PLoS ONE (Jan 2021)

3D-printed external cranial protection following decompressive craniectomy after brain injury: A pilot feasibility cohort study.

  • Karen Sui Geok Chua,
  • Rathi Ratha Krishnan,
  • Jia Min Yen,
  • Tegan Kate Plunkett,
  • Yan Ming Soh,
  • Chien Joo Lim,
  • Catherine M Chia,
  • Jun Cong Looi,
  • Suan Gek Ng,
  • Jai Rao

DOI
https://doi.org/10.1371/journal.pone.0258296
Journal volume & issue
Vol. 16, no. 10
p. e0258296

Abstract

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Objectives3D-printed (3DP) customized temporary cranial protection solutions following decompressive craniectomy (DC) are currently not widely practiced. A pilot trial of a 3DP customized head protection prototype device (HPPD) on 10 subjects was conducted during the subacute rehabilitation phase.Materials and methodsSubjects > 30 days post-DC with stable cranial flaps and healed wounds were enrolled. HPPD were uniquely designed based on individuals' CT scan, where the base conformed to the surface of the individual's skin covering the cranial defect, and the lateral surface three-dimensionally mirrored, the contralateral healthy head. Each HPPD was fabricated using the fused deposition modeling method. These HPPD were then fitted on subjects using a progressive wearing schedule and monitored over 1, 2, 4, 6 and 8 follow-up (FU) weeks. Outcomes during FU included; reported wearing time/day (hours), subjective pain, discomfort, pruritus, dislodgment, cosmesis ratings; and observed wound changes. The primary outcome was safety and tolerability without pain or wound changes within 30 minutes of HPPD fitting.ResultsIn all, 10 enrolled subjects received 12 HPPDs [5/10 male, mean (SD) age 46 (14) years, mean (SD) duration post-DC 110 days (76)] and all subjects tolerated 30 minutes of initial HPPD fitting without wound changes. The mean (SD) HPPD mass was 61.2 g (SD 19.88). During 8 weeks of FU, no HPPD-related skin dehiscence was observed, while 20% (2/10) had transient skin imprints, and 80% (8/10) reported self-limiting pressure and pruritis.DiscussionFindings from this exploratory study demonstrated preliminary feasibility and safety for a customized 3DP HPPD for temporary post-DC head protection over 8 weeks of follow-up. Monitoring and regular rest breaks during HPPD wear were important to prevent skin complications.ConclusionThis study suggests the potential for wider 3DP technology applications to provide cranial protection for this vulnerable population.