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氧化铜浸渍伤口敷料对未感染的糖尿病停滞伤口愈合的刺激作用。

Stimulation of Healing of Non-Infected Stagnated Diabetic Wounds by Copper Oxide-Impregnated Wound Dressings.

作者信息

Melamed Eyal, Rovitsky Alexei, Roth Tohar, Assa Lior, Borkow Gadi

机构信息

Department of Orthopaedics, Rambam Health Care Campus, Haifa 3109601, Israel.

MedCu Technologies Ltd., Herzliya 4672200, Israel.

出版信息

Medicina (Kaunas). 2021 Oct 19;57(10):1129. doi: 10.3390/medicina57101129.

Abstract

: Copper, a wide spectrum biocide, also plays a key role in angiogenesis and wound healing. Antibacterial wound dressings impregnated with copper oxide microparticles (COD) have been recently cleared by the U.S. FDA and other regulatory bodies for the treatment of acute and chronic wounds, including diabetic wounds. Our objective was to evaluate the capacity of COD in stimulating the healing of non-infected stagnated wounds in diabetic patients initially treated with standard of care (SOC) dressings. : The trial was divided into the three following phases: 1-2 weeks of screening, during which the patients were treated with SOC dressings; 4 weeks of treatment, during which the COD was applied twice weekly; and 2 weeks of follow-up, during which the patients were again treated with SOC dressings. The wound conditions and sizes were assessed by clinical evaluation and a wound imaging artificial intelligence system. : Following 1 month of COD treatment, there was a clear reduction in the mean wound area (53.2%; = 0.003), an increase in granulation tissue (43.37; < 0.001), and a reduction in fibrins (47.8%; = 0.002). In patients with non-weight-bearing wounds, the reduction in wound size was even more dramatic (66.9%; < 0.001). : The results of this study, showing a statistically significant influence of COD on wound healing of hard-to-heal wounds in diabetic patients, strongly supports the notion that copper oxide-impregnated dressings enhance wound healing directly. Further larger controlled studies should be conducted to substantiate our findings.

摘要

铜,一种广谱杀菌剂,在血管生成和伤口愈合中也起着关键作用。浸渍有氧化铜微粒(COD)的抗菌伤口敷料最近已获得美国食品药品监督管理局(FDA)和其他监管机构的批准,用于治疗急性和慢性伤口,包括糖尿病伤口。我们的目的是评估COD对最初接受标准护理(SOC)敷料治疗的糖尿病患者未感染的停滞伤口愈合的促进能力。

该试验分为以下三个阶段

1 - 2周的筛查期,在此期间患者使用SOC敷料进行治疗;4周的治疗期,在此期间每周两次应用COD;以及2周的随访期,在此期间患者再次使用SOC敷料进行治疗。通过临床评估和伤口成像人工智能系统评估伤口状况和大小。

在COD治疗1个月后,平均伤口面积明显减小(53.2%;P = 0.003),肉芽组织增加(43.37;P < 0.001),纤维蛋白减少(47.8%;P = 0.002)。在非负重伤口的患者中,伤口大小的减小更为显著(66.9%;P < 0.001)。

本研究结果表明COD对糖尿病患者难愈合伤口的愈合具有统计学上的显著影响,有力地支持了浸渍氧化铜的敷料直接促进伤口愈合的观点。应进行进一步更大规模的对照研究以证实我们的发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/545b/8538133/4f0b8a61d197/medicina-57-01129-g001.jpg

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