Tan Tock Seng Rehabilitation Centre, Tan Tock Seng Hospital, Singapore, Singapore.
Clinical Research and Innovation Office, Tan Tock Seng Hospital, Singapore, Singapore.
PLoS One. 2021 Oct 28;16(10):e0258296. doi: 10.1371/journal.pone.0258296. eCollection 2021.
3D-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.
Subjects > 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.
In 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.
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.
This study suggests the potential for wider 3DP technology applications to provide cranial protection for this vulnerable population.
目前，减压性颅骨切除术（DC）后使用 3D 打印（3DP）定制的临时颅保护解决方案并不广泛应用。在亚急性康复阶段，对 10 名受试者进行了 3DP 定制头保护原型设备（HPPD）的试点试验。
纳入 DC 后>30 天且颅骨瓣稳定、伤口愈合的受试者。根据个体的 CT 扫描，独特地设计 HPPD，其中基底符合覆盖颅骨缺损的个体皮肤表面，外侧表面三维镜像对侧健康头部。使用熔丝制造方法制造每个 HPPD。然后，使用渐进式佩戴时间表将这些 HPPD 贴合在受试者身上，并在 1、2、4、6 和 8 次随访（FU）周进行监测。FU 期间的结果包括：报告的佩戴时间/天（小时）、主观疼痛、不适、瘙痒、移位、美观评分；以及观察到的伤口变化。主要结果是在 HPPD 贴合后 30 分钟内无疼痛或伤口变化的安全性和耐受性。
总共 10 名入组受试者接受了 12 个 HPPD[5/10 名男性，平均（SD）年龄 46（14）岁，DC 后平均（SD）时间 110 天（76）]，所有受试者在无伤口变化的情况下耐受了 30 分钟的初始 HPPD 贴合。HPPD 的平均（SD）质量为 61.2 克（SD19.88）。在 8 周的 FU 期间，未观察到与 HPPD 相关的皮肤裂开，而 20%（2/10）有短暂的皮肤印记，80%（8/10）报告有自限性的压力和瘙痒。
这项探索性研究的结果表明，在 8 周的随访中，使用定制的 3DP HPPD 临时保护减压性颅骨切除术后的头部具有初步的可行性和安全性。在佩戴 HPPD 期间进行监测和定期休息非常重要，可以预防皮肤并发症。
这项研究表明，3DP 技术的潜在应用可以为这一脆弱人群提供颅骨保护。
