Design of Protective Headgear for Patients Who Have Undergone a Craniectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-03-31

Brief Summary

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To design and create wearable head protection to be worn on a patient's head following a neurosurgical procedure (namely craniectomy and craniotomy

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Detailed Description

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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.

Conditions

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Craniectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Head protection

Participants are given a form of head protection

Group Type EXPERIMENTAL

Head protection device

Intervention Type DEVICE

The participants are fitted with a form of head protection over the craniectomy and provide feedback on design, use, and comfort

Interventions

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Head protection device

The participants are fitted with a form of head protection over the craniectomy and provide feedback on design, use, and comfort

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No