Novel Head Protection Prototype Device for Decompression Craniectomy

NCT04021095 | Completed

• 1 other identifier: DSRB2019/00155
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Injuries; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of acute complications at end of first week of HPPD use.

  12 months

Study Arms (1)

Decompressive craniectomy

EXPERIMENTAL

3D printed skull replacement piece will be fitted to subject.

Device: Head protection prototype device

Interventions

Head protection prototype device 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.

Decompressive craniectomy

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 to 80 years, both males and females.
• 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.
• Stroke, SAH or TBI are diagnosed by specialists and confirmed on brain imaging studies (CT, MRI)
• Duration from event \> 30 days and either during inpatient or outpatient phase.
• Presence of at least 1 post decompressive craniectomy CT brain film performed at NNI/TTSH.
• Healed craniectomy surgical wound without bulging skin flap or active skin infection.
• 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

You may not qualify if:

• Patient in vegetative or minimally responsive state.
• Presence of uncontrolled medical condition (uncontrolled hypertension, Diabetes Mellitus, sepsis or delirium, active malignancy either cranial or extracranial sites)
• Presence of end organ failure (end stage renal or liver failure, renal dialysis, life expectancy \<6 months)
• Presence of pregnancy or lactation.
• Presence of severe agitation /behavioural/active depression or anxiety/ drug or alcohol addiction which would negatively affect compliance,
• Presence of unhealed head wound, active wound infection, scalp dermatitis, wound breakdown which would be worsened by pressure from the HPPD.
• Presence of known allergy to the investigational products which is the 3D printed material (e.g. Nylon).
• Subjects' CT brain imaging films are not available to the study team.
• Absence of NOK who can assist monitoring unless subjects is able to self-monitor

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Creatz3D: collaborator

Study Sites (1)

Tan Tock Seng Hospital Rehabilitation Centre

Singapore, 569766, Singapore

Location

MeSH Terms

Conditions

Brain Injuries; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Khai Pang Leong

  Tan Tock Seng Hospital Clinical research and innovation office

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Customised head protection prototype device.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 16, 2019
• Study Start: July 4, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 1, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)