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定制带压力传感器的 3D 压缩面罩对面部烧伤瘢痕的作用:一项单盲、随机对照试验。

Utility of customized 3D compression mask with pressure sensors on facial burn scars: A single-blinded, randomized controlled trial.

机构信息

COMWEL Korea Orthopedics & Rehabilitation Engineering Center, Korea Workers' Compensation and Welfare Service, Incheon 21417, Republic of Korea.

Department of Rehabilitation Medicine, Burn Institute, Hangang Sacred Heart Hospital, Hallym University College of Medicine, Seoul 07247, Republic of Korea.

出版信息

Burns. 2024 Sep;50(7):1885-1897. doi: 10.1016/j.burns.2024.05.021. Epub 2024 Jun 6.

DOI:10.1016/j.burns.2024.05.021
PMID:38937166
Abstract

PURPOSE

A pressure of approximately 15-25 mmHg is used for effective compression therapy to prevent and treat hypertrophic scar formation in patients with burns. However, conventional facial compression garments present challenges owing to inadequate pressure distribution in curved areas such as the cheeks, around the mouth, and the slope of the nose. This study aimed to evaluate the utility of a custom-made 3D compression mask equipped with pressure sensors to treat facial burn scars.

METHODS

This single-blinded, prospective randomized controlled trial was conducted between May and October 2023, involving 48 burn scars in 12 inpatients with facial burns. We created the custom-made 3D compression mask equipped with pressure sensors, inner lined with biocompatible silicon, and a harness system using 3D printing technology, which can continuously monitor whether an appropriate pressure of 15-25 mmHg maintains. The biological scar properties, Vancouver Scar Scale (VSS), and Patient and Observer Scar Assessment Scale (POSAS) scores in patients with facial burns were assessed before applying the compression mask and garment and at 4 and 12 weeks after application.

RESULTS

Pre-application assessment of biological scar properties, VSS, and POSAS revealed no statistically significant differences between the 3D mask and control groups (p > 0.05 for all). Throughout the 12-week application, skin hydration and scar thickness significantly increased (p < 0.001) and reduced (p = 0.010), respectively, in the 3D mask group compared to the control group. Additionally, significant improvements in scar pliability (p = 0.004) and height (p = 0.009) of VSS, itching (p = 0.047), scar stiffness (p = 0.001), thickness (p = 0.011), and irregularity (p < 0.001) of POSAS-patient component, and scar thickness (p = 0.001), pliability (p = 0.012), and surface area (p = 0.027) of the POSAS-observer component were observed in 3D mask group throughout the 12-week application compared to the control group.

CONCLUSION

The customized 3D compression mask equipped with pressure sensors significantly improved scar thickness, skin hydration, and various assessment scale parameters throughout the 12-week application.

摘要

目的

为了预防和治疗烧伤患者增生性瘢痕的形成,使用约 15-25mmHg 的压力进行有效加压治疗。然而,传统的面部加压服在面部的弯曲区域(如脸颊、口周和鼻梁)存在压力分布不足的问题。本研究旨在评估一种配备压力传感器的定制 3D 压缩面罩在治疗面部烧伤瘢痕方面的效用。

方法

这是一项于 2023 年 5 月至 10 月进行的、单盲、前瞻性随机对照试验,共纳入 12 例面部烧伤住院患者的 48 处烧伤瘢痕。我们使用 3D 打印技术制作了配备压力传感器的定制 3D 压缩面罩,内表面衬有生物相容性硅,并配备了一个吊带系统,可以持续监测是否保持 15-25mmHg 的适当压力。在使用压缩面罩和加压服之前以及使用后 4 周和 12 周,评估面部烧伤患者的生物瘢痕性质、温哥华瘢痕量表(VSS)和患者和观察者瘢痕评估量表(POSAS)评分。

结果

在使用 3D 面罩和对照组之前,对生物瘢痕性质、VSS 和 POSAS 进行了预评估,结果显示两组之间没有统计学差异(p>0.05)。在整个 12 周的应用过程中,与对照组相比,3D 面罩组的皮肤水分和瘢痕厚度均显著增加(p<0.001)和减少(p=0.010)。此外,VSS 的瘢痕柔韧性(p=0.004)和高度(p=0.009)、瘙痒(p=0.047)、瘢痕硬度(p=0.001)、厚度(p=0.011)和不规则性(p<0.001)以及 POSAS-患者成分的瘢痕厚度(p=0.001)、柔韧性(p=0.012)和表面积(p=0.027)均显著改善。与对照组相比,3D 面罩组在整个 12 周的应用过程中均有改善。

结论

配备压力传感器的定制 3D 压缩面罩在整个 12 周的应用过程中,显著改善了瘢痕厚度、皮肤水分和各种评估量表参数。

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