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局部应用庆大霉素治疗深部胸骨伤口感染:一项随机对照试验。

Application of local gentamicin in the treatment of deep sternal wound infection: a randomized controlled trial.

作者信息

Vos Roemer J, van Putte Bart P, de Mol Bas A J M, Hoogewerf Marieke, Mandigers Tim J, Kloppenburg Geoffrey T L

机构信息

Department of Cardiothoracic Surgery, St. Antonius Hospital, Nieuwegein, Netherlands.

Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Amsterdam, Netherlands.

出版信息

Eur J Cardiothorac Surg. 2022 May 2;61(5):1135-1141. doi: 10.1093/ejcts/ezab479.

DOI:10.1093/ejcts/ezab479
PMID:34849690
Abstract

OBJECTIVES

In patients with deep sternal wound infection (DSWI), primary closure of the sternal bone over high negative pressure Redon drains has shown to be a safe and feasible treatment method. Addition of local gentamicin could accelerate healing and improve clinical outcomes.

METHODS

We conducted a randomized controlled trial to evaluate the effectiveness of local gentamicin in the treatment of DSWI. In the treatment group, collagenous carriers containing gentamicin were left between the sternal halves during sternal refixation. In the control group, no local antibiotics were used. Primary outcome was hospital stay. Secondary outcomes were mortality, reoperation, wound sterilization time, time till removal of all drains and duration of intravenous antibiotic treatment.

RESULTS

Forty-one patients were included in the trial of which 20 were allocated to the treatment group. Baseline characteristics were similar in both groups. Drains could be removed after a median of 8.5 days in the treatment group and 14.5 days in the control group (P-value: 0.343). Intravenous antibiotics were administered for a median of 23.5 days in the treatment group and 38.5 days in the control group (P-value: 0.343). The median hospital stay was 27 days in the treatment group and 28 days in the control group (P-value: 0.873). Mortality rate was 10% in the treatment group and 9.5% in the control group (P-value: 0,959). No side effects were observed.

CONCLUSIONS

This randomized controlled trial showed that addition of local gentamicin in the treatment of DSWI did not result in shorter length of stay.

CLINICAL TRIAL REGISTRATION NUMBER

2014-001170-33.

摘要

目的

在患有深部胸骨伤口感染(DSWI)的患者中,在高负压雷东引流管上方对胸骨进行一期缝合已被证明是一种安全可行的治疗方法。添加局部庆大霉素可加速愈合并改善临床结果。

方法

我们进行了一项随机对照试验,以评估局部庆大霉素治疗DSWI的有效性。在治疗组中,胸骨重新固定期间在胸骨两半之间留置含庆大霉素的胶原载体。在对照组中,未使用局部抗生素。主要结局是住院时间。次要结局是死亡率、再次手术、伤口灭菌时间、所有引流管拔除时间和静脉抗生素治疗持续时间。

结果

41例患者纳入试验,其中20例被分配到治疗组。两组的基线特征相似。治疗组中位8.5天可拔除引流管,对照组为14.5天(P值:0.343)。治疗组静脉抗生素中位使用23.5天,对照组为38.5天(P值:0.343)。治疗组中位住院时间为27天,对照组为28天(P值:0.873)。治疗组死亡率为10%,对照组为9.5%(P值:0.959)。未观察到副作用。

结论

这项随机对照试验表明,在DSWI治疗中添加局部庆大霉素并不会缩短住院时间。

临床试验注册号

2014 - 001170 - 33。

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