Design of Protective Headgear for Patients Who Have Undergone a Craniectomy

Craniectomy Clinical Trial

Official title:

Design of Protective Headgear for Patients Who Have Undergone a Craniectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05226741
• Other study ID #: 2021/00540
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: March 2022

Study information

• Verified date: February 2022
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Craniectomy

Intervention

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

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction Survey	A survey to assess Satisfaction with device	6 weeks after receiving their head protection fitting
Secondary	Euro Quality of Life - 5 Dimensions (EQ-5D)	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