Clinical trial · Observational
Feasibility and Outcomes of 3D-printed External Cranial Orthosis After Craniectomy
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
NCT07122752CI-TRIAL-00093659active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acquired Brain Injury | — | UNRESOLVED | — |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Stroke | — | UNRESOLVED | — |
| Traumatic Brain Injury | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Version 1 Head protection Device 2021
- description
- Version 2 Head protection device 2025
Primary outcomes (5)
- measure
- Treatment-emergent adverse events (safety and tolerability)
- timeFrame
- 30 minutes post fitting (version 1 and 2)
- description
- 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).
- measure
- Patient Reported Outcome Measures (PROMS) PROMs (compliance)
- timeFrame
- 2023-2025
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDChua 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. PMID 34710123
- BACKGROUNDFernandez 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. PMID 39248525
- BACKGROUNDMa 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. PMID 40108252