NCT05634070

Pectus Excavatum Camouflage (IT)

Clinical Trial Evaluating Medical-grade Polycaprolactone-PCL Pectus Scaffold Implantation with Autologous Fat Grafting for Pectus Excavatum Camouflage (IT)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: BellaSeno GmbH · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

A 3D printed custom-made scaffold made of medical-grade polycaprolactone (m-PCL) is planned to be implanted to correct pectus excavatum defects. Participants will be recruited at the Meyer Hospital (Florence, Italy). The patient is assessed clinically by the PI with a direct history and examination, in conjunction with the imaging reviewed by the Principal Investigator and his team. Imaging is organised through the Meyer Hospital imaging department and includes chest CT and MRI. Patients will be formally enrolled into the trial after written informed consent is obtained from the patients and from their parents/legal guardian (in case of minor patients). If the patient is deemed suitable and satisfy the inclusion and exclusion criteria, as assessed by the Principal Investigator and his team, a custom-made scaffold is designed based on his/her medical-imaging. The procedure for implantation of the scaffold is similar to the procedure for implantation of silicone implants. A small incision is made in the chest, a pre-sternal pocked is defined, following this an empty scaffold is implanted at the site of the defect (pectus excavatum) with skin closed directly over it. At the same intervention, autologous fat transfer is performed, harvesting fat from available donor sites such as the thighs and abdomen - depending on scaffold volume and patient morphology. The scaffold provides structural stability to the infiltration of the tissue inside the scaffold. Once the scaffold is fully absorbed, the tissue, which infiltrated it is expected to provide structural stability to the void defect and potentially ensuring a stable outcome. After the scaffold implantation and fat grafting procedure, patients will remain an inpatient for the necessary number of days after the surgery. In uncomplicated cases, patients will be reviewed at trial required follow up visits at 1, 3-, 6-, 12- and 24-months post-surgery. Each follow up visit will include routine clinical assessments, review of adverse events and medications, repeat MRI scans and completion of questionnaires for the patients. The focus of these assessments is to identify complications, while establishing clinical and radiological evidence of soft tissue retention. All appointments and clinical assessment will be documented in the patient medical record.

Conditions

• Pectus Excavatum

Interventions

Type	Name	Description
DEVICE	PCL Pectus scaffold implantation and autologous fat grafting	A suitable incision will be made using a scalpel and diathermy following standard surgical procedures.The implant pocket shall be rinsed with saline. The PCL Pectus Scaffold shall be inserted into the pocket following the Instruction for Use and fixed to the thoracic wall using 2 to 4 sutures. The device shall not be modified for any patient in any manner. The incision shall be closed using 2-0 Vicryl or Monocryl and 3-0 Monocryl sutures, if applicable. Number of layers to be sutured will be decided by the PI for each patient. Sterile bandaging as well as Steri-Strips shall be applied on the sutures. A prophylactic antibiotic such as Cefazolin 1g (3 shots per day x 2 days) shall be administered to the patient. In case the patient has Cefazolin allergy, Clindamycin 600 mg shall be prescribed. Autologous Fat Grafting procedure shall be performed immediately after implantation. The patients shall be hospitalized for the necessary number of days under clinical observation.

Timeline

• Start date: 2022-12-28
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2022-12-01
• Last updated: 2025-02-07

Locations

1 site across 1 country: Italy