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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Version 1 Head protection Device 2021 | Version 2 Head protection device 2025 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 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. | 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. | 2023-2025 |
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Inclusion Criteria:
Exclusion Criteria:
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NA as no patient is recruited for this study as the outcomes involve retrospective data as part of a clinical service audit.
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| Name | Affiliation | Role |
|---|---|---|
| Dr Karen Chua, MBBS | Tan Tock Seng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tan Tock Seng Hospital | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34710123 | Background | Chua KSG, Krishnan RR, Yen JM, Plunkett TK, Soh YM, Lim CJ, Chia CM, Looi JC, Ng SG, Rao J. 3D-printed external cranial protection following decompressive craniectomy after brain injury: A pilot feasibility cohort study. PLoS One. 2021 Oct 28;16(10):e0258296. doi: 10.1371/journal.pone.0258296. eCollection 2021. | |
| 39248525 | Background |
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no new IP generated
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001932 | Brain Neoplasms |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| Fernandez LL, Rodriguez D, Griswold DP, Khun I, Aristizabal S, Aristizabal JH, Richards G, Pavek A, Jayaraman S. Innovative External Cranial Devices for Protecting a Craniectomy Site: A Scoping Review on Noninvasive Approaches for Patients Awaiting Cranioplasty. Neurosurgery. 2025 Apr 1;96(4):713-724. doi: 10.1227/neu.0000000000003157. Epub 2024 Sep 9. |
| 40108252 | Background | Ma S, Li C, Gu Y, Chen Y, Li X, Wang Q, Xu H. Application of a 3D printed wig protection device after decompressive craniectomy. Sci Rep. 2025 Mar 19;15(1):9545. doi: 10.1038/s41598-025-94246-0. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |