A 3D printed scaffold made of medical grade polycaprolactone is planned to be implanted to correct pectus excavatum defects. First the patient will be thoroughly evaluated with history taking, examination and medical imaging to determine whether they are suitable for implantation. Imaging will take place as part of the work-up for the trial in the form of a CT scan and MRI. If the patient is deemed suitable for the trial, a custom-made scaffold for the patient chest wall defect is designed based on the medical imaging attained previously. This scaffold is then manufactured and sterilised, before being implanted.~The implantation surgery will be done at a tertiary teaching hospital by an experienced plastic and reconstructive surgeon. During the implantation procedure, the patient's own fat cells are harvested through simple liposuction tecnhniques, usually from the abdomen and thighs depending on the availability of the tissue. The fat cells that are harvested are then injected into the implanted scaffold at the time of implanation. The total length of procedure is estimated to take 1 hour.~The patients 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 recurrent MRI studies.~The effectiveness, complications and side-effects will be monitored for up to two years.~All appointments and clinical assessment will be documented in the electronic patient medical record as well as a secure de-identified trial database.
The clinical study is testing a new treatment for pectus excavatum called custom-made 3D printed scaffold-based soft tissue reconstruction. The new method uses a combination of the patients own adipocytes (fat cells) with a 3D printed scaffold (PCL Pectus Scaffold) to support soft tissue regeneration in the patient's chest using the body's natural healing processes.~The implanted scaffold acts as a resorbable frame to support the growth of cells. The substance used for the scaffold is resorbable, it's similar to the substance used for sutures and stitches, and it's already TGA approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the tissue in its place.