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

NCT07122752 | Active Not Recruiting

• 1 other identifier: DSRB 2025/1218
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Acquired Brain Injury; Brain Tumor; Stroke

Keywords

Cranial Orthosis; 3D Printing; Decompression Craniectomy; Retrospective Study; Head Protection Device; Monitored Protocol; Unmonitored Protocol

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Version 1 Head protection Device 2021

Version 2 Head protection device 2025

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NA as no patient is recruited for this study as the outcomes involve retrospective data as part of a clinical service audit.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

Location

Related Publications (3)

• 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.

  PMID: 34710123 BACKGROUND

• 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.

  PMID: 39248525 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.

  PMID: 40108252 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries; Brain Neoplasms; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dr Karen Chua, MBBS

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant Dr (MD)

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 14, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): August 29, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)