Feasibility, Safety and Patient Reported Outcomes of 3D-Printed Externally-applied Cranial Orthosis (PEACO) After Decompression Craniectomy in Clinical Settings: A Retrospective Comparison Study of Monitored Versus Unmonitored Protocols
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Patient Reported Outcome Measures (PROMS) PROMs (compliance)
研究概览
简要总结
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.
详细描述
The study aims to:
- Evaluate the feasibility, safety and clinical outcomes of a 3D-printed externally applied cranial orthosis (PEACO) in a clinical setting (unmonitored protocol)
- Comparison of device A - 2021 Head Protection Prototype Device (HPPD) (DSRB 2019/00155)-monitored protocol with device B (PEACO).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral decompressive craniectomy (DC)
- •Acute Stroke or traumatic brain injury
- •>30 days post DC
- •Healed surgical wounds, non-bulging flaps
- •Presence of caregiver supervision
排除标准
- •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
结局指标
主要结局
Patient Reported Outcome Measures (PROMS) PROMs (compliance)
时间窗: 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.
Treatment-emergent adverse events (safety and tolerability)
时间窗: 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 (wearing time)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Chua Sui Geok, Karen
Senior Consultant Dr (MD)
Tan Tock Seng Hospital