Novel Head Protection Prototype Device for Decompression Craniectomy — HPPD  

Stroke Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Brain Injuries
• Stroke

• NCT number: NCT04021095
• Study type: Interventional
• Source: Tan Tock Seng Hospital
• Status: Completed
• Phase: N/A
• Start date: July 4, 2019
• Completion date: March 31, 2021