Abstract

Cold atmospheric plasma (CAP) devices generate an ionized gas with highly reactive species and electric fields at ambient air pressure and temperature. A flexible dielectric barrier discharge (DBD) was developed as an alternative antimicrobial treatment for chronic wounds. Treatment of Staphylococcus aureus in collagen-elastin matrices with CAP for 2 min resulted in a 4 log reduction. CAP treatment was less effective on S. aureus on dermal samples. CAP did not affect cellular activity or DNA integrity of human dermal samples when used for up to 2 min. Repeated daily CAP treatments for 2 min lowered cellular activity of dermal samples to 80% after 2 to 4 days, but this was not significant. Repeated treatment of ex vivo human burn wound models with CAP for 2 min did not affect re-epithelialization. Intact skin of 25 healthy volunteers was treated with CAP for 3× 20” to determine safety. Although participants reported moderate pain scores (numerical rating scale 3.3), all volunteers considered the procedure to be acceptable. Severe adverse events did not occur. CAP treatment resulted in a temporarily increased local skin temperature (≈3.4°C) and increased erythema. Lowering the plasma power resulted in a significantly lower erythema increase. Good log reduction (2.9) of bacterial load was reached in 14/15 volunteers artificially contaminated with Pseudomonas aeruginosa. This study demonstrated the in vitro and in vivo safety and efficacy in bacterial reduction of a flexible cold plasma device. Trial registration number NCT03007264, January 2, 2017

Key Points

• CAP strongly reduced bacterial numbers both in vitro and in vivo.

• Re-epithelialization of burn wound models was not affected by repeated CAP.

• CAP treatment of intact skin was well tolerated in volunteers.

中文翻译：

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用于刺激伤口愈合的柔性冷大气等离子体装置的抗菌和安全性测试

摘要

冷大气等离子体 (CAP) 设备在环境气压和温度下产生具有高反应性物质和电场的电离气体。开发了一种柔性电介质阻挡放电 (DBD) 作为慢性伤口的替代抗菌治疗方法。用 CAP处理胶原蛋白-弹性蛋白基质中的金黄色葡萄球菌2 分钟导致 4 log 减少。CAP 治疗对金黄色葡萄球菌效果较差在皮肤样本上。当使用长达 2 分钟时，CAP 不会影响人类皮肤样本的细胞活性或 DNA 完整性。每天重复 2 分钟的 CAP 治疗在 2 至 4 天后将皮肤样本的细胞活性降低到 80%，但这并不显着。用 CAP 重复处理离体人类烧伤创面模型 2 分钟不影响上皮再形成。用 CAP 对 25 名健康志愿者的完整皮肤进行 3×20" 处理以确定安全性。尽管参与者报告了中度疼痛评分（数字评分量表 3.3），但所有志愿者都认为该程序是可以接受的。没有发生严重的不良事件。CAP 治疗导致局部皮肤温度暂时升高（≈3.4°C）和红斑增加。降低等离子功率导致红斑增加显着降低。良好的对数减少 (2.铜绿假单胞菌。该研究证明了柔性冷等离子体装置在体外和体内减少细菌的安全性和有效性。试用注册号NCT03007264，2017年1月2日

关键点

• CAP 大大减少了体外和体内的细菌数量。

• 烧伤模型的上皮再形成不受重复 CAP 的影响。

• 志愿者对完整皮肤的 CAP 治疗具有良好的耐受性。