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稳定次氯酸在醋酸缓冲液中用于治疗急性伤口的安全性和抗菌性能:一项人体初步研究和体外数据。

The Safety and Antimicrobial Properties of Stabilized Hypochlorous Acid in Acetic Acid Buffer for the Treatment of Acute Wounds-a Human Pilot Study and In Vitro Data.

机构信息

Department of Dermato-Venereology & Wound Healing Center, Bispebjerg Hospital, Copenhagen, Denmark.

Devicia AB, Mölndal, Sweden.

出版信息

Int J Low Extrem Wounds. 2023 Jun;22(2):369-377. doi: 10.1177/15347346211015656. Epub 2021 May 5.

Abstract

Acute wounds may require cleansing to reduce the risk of infection. Stabilized hypochlorous acid in acetic buffer (HOCl + buffer) is a novel wound irrigation solution with antimicrobial properties. We performed a first-in-man, prospective, open-label pilot study to document preliminary safety and performance in the treatment of acute wounds. The study enrolled 12 subjects scheduled for a split-skin graft transplantation, where the donor site was used as a model of an acute wound. The treatment time was 75 s, given on 6 occasions. A total of 7 adverse events were regarded as related to the treatment; all registered as pain during the procedure for 2 subjects. One subject had a wound infection at the donor site. The mean colony-forming unit (CFU) decreased by 41% after the treatment, and the mean epithelialization was 96% on both days 14 (standard deviation [SD] 8%) and 21 (SD 10%). The study provides preliminary support for the safety, well-tolerance, and efficacy of HOCl + buffer for acute wounds. The pain was frequent although resolved quickly. Excellent wound healing and satisfying antimicrobial properties were observed. A subsequent in vitro biofilm study also indicated good antimicrobial activity against with a 96% mean reduction of CFU, when used for a treatment duration of 15 min ( < .0001), and a 50% decrease for ( = .1010). Future larger studies are needed to evaluate the safety and performance of HOCl + buffer in acute wounds, including the promising antimicrobial effect by prolonged treatment on bacterial biofilms.

摘要

急性伤口可能需要清洗以降低感染风险。稳定的次氯酸(HOCl)+缓冲液在乙酸缓冲液中是一种具有抗菌特性的新型伤口冲洗液。我们进行了首例人体、前瞻性、开放性试验研究,以记录在治疗急性伤口方面的初步安全性和疗效。该研究纳入了 12 名计划进行皮肤切开移植的受试者,供体部位用作急性伤口模型。治疗时间为 75 秒,共进行 6 次。共有 7 例不良事件被认为与治疗有关;所有 2 例受试者均在手术过程中出现疼痛。1 例供体部位发生伤口感染。治疗后,平均菌落形成单位(CFU)减少 41%,第 14 天(标准差 8%)和第 21 天(标准差 10%)的平均上皮化率均为 96%。该研究初步支持 HOCl + 缓冲液用于急性伤口的安全性、良好耐受性和疗效。疼痛虽然很快缓解,但较为频繁。观察到良好的伤口愈合和令人满意的抗菌性能。随后的体外生物膜研究也表明,当使用 15 分钟(<0.0001)的治疗时间时,HOCl + 缓冲液对具有 96%的平均 CFU 减少,当用于治疗时间为 15 分钟时,对具有 50%的减少(=0.1010)。需要进一步进行更大规模的研究,以评估 HOCl + 缓冲液在急性伤口中的安全性和疗效,包括延长治疗对细菌生物膜的潜在抗菌作用。

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