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Novel Head Protection Prototype Device for Decompression Craniectomy (HPPD)

Primary Purpose

Brain Injuries, Stroke

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Head protection prototype device

About this trial

This is an interventional other trial for Brain Injuries

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Tan Tock Seng Hospital Rehabilitation Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Decompressive craniectomy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04021095

First Posted

July 11, 2019

Last Updated

March 31, 2021

Sponsor

Tan Tock Seng Hospital

Collaborators

Creatz3D

1. Study Identification

Unique Protocol Identification Number

NCT04021095

Brief Title

Novel Head Protection Prototype Device for Decompression Craniectomy

Acronym

HPPD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

July 4, 2019 (Actual)

Primary Completion Date

March 31, 2021 (Actual)

Study Completion Date

March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tan Tock Seng Hospital

Collaborators

Creatz3D

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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: test the feasibility and safety of customised 3D printed HPPD, integrate the prostheses to the skull defect in removable manner and discharge patient with appropriate education, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injuries, Stroke

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Customised head protection prototype device.

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Decompressive craniectomy

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Head protection prototype device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of acute complications at second hour of HPPD fitting

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Khai Pang Leong

Organizational Affiliation

Tan Tock Seng Hospital Clinical research and innovation office

Official's Role

Study Director

Facility Information:

Facility Name

Tan Tock Seng Hospital Rehabilitation Centre

City

Singapore

ZIP/Postal Code

569766

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Learn more about this trial

Novel Head Protection Prototype Device for Decompression Craniectomy

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