Novel Head Protection Prototype Device for Decompression Craniectomy

Stroke Clinical Trial

— HPPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04021095
• Other study ID #: DSRB2019/00155
• Status: Completed
• Phase: N/A
• Start date: July 4, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: November 2019
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

All subjects must meet all of the inclusion criteria to participate in this study.

1. Age 21 to 80 years, both males and females.

2. Presence of surgical unilateral or bilateral craniectomy performed for reasons of ischaemic or haemorrhagic stroke, Subarachnoid haemorrhage (SAH), traumatic brain injury (TBI), benign cerebral tumours, etc.

3. Stroke, SAH or TBI are diagnosed by specialists and confirmed on brain imaging studies (CT, MRI)

4. Duration from event > 30 days and either during inpatient or outpatient phase.

5. Presence of at least 1 post decompressive craniectomy CT brain film performed at NNI/TTSH.

6. Healed craniectomy surgical wound without bulging skin flap or active skin infection.

7. Patients awaiting elective cranioplasty or those who refuse cranioplasty. 8 Ability to understand simple instructions and give own consent. 9 Presence of family members or NOK who can supervise the patient to don the head protection device, care for the material and regularly monitor for compliance and complications 10 Reproductive age females should not be pregnant at the point of consent-taking and during the study

Exclusion Criteria:

1. Patient in vegetative or minimally responsive state.

2. Presence of uncontrolled medical condition (uncontrolled hypertension, Diabetes Mellitus, sepsis or delirium, active malignancy either cranial or extracranial sites)

3. Presence of end organ failure (end stage renal or liver failure, renal dialysis, life expectancy <6 months)

4. Presence of pregnancy or lactation.

5. Presence of severe agitation /behavioural/active depression or anxiety/ drug or alcohol addiction which would negatively affect compliance,

6. Presence of unhealed head wound, active wound infection, scalp dermatitis, wound breakdown which would be worsened by pressure from the HPPD.

7. Presence of known allergy to the investigational products which is the 3D printed material (e.g. Nylon).

8. Subjects' CT brain imaging films are not available to the study team.

9. Absence of NOK who can assist monitoring unless subjects is able to self-monitor

Related Conditions & MeSH terms

• Brain Injuries
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital Rehabilitation Centre	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Creatz3D

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of acute complications at second hour of HPPD fitting	Complications are defined as immediate complaints of pain or discomfort and /or signs of bony defect scar pressure redness or wound breakdown within the first 2 hours in the research clinic.	12 months
Secondary	Percentage of acute complications at end of first week of HPPD use.	Complications are defined as pain or discomfort or signs of bony defect scar pressure or redness or wound breakdown in the first week post-fitting of HPPD	12 months