Scaffold-guided Breast Surgery

Breast Implant Revision Clinical Trial

Official title: Clinical Trial Evaluating Medical-grade Polycaprolactone-PCL Breast Scaffold Implantation With Autologous Fat Grafting for Breast Implant Revision and Congenital Defect Correction Surgery

Status Active, not recruiting

Clinical Trial Summary

The clinical trial is testing the use of a novel method to grow new tissue within the breast injecting fat tissue harvested from patient's own fat deposits. A scaffold implant acts as a resorbable frame to support this growth of cells. The scaffold will be resorbed within at least 3 years. The main assumption of this clinical trial is that the method used is safe and effective for treatment of women requiring a silicone implant and /or correction of breast defect and/or deformity. The other assumption is that this method is applicable to a wider range of tissue defects, such as breast reconstruction after breast tissue removal. The new method is called '3D printed scaffold-based soft tissue regeneration', and uses a combination of own fat cells (called adipocytes) with a 3D printed scaffold to support soft tissue regeneration using the natural healing processes in their body. This substance is resorbable and is similar to the substance used for sutures and stitches that are dissolvable or resorbable in the body. The substance used for the scaffold is already Therapeutic Goods Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the their own tissue in its place. The combination of scaffold implantation and their own fat cells is the novel method in this trial. Conventional liposuction techniques are used from another site on the patients body to harvest their fat cells.

Clinical Trial Description

A 3D printed scaffold made of medical grade polycaprolactone is planned to be implanted for breast revision an/or congenital defect correction. First the patient will be thoroughly evaluated with history taking and examination to determine whether they are suitable for implantation. If deemed suitable for the trial, the surgeon together with the patient will choose the right scaffold size and fix a date for the surgery. All scaffolds are sterilized and transported in sealed packaging.

The implantation surgery will be done at a tertiary teaching hospital by an experienced breast surgeon and plastic and reconstructive surgeon. During the implantation procedure, the patient's own fat cells are harvested through simple liposuction techniques usually harvesting from the abdomen and thighs depending on availability of tissue. The fat cells that are harvested are then injected into the implanted scaffold at the time of initial implantation. The total length of procedure is estimated to take 2 hours.

Recovery from the operation can take up to one week. From that, the effectiveness, complications and side-effects will be monitored for up to two years. The patient progress will be evaluated daily after the procedure while they are in hospital with clinical assessment of the wounds and overall status. On discharge a number of surveys will be performed to document the progress at regular intervals, as well as MRI studies. The duration of follow up for the study is 2 years after implantation.

All appointments and clinical assessments will be documented in the electronic patient medical record as well as electronic Case Report Form (QH-REDCap database). ;

Related Conditions & MeSH terms

• Breast Implant Revision

• NCT number: NCT05437757
• Study type: Interventional
• Source: BellaSeno GmbH
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2022
• Completion date: December 17, 2025