Pectus Excavatum Camouflage (IT)

NAActive, not recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

December 28, 2022

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2027

Conditions
Pectus Excavatum
Interventions
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.

Trial Locations (1)

50139

Meyer Children's Univeristy Hospital, Florence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BellaSeno GmbH

INDUSTRY

NCT05634070 - Pectus Excavatum Camouflage (IT) | Biotech Hunter | Biotech Hunter