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一项评价含银藻酸盐粉末的抗菌敷料用于管理表现出临界定植迹象的慢性伤口的随机对照试验。

A randomized controlled trial to evaluate an antimicrobial dressing with silver alginate powder for the management of chronic wounds exhibiting signs of critical colonization.

机构信息

School of Nursing, Queen's University, Kingston, and Wound Care Consultant, West Park Health Centre, Toronto, Ontario, Canada.

出版信息

Adv Skin Wound Care. 2012 Nov;25(11):503-8. doi: 10.1097/01.ASW.0000422628.63148.4b.

Abstract

OBJECTIVE

The primary objective of this study was to evaluate if a topical silver dressing that consists of silver alginate powder is effective in managing chronic wounds that exhibit signs of critical colonization and promoting wound healing.

METHOD

This was a prospective, open-label, 4-week randomized controlled trial. The primary end points of the study were changes in signs associated with critical colonization and in wound surface areas. All subjects were evaluated at weeks 0, 2, and 4 at the end of the study. SUBJECT AND SETTINGS: Participants between 18 and 85 years of age were recruited from 2 wound care clinics in Canada. The study was reviewed and approved by research ethics boards.

DATA ANALYSIS

Analyses of this study were carried out based on intent-to-treat principle; t tests were used to determine if the means were statistically different between treatment groups.

RESULTS

Thirty-four subjects participated and completed in the study. In the control group, the mean infection checklist score was 2.2 at baseline and 2.3 at week 4 (t9 = -0.36, P = .73). In the silver alginate powder group, the infection score reduced from 3.3 at baseline to 1.3 at week 4; the result was significant (t23 = 7.62, P < .00). The difference in average surface reduction over time between the 2 groups was statistically significant (t32 = 3.56, P < .001). Subjects randomized to the silver group achieved a greater surface reduction than those who were randomized to the use of foam dressing as the control.

CONCLUSION

Silver alginate powder is an effective treatment option for wounds with increased bacterial burden.

摘要

目的

本研究的主要目的是评估一种由银藻酸钠粉末组成的局部银敷料是否能有效治疗表现出临界定植迹象的慢性伤口,并促进伤口愈合。

方法

这是一项前瞻性、开放性、4 周随机对照试验。该研究的主要终点是与临界定植相关的体征和伤口表面积的变化。所有受试者在研究结束时的第 0、2 和 4 周进行评估。

受试者和设置

本研究招募了来自加拿大 2 家伤口护理诊所的 18 至 85 岁的受试者。研究经伦理审查委员会审查和批准。

数据分析

该研究的分析基于意向治疗原则进行;采用 t 检验确定治疗组之间的平均值是否存在统计学差异。

结果

34 名受试者参与并完成了该研究。在对照组中,感染检查表的平均评分在基线时为 2.2,在第 4 周时为 2.3(t9=-0.36,P=.73)。在银藻酸钠粉末组中,感染评分从基线时的 3.3 降至第 4 周时的 1.3,结果具有统计学意义(t23=7.62,P<.00)。两组间平均表面积随时间的减少差异具有统计学意义(t32=3.56,P<.001)。随机分配到银组的受试者比随机分配到使用泡沫敷料作为对照组的受试者实现了更大的表面积减少。

结论

银藻酸钠粉末是治疗细菌负荷增加的伤口的有效治疗选择。

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