Feasibility and Outcomes of 3D-printed External Cranial Orthosis After Craniectomy

Active, not recruiting

• Conditions: Traumatic Brain Injury; Acquired Brain Injury; Brain Tumor; Stroke

• Registration Number: NCT07122752
• Lead Sponsor: Tan Tock Seng Hospital

Brief Summary

This study will compare the outcomes of a current clinical implementation of PEACO designed for one-handed donning and doffing with carer-monitoring with a previous prototype (HPPD) requiring carer-donning and doffing with therapist monitoring.

Detailed Description

The study aims to:

1. Evaluate the feasibility, safety and clinical outcomes of a 3D-printed externally applied cranial orthosis (PEACO) in a clinical setting (unmonitored protocol)

2. Comparison of device A - 2021 Head Protection Prototype Device (HPPD) (DSRB 2019/00155)-monitored protocol with device B (PEACO).

Study Timeline

• Study Start: 2025-07-29
• Study First Submitted: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2026-08-29
• Study Completion: 2026-08-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Unilateral decompressive craniectomy (DC)
• Acute Stroke or traumatic brain injury
• >30 days post DC
• Healed surgical wounds, non-bulging flaps
• Presence of caregiver supervision

Exclusion Criteria

• Vegetative or minimally responsive state
• Uncontrolled medical illnesses, e.g. sepsis, delirium, active malignancy
• Life expectancy < 6 months
• Unhealed or infected post-DC neurosurgical wounds
• Known allergy to investigational products

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events (safety and tolerability)	30 minutes post fitting (version 1 and 2)	The therapist will assess patient in terms of pain, redness, skin imprints and pruritus' on patient's skin after wearing the cranial cap. This is to allow the understanding of the incidence of the treatment-emergent adverse events (safety and tolerability).
Patient Reported Outcome Measures (PROMS) PROMs (compliance)	2023-2025	The patient will be sent a questionnaire. The question relating to compliance is "Approximately, how many hours of wear per day including rest breaks?" This will allow team to assess feasibility, safety and clinical outcomes.
Patient Reported Outcome Measures (PROMS) PROMs (wearing time)	2023-2025	The patient will be sent a questionnaire. The question relating to wearing time is "Approximately, how many hours of wear per day including rest breaks?" This will allow team to assess feasibility, safety and clinical outcomes.
Patient Reported Outcome Measures (PROMS) PROMs (adverse events)	2023-2025	The patient will be sent a questionnaire. The question relating to adverse event is "Did you experience any of the following after two hours of wear? This will allow team to assess feasibility, safety and clinical outcomes.
Patient Reported Outcome Measures (PROMS) PROMs (cosmesis rating)	2023-2025	The patient will be sent a questionnaire. The question relating to cosmesis rating is "Please rate the appearance of your cranial cap". This will allow team to assess feasibility, safety and clinical outcomes.

Trial Locations

Locations (1)

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore