United States Army Institute of Surgical Research, Ft. Sam Houston, Texas, USA.
Comprehensive Wound Center, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Adv Wound Care (New Rochelle). 2024 Jan;13(1):1-13. doi: 10.1089/wound.2023.0007. Epub 2023 Apr 11.
Despite advances in the use of topical and parenteral antimicrobial therapy and the practice of early tangential burn wound excision to manage bacterial load, 60% of the mortality from burns is attributed to bacterial biofilm infection. A low electric field (∼1 V) generated by the novel FDA-cleared wireless electroceutical dressing (WED) was previously shown to significantly prevent and disrupt burn biofilm infection in preclinical studies. Based on this observation, the purpose of this clinical trial was to evaluate the efficacy of the WED dressing powered by a silver-zinc electrocouple in the prevention and disruption of biofilm infection. : A prospective, randomized, controlled, single-center clinical trial was performed to evaluate the efficacy of the WED compared with standard-of-care (SoC) dressing to treat biofilms. Burn wounds were randomized to receive either SoC or WED. Biopsies were collected on days 0 and 7 for histology, scanning electron microscopy (SEM) examination of biofilm, and for quantitative bacteriological analyses. In total, 38 subjects were enrolled in the study. In 52% of the WED-treated wounds, little to no biofilm could be detected by SEM. WED significantly lowered or prevented increase of biofilm in all wounds compared with the pair-matched SoC-treated wounds. WED is a simple, easy, and rapid method to protect the wound while also inhibiting infection. It is activated by a moist environment and the electrical field induces transient and micromolar amounts of superoxide anion radicals that will prevent bacterial growth. WED decreased biofilm infection better compared with SoC. The study was registered in clinicaltrials.gov as NCT04079998.
尽管在局部和全身使用抗菌治疗以及早期进行切线性烧伤创面切除以减少细菌负荷方面取得了进展，但烧伤死亡率的 60%仍归因于细菌生物膜感染。先前的研究表明，新型 FDA 批准的无线电疗敷贴（WED）产生的低电场（约 1V）可显著预防和破坏烧伤生物膜感染。基于这一观察结果，本临床试验旨在评估由银锌电偶供能的 WED 敷料在预防和破坏生物膜感染方面的疗效。 ：一项前瞻性、随机、对照、单中心临床试验旨在评估 WED 与标准护理（SoC）敷料治疗生物膜的疗效。烧伤创面随机接受 SoC 或 WED 治疗。在第 0 天和第 7 天采集活检标本进行组织学检查、生物膜扫描电子显微镜（SEM）检查和定量细菌学分析。 共有 38 名受试者入组该研究。在 52%的 WED 治疗的创面中，SEM 几乎检测不到生物膜。与配对的 SoC 治疗创面相比，WED 可显著降低或预防所有创面生物膜的增加。 WED 是一种简单、易用且快速的保护创面同时抑制感染的方法。它由潮湿的环境激活，电场诱导瞬态和毫摩尔浓度的超氧阴离子自由基，从而阻止细菌生长。 与 SoC 相比，WED 可更好地减少生物膜感染。该研究在 clinicaltrials.gov 上注册为 NCT04079998。
