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透明质酸与金属银治疗慢性伤口:愈合率与细菌载量控制

Hyaluronic acid and metallic silver treatment of chronic wounds: healing rate and bacterial load control.

作者信息

Gazzabin Luca, Serantoni Simone, Palumbo Francesco Paolo, Giordan Nicola

机构信息

General Surgery Unit, Wound Care and Diabetic Foot Surgery Unit, Villa Fiorita Private Clinic, Prato, Italy.

Fidia Farmaceutici S.p.A, Abano, Italy.

出版信息

J Wound Care. 2019 Jul 2;28(7):482-490. doi: 10.12968/jowc.2019.28.7.482.

Abstract

OBJECTIVE

To confirm the safety and wound healing activity of a topical spray powder containing hyaluronic acid (HA) and metallic silver (Hyalosilver, Fidia Farmaceutici S.p.A., Italy), and investigate its effect on the control of bacterial load in vascular ulcers or category I-II pressure ulcers (PU).

METHODS

This is a single site, prospective, open label study involving patients with a vascular ulcer or category I-II PUs, presenting signs of critical bacterial colonisation. Patients with a wound size of ≤15cm were enrolled. At baseline, a swab was taken of each wound for a semi-quantitative analysis of bacterial load and the first treatment of topical spray powder was applied. The patient was then requested to self-apply the medication once a day for 28 consecutive days and to return on days one, seven and 28 for clinical and microbiological assessments.

RESULTS

A total of 25 patients were enrolled in the study. Treatment with the topical spray powder enhanced the healing rate of chronic wounds in terms of a reduction of wound area as well as bacterial load (p<0.025) and the overall clinical status of wound (odour, exudate, erythema of periwound skin; p<0.017). Moreover, the spray powder increased overall patient perception of improvement in the wound (p<0.05).

CONCLUSION

The data demonstrated good safety and tolerability of the topical spray powder suggesting that the product is effective not only in reducing wound area, due to the presence of HA, but in keeping the bacterial colonisation under control.

摘要

目的

确认一种含有透明质酸(HA)和金属银(Hyalosilver,意大利菲迪亚制药公司)的外用喷雾粉剂的安全性和伤口愈合活性,并研究其对血管性溃疡或I-II期压疮(PU)细菌负荷控制的效果。

方法

这是一项单中心、前瞻性、开放标签研究,纳入患有血管性溃疡或I-II期PU且有严重细菌定植迹象的患者。纳入伤口大小≤15cm的患者。在基线时,从每个伤口采集拭子进行细菌负荷的半定量分析,并应用首次外用喷雾粉剂治疗。然后要求患者连续28天每天自行用药一次,并在第1、7和28天返回进行临床和微生物学评估。

结果

共有25名患者纳入该研究。外用喷雾粉剂治疗提高了慢性伤口的愈合率,表现为伤口面积以及细菌负荷的减少(p<0.025)和伤口的整体临床状况(气味、渗出物、伤口周围皮肤红斑;p<0.017)。此外,喷雾粉剂提高了患者对伤口改善的总体感知(p<0.05)。

结论

数据表明外用喷雾粉剂具有良好的安全性和耐受性,这表明该产品不仅由于HA的存在而有效减少伤口面积,而且能控制细菌定植。

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