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Design of Protective Headgear for Patients Who Have Undergone a Craniectomy

Design of Protective Headgear for Patients Who Have Undergone a Craniectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05226741
Enrollment
5
Registered
2022-02-07
Start date
2021-11-11
Completion date
2022-03-31
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniectomy

Keywords

helmet, protection,

Brief summary

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

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.

Interventions

DEVICEHead protection device

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

Sponsors

Tan Tock Seng Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
Patient Satisfaction Survey6 weeks after receiving their head protection fittingA survey to assess Satisfaction with device

Secondary

MeasureTime frameDescription
Euro Quality of Life - 5 Dimensions (EQ-5D)6 weeks after receiving their head protection fittingQuality of life survey. The higher the score from 0-5 for each dimension, the higher the quality of life.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026