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出境医 / 临床实验 / Novel Head Protection Prototype Device for Decompression Craniectomy (HPPD)

Novel Head Protection Prototype Device for Decompression Craniectomy (HPPD)

Study Description
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.

Condition or disease Intervention/treatment Phase
Brain Injuries Stroke Device: Head protection prototype device Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Customised head protection prototype device.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Exploratory Study on the Development of a Novel Head Protection Prototype Device for Post-decompression Craniectomy Patients
Actual Study Start Date : July 4, 2019
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Decompressive craniectomy
3D printed skull replacement piece will be fitted to subject.
 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.
Outcome Measures
Primary Outcome Measures :
  1. Percentage of acute complications at second hour of HPPD fitting [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Percentage of acute complications at end of first week of HPPD use. [ Time Frame: 12 months ]
    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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Singapore
Tan Tock Seng Hospital Rehabilitation Centre
Singapore, Singapore, 569766
Sponsors and Collaborators
Tan Tock Seng Hospital
Creatz3D
Investigators
Layout table for investigator information
Study Director: Khai Pang Leong Tan Tock Seng Hospital Clinical research and innovation office
Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE July 4, 2019
Actual Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019) 		Percentage of acute complications at second hour of HPPD fitting [ Time Frame: 12 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019) 		Percentage of acute complications at end of first week of HPPD use. [ Time Frame: 12 months ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Novel Head Protection Prototype Device for Decompression Craniectomy
Official Title  ICMJE An Exploratory Study on the Development of a Novel Head Protection Prototype Device for Post-decompression Craniectomy Patients
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Customised head protection prototype device.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Brain Injuries
  • Stroke
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Decompressive craniectomy
3D printed skull replacement piece will be fitted to subject.
Intervention: Device: Head protection prototype device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 31, 2021
Actual Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04021095
Other Study ID Numbers  ICMJE DSRB2019/00155
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Due to the visual nature of the study data (digital photo facial images), only study team researchers will have access to identifiable participant data and images.
Responsible Party Tan Tock Seng Hospital
Study Sponsor  ICMJE Tan Tock Seng Hospital
Collaborators  ICMJE Creatz3D
Investigators  ICMJE
Study Director: Khai Pang Leong Tan Tock Seng Hospital Clinical research and innovation office
PRS Account Tan Tock Seng Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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