold, a bioabsorbable surgical mesh made from poly-4-hydroxybutyrate P4HB designed to reinforce soft tissue, or standard surgery without any scaffold. The number of treated breasts will range between 250 and 530. The study uses an adaptive design and includes a follow-up of up to 24 months to assess outcomes. During the study, participants will be monitored through various visits over two years. Researchers will evaluate the scaffolds effectiveness in stabilizing the implant pocket, reduce capsular contracture recurrence or implant malposition, and assess safety within 90 days post-surgery. Quality of life and patient satisfaction will also be measured at 12 and 24 months. Participants will complete an electronic patient diary using compatible smart technology and attend scheduled study visits to support adherence and data collection.

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