Design of Protective Headgear for Patients Who Have Undergone a Craniectomy

Tan Tock Seng Hospital

Status: Unknown

Conditions: Craniectomy

Treatments: Device: Head protection device

Study type: Interventional

Funder types: Other

Identifiers

NCT05226741

2021/00540

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Head protection

Experimental group

Description:

Participants are given a form of head protection

Treatment:

Device: Head protection device