ArticlePloS one2021
3D-printed external cranial protection following decompressive craniectomy after brain injury: A pilot feasibility cohort study.
Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07122752 (Feasibility, Safety and Patient Reported Outcomes of 3D-Printed Externally-applied Cranial Orthosis), which is not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
4 citing papers in PubMed, 8 citations in OpenAlex.
- Beyond the bone flap: integrating biomarkers, imaging, and emerging technologies in the surgical continuum of acute subdural hematoma (ASDH).Annals of medicine and surgery (2012) · 2026Review
- A personalized 3D printed cranial shield using mirror-image modeling: design and clinical assessment.3D printing in medicine · 2025Article
- Application of a 3D printed wig protection device after decompressive craniectomy.Scientific reports · 2025Article
- Effectiveness of Additive Manufactured Titanium Implants in the Reconstruction of Large Cranial Defects: Case Series and Review of Literature.Journal of maxillofacial and oral surgery · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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. DISCUSSION: Findings 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.
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Registered trials
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