Status:
COMPLETED
Novel Head Protection Prototype Device for Decompression Craniectomy
Lead Sponsor:
Tan Tock Seng Hospital
Collaborating Sponsors:
Creatz3D
Conditions:
Brain Injuries
Stroke
Eligibility:
All Genders
21-80 years
Phase:
NA
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 craniecto...
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 craniecto...
Eligibility Criteria
Inclusion
- All subjects must meet all of the inclusion criteria to participate in this study.
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04021095
Start Date
July 4 2019
End Date
March 31 2021
Last Update
April 1 2021
Active Locations (1)
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1
Tan Tock Seng Hospital Rehabilitation Centre
Singapore, Singapore, 569766