The study evaluates a bioabsorbable scaffold designed to reduce the recurrence of capsular contracture in patients undergoing revision procedures.
BD reached an enrollment milestone in its STANCE clinical trial, which evaluates the GalaFLEX LITE Scaffold in breast revision surgery for capsular contracture, the company announced. The study has treated 274 patients across 33 active US sites, triggering the first planned interim analysis.
This milestone places enrollment beyond 50% of the trial’s maximum planned enrollment, which is expected to range from 250 to 530 patients under the study’s adaptive design.
Addressing Capsular Contracture Recurrence
Implant-based breast surgery is among the most common plastic surgery procedures in the US, and capsular contracture is its most frequent complication. The condition occurs when scar tissue around the implant hardens, which can cause pain and anatomical displacement. While incidence ranges from 10% to 20%, the risk of recurrence can be as high as 54% when advanced cases are treated with conventional surgical techniques.
“STANCE reflects our commitment to advancing innovation in soft tissue support and expanding the impact of advanced tissue regeneration in areas where patients continue to face significant clinical challenges,” says Art Stephen, global research and development leader of surgery at BD, in a release.
Stephen notes that the study is generating clinical evidence to support a new indication for the scaffold.
Study Design and Technology
The STANCE clinical trial is a prospective, randomized, controlled, multi-center study. It assesses the safety and efficacy of the GalaFLEX LITE Scaffold in revision surgery to reduce the recurrence of capsular contracture or malposition. Patients are randomized 2:1 to receive either the scaffold or standard care, which involves no supportive matrix or acellular dermal matrix placement.
“Capsular contracture remains a significant challenge in implant-based breast surgery, and robust clinical evidence is needed to advance patient care,” says Caroline Glicksman, MD, a board-certified plastic and reconstructive surgeon and the study’s national principal investigator, in a release.
The clinical data is intended to support a Food and Drug Administration Premarket Approval application for a breast indication.
The GalaFLEX LITE Scaffold is engineered to provide strength and stability during the wound healing period. It is composed of poly-4-hydroxybutyrate, a bioabsorbable and biologically derived polymer that has been used for more than a decade in hernia repair and other reconstructive procedures.
Photo caption: GalaFLEX LITE Scaffold
Photo credit: BD
