Design of Protective Headgear for Patients Who Have Undergone a Craniectomy
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Patient Satisfaction Survey [6 weeks after receiving their head protection fitting]
A survey to assess Satisfaction with device
Secondary Outcome Measures
- Euro Quality of Life - 5 Dimensions (EQ-5D) [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tan Tock Seng Hospital | Singapore | Singapore | 308433 |
Sponsors and Collaborators
- Tan Tock Seng Hospital
Investigators
- Principal Investigator: Trevor Binedell, Tan Tock Seng Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Colasante C, Sanford Z, Castro N, Bartels MN. Custom Fabrication of a 3-Dimensionally Printed Helmet for Improved Socialization and Subjective Self-Assessment in a Case of Acquired Cranial Defect: A Case Presentation. PM R. 2018 Jun;10(6):671-674. doi: 10.1016/j.pmrj.2017.11.005. Epub 2017 Dec 30.
- Lucano LRG, Brambila FJP, Pérez JE, Rosales PH. Customized Low-Cost 3D Printed Helmet as a Temporary Measure for a Patient with Acrania. Indian J Plast Surg. 2019 May;52(2):252-253. doi: 10.1055/s-0039-1696077. Epub 2019 Sep 12.
- 2021/00540