RESUMEN
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.