NCT04021095

Novel Head Protection Prototype Device for Decompression Craniectomy

An Exploratory Study on the Development of a Novel Head Protection Prototype Device for Post-decompression Craniectomy Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tan Tock Seng Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A proof-of-concept (POC) proposal to study the feasibility of customized head protection prototype device (HPPD) using 3D printed externally-applied moulded skin prosthesis integrated to the craniectomy bony skull defect.

Detailed description

A proof-of-concept (POC) proposal to study the feasibility of customized head protection prototype device (HPPD) using 3D printed externally-applied moulded skin prosthesis integrated to the craniectomy bony skull defect. The proposed material is a bio-compatible, light-weight rigid /semi rigid material which can be fitted to the skull defect and interfaced with the subject's bony rim using soft, deformable material (e.g. silicon) and attached using an elastic head band or other acceptable means. The prosthesis is removable for skin and prosthesis cleansing and ventilation. Study Specific Objectives: (i) Primary Objectives These are to: 1. test the feasibility and safety of customised 3D printed HPPD, 2. integrate the prostheses to the skull defect in removable manner and discharge patient with appropriate education, 3. to systematically monitor subjects for symptoms, compliance, complications and subjective feedback during the outpatient phase where progressive wear of HPPD and monitoring of acceptability will be monitored.

Conditions

• Brain Injuries
• Stroke

Interventions

Type	Name	Description
DEVICE	Head protection prototype device	The proposed experimental HPPD uses biocompatible material using FDMÔNylon which has high fatigue resistance, chemical resistance with impact resistance and toughness which is free of powders. It is HSA unclassified as yet and the FDMONylon is not FDA approved yet.

Timeline

• Start date: 2019-07-04
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2019-07-16
• Last updated: 2021-04-01

Locations

1 site across 1 country: Singapore