NCT07367698

Scaffold-guided Breast Implant Revision Surgery

Clinical Investigation Evaluating Medical Grade Polycaprolactone (PCL) Breast Scaffold Implantation in Conjunction With Autologous Fat Grafting for Breast Implant Revision Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: BellaSeno Pty Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical trial is to generate robust data that demonstrates clinical performance and safety of a polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) in women who seek a revision surgery of a breast implant used for breast augmentation. The material (PCL) has been in clinical use for many decades and is absorbable. This study follows the successful completion of a 2-year evaluation of the safety and feasibility of this technique performed by the Royal Brisbane and Women's Hospital (ClinicalTrials.gov ID: NCT05437757). The main question it aims to answer is: "Is PCL Breast Scaffold with autologous fat graft a safe and effective method of soft tissue reconstruction following breast implant revision?". Participants will: * Undergo removal of their existing silicone breast implant (if not previously removed), * Receive implantation of a PCL Breast Scaffold combined with autologous fat grafting (AFG), and * Attend follow-up visits at 1 week, 3 months, 6 months, and annually for up to 5 years for clinical assessments and questionnaires.

Conditions

• Breast Implant Revision
• Breast Augmentation Complications

Interventions

Type	Name	Description
DEVICE	Implantation of the PCL Breast scaffold with autologous fat grafting	The PCL Breast Scaffold is implanted either immediately following the removal of a silicone implant or during a delayed procedure. The surgery uses the same surgical pocket from the previous augmentation for insertion of the PCL Breast Scaffold, or, if implants have been previously removed, a new surgical pocket will be created. The PI will ensure accurate placement and secure fixation of the scaffold in the desired anatomical position. Autologous fat grafting (AFG) is then performed: the fat cells are harvested from the abdomen and/or thighs and injected into the implanted scaffold at the time of initial implantation. Lastly, after the AFG has been performed, wound closure and dressing will be conducted as per standard procedure. Sterile bandaging shall be initially applied and the wound reviewed daily whilst an inpatient. In conjunction with scaffold implantation, concurrent breast procedures may be performed on a case-by-case basis (e.g., Mastopexy,...).

Timeline

• Start date: 2026-02-13
• Primary completion: 2032-01-01
• Completion: 2032-01-01
• First posted: 2026-01-26
• Last updated: 2026-03-05

Locations

6 sites across 3 countries: Australia, Denmark, Germany