19
Participants
Start Date
June 15, 2022
Primary Completion Date
December 17, 2025
Study Completion Date
December 17, 2025
Surgical implantation of the PCL Breast scaffold with autologous fat grafting
Single shot of prophylactic perioperative antibiotics is given to the patient. A suitable incision is made to provide access followed by mobilisation of the breast gland.If present, the silicone implant is removed and capsulectomy performed. The implant pocket shall be rinsed with saline or antiseptic and a surgical drain shall be placed in the pocket at the discretion of the PI. The PCL Breast scaffold shall be inserted into the pocket and fixed using 2 to 4 sutures. The incision is closed. Liposuction is performed from another area of the body and lipofilling is performed within the breast scaffold. Sterile bandaging is applied and a daily wound revision is performed whilst an inpatient. A prophylactic antibiotic shall be administered to the patient.The patients shall be hospitalized overnight for clinical observation.
Royal Brisbane and Women's Hospital (RBWH), Brisbane
BellaSeno Pty Ltd
INDUSTRY