The clinical study evaluates the use of a custom-made medical-grade polycaprolactone-PCL Pectus scaffold implantation with Autologous Fat Grafting for pectus excavatum camouflage (IT). The study aims to demonstrate the safety and clinical performance of the insertion of an absorbable "medical-grade polycaprolactone-PCL Pectus Scaffold" in the thorax region with Autologous Fat Grafting in the correction of congenital Pectus Excavatum unsuitable for conventional treatment with stable cardio-respiratory function.
The PCL Pectus Scaffold-based design has the potential to induce sustained regeneration to fill large volume pectus excavatum defects, with the added benefit of being light weight and resorbable, thus not affecting the patients function capacity and reducing the risk of implant-related complications.
Who can participate
Age range14 Years
SexALL
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Inclusion criteria
✓. Genetic female patients of age 14 years and up OR Genetic male patients of age 16 years and up without cardiopulmonary compromise seeking correction or improvement of pectus excavatum-associated with anterior chest wall deformity and/or congenital defect.
✓. Patient willing and able to comply with the study requirements (e.g., all scheduled appointments).
✓. Patient is eligible to undergo MRI (i.e., no implanted metal or metal devices, no history of severe claustrophobia).
✓. Patient and his/her parents/legal guardian (in case of minor patients) capable of providing valid written informed consent.
✓. Have sufficient body fat for homologous transplantation.
✓. The patient/Guardian has "realistic" expectations of surgical results as determined by the PI.
Exclusion criteria
✕. Genetic females less than 14 years of age at the time of surgery.
✕. Genetic males less than 16 years of age at the time of surgery.
What they're measuring
1
Rate of adverse events and serious adverse events from the time of surgery to the end of study visit.
Timeframe: Assessed at 24 post-surgery months
2
Change in (fat) volume % and soft tissue retention % within the scaffold (radiological and/or clinical) from the time of surgery to the end of study visit using radiological and clinical assessments
Timeframe: Assessed at 1-,6-,12-,24-months post-surgery
3
Preservation of pre-operative functional status
Timeframe: Assessed at 12-months post-surgery
4
Change in pain assessments from baseline to the end of study visit
Timeframe: Assessed at 1-month post surgery
5
Change in wound healing from the time of surgery to the end of study visit
Timeframe: Assessed at 1-month post surgery
6
Change in patient quality of life as assessed by Quality of Life (QoL) questionnaires from baseline to the end of study visit
Timeframe: Assessed at 3, 6, 12 and 24 month - clinical review
✕. Patient chest wall tissue is clinically incompatible for the procedure as determined by PI.
✕. Compromised vascularity in the pectoralis muscle and subcutaneous tissue.
✕. Patient and is/her parents/legal guardian (in case of minor patients) unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment.
✕. Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy, or other cause for secondary/primary immunodeficiency.
✕. Known severe concurrent or inter-current illness including cardiovascular, respiratory, or immunological illness, psychiatric disorders, alcohol or chemical dependence, possible allergies that would, in the opinion of the Co-ordinating Principal Investigator, compromise their safety or compliance or interfere with interpretation of study results.