Scaffold-guided Breast Surgery

NAActive, not recruitingINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

June 15, 2022

Primary Completion Date

December 17, 2025

Study Completion Date

December 17, 2025

Conditions
Breast Implant RevisionCongenital Breast Defect Correction
Interventions
DEVICE

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.

Trial Locations (1)

QLD 4029

Royal Brisbane and Women's Hospital (RBWH), Brisbane

All Listed Sponsors
lead

BellaSeno Pty Ltd

INDUSTRY

NCT05437757 - Scaffold-guided Breast Surgery | Biotech Hunter | Biotech Hunter