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含铜伤口敷料对剖宫产术后手术部位感染的影响:一项双盲随机对照研究。

The impact of copper impregnated wound dressings on surgical site infection following caesarean section: a double blind randomised controlled study.

作者信息

Arendsen Linda P, Thakar R, Bassett P, Sultan A H

机构信息

Research Fellow, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom.

Consultant Obstetrician and Urogynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2020 Aug;251:83-88. doi: 10.1016/j.ejogrb.2020.05.016. Epub 2020 May 20.

Abstract

OBJECTIVE

To investigate the effect of copper impregnated wound dressings on the surgical site infection (SSI) rate following caesarean section (CS).

DESIGN

Single centre double blind randomised controlled trial.

PARTICIPANTS

Women aged 18 years or over who had a CS.

INTERVENTIONS

All women were randomised to receive either a copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group).

MAIN OUTCOME MEASURES

The primary study outcome was the incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire. Secondary outcomes were length of hospital stay, and readmission rate.

RESULTS

324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group. The follow up rate was 97.5%. A total of 78 women (24.1%) developed an SSI within 30 days following CS; 29 (18.2%) in the study group and 49 (29.7%) controls (P = 0.037, relative risk reduction (RRR) of 38.7%). The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002). Length of hospital stay, and readmission rate did not vary significantly between groups.

CONCLUSIONS

This is the first study to demonstrate a significant reduction in SSI rates following CS with the use of copper impregnated wound dressings. The high SSI rate confirms the importance of new strategies to reduce the infection rate. Copper is a natural remedy which could potentially reduce hospital acquired infections without the use of antibiotics and its associated risks of antibiotic resistance.

摘要

目的

探讨含铜伤口敷料对剖宫产术后手术部位感染(SSI)发生率的影响。

设计

单中心双盲随机对照试验。

参与者

年龄在18岁及以上的剖宫产女性。

干预措施

所有女性被随机分为接受氧化铜浸渍伤口敷料(研究组)或不含铜伤口敷料(对照组)。

主要观察指标

主要研究结局是剖宫产术后30天内SSI的发生率,通过电话问卷调查进行评估。次要结局是住院时间和再入院率。

结果

324名女性参与了该研究,其中159名被随机分配到研究组,165名被分配到对照组。随访率为97.5%。共有78名女性(24.1%)在剖宫产术后30天内发生了SSI;研究组中有29名(18.2%),对照组中有49名(29.7%)(P = 0.037,相对风险降低率(RRR)为38.7%)。浅表/深部SSI的发生率无显著差异(24.2%对17.6%,P = 0.257),然而,研究组中器官/腔隙SSI的相对风险显著降低了80.3%(12.7%对2.5%,P = 0.002)。两组之间的住院时间和再入院率没有显著差异。

结论

这是第一项证明使用含铜伤口敷料可显著降低剖宫产术后SSI发生率的研究。高SSI发生率证实了采用新策略降低感染率的重要性。铜是一种天然疗法,有可能在不使用抗生素及其相关耐药风险的情况下减少医院获得性感染。

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