Design of Protective Headgear for Patients Who Have Undergone a Craniectomy

February 3, 2022 updated by: Tan Tock Seng Hospital
To design and create wearable head protection to be worn on a patient's head following a neurosurgical procedure (namely craniectomy and craniotomy

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

After being given informed consent, all participants will undergo the fitting and trial of a specially designed head protection for 6 weeks. Week 1 participants will be assessed and clinical data obtained on participants condition with the head protection fitted during the same session. Participants will return after 3 weeks for review and adjustment and again at the 6 week interval where they will also be given a questionnaire to fill up regarding their use and comfort.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects are eligible if they are 21 years or above and have had a DC >30 days, no wounds, able to understand simple commands and have a primary caregiver

Exclusion Criteria:

  • Exclusion criteria are patients with severe cognitive impairment, wounds, > unilateral DC, no caregiver

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Head protection
Participants are given a form of head protection
Device: Head protection device
The participants are fitted with a form of head protection over the craniectomy and provide feedback on design, use, and comfort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Survey
Time Frame: 6 weeks after receiving their head protection fitting
A survey to assess Satisfaction with device
6 weeks after receiving their head protection fitting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Euro Quality of Life - 5 Dimensions (EQ-5D)
Time Frame: 6 weeks after receiving their head protection fitting
Quality of life survey. The higher the score from 0-5 for each dimension, the higher the quality of life.
6 weeks after receiving their head protection fitting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Investigators

  • Principal Investigator: Trevor Binedell, Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

February 7, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021/00540

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonymised Information will be published in a journal once completed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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