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

N/AActive Not RecruitingNCT07122752

Tan Tock Seng Hospital32 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Traumatic Brain Injury Acquired Brain Injury Brain Tumor Stroke

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Tan Tock Seng Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

Treatment-emergent adverse events (safety and tolerability)

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).

Time frame: 30 minutes post fitting (version 1 and 2)

Patient Reported Outcome Measures (PROMS) PROMs (compliance)

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.

Time frame: 2023-2025

Patient Reported Outcome Measures (PROMS) PROMs (wearing time)

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.

Time frame: 2023-2025

Patient Reported Outcome Measures (PROMS) PROMs (adverse events)

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.

Time frame: 2023-2025

Patient Reported Outcome Measures (PROMS) PROMs (cosmesis rating)

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.

Time frame: 2023-2025

Data from ClinicalTrials.gov

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