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庆大霉素盐水溶液与生理盐水在减少开放性阑尾切除术中手术部位感染的比较:一项随机对照试验

Comparison of Gentamicin Saline Solution and Normal Saline in Reducing Surgical Site Infections in Open Appendectomy: A Randomized Controlled Trial.

作者信息

Shrestha Bibek, Yadav Krishna Kumar, Buha Niravkumar Valjibhai, Dahal Suman, Yadav Pratibha, Yadav Prashant

机构信息

Maharajgunj Medical Campus Tribhuvan University, Institute of Medicine Nepal.

Department of General Surgery Tribhuvan University Teaching Hospital Nepal.

出版信息

Health Sci Rep. 2025 Aug 12;8(8):e71143. doi: 10.1002/hsr2.71143. eCollection 2025 Aug.

Abstract

BACKGROUND AND AIMS

Surgical site infections (SSIs) are a significant source of morbidity and healthcare costs following open appendectomy, particularly in resource-limited settings. While wound irrigation with antimicrobial agents has shown potential in reducing SSI rates, evidence comparing gentamicin-saline solution with normal saline is limited. This study aimed to determine whether gentamicin-saline irrigation reduces SSI rates compared to normal saline alone and to identify patient-related risk factors associated with SSI development.

METHODS

This single-centre, single-blinded, randomized controlled trial included 190 patients undergoing uncomplicated emergency open appendectomy between June 2022 and June 2023. Patients were randomly assigned to two groups: one receiving 160 mg gentamicin in 400 mL normal saline for wound irrigation, and the other receiving normal saline alone. The primary outcome was the incidence of SSI within 30 days. Secondary outcomes included length of hospital stay and association of SSI with risk factors such as BMI, smoking, and alcohol use. Statistical analysis was performed using SPSS v.26. Group differences were assessed using independent -tests and Fisher's exact or tests as appropriate. A value < 0.05 was considered statistically significant.

RESULTS

Among 190 patients (95 per group), the overall SSI rate was 15.3%, all of which were superficial. The gentamicin group had a lower SSI rate (12.6%) compared to the saline group (17.9%), but the difference was not statistically significant (= 0.313, RR 0.66; 95% CI, 0.298-1.478). Smoking was significantly associated with SSI occurrence (= 0.039), while BMI showed a significant association only in the gentamicin group (= 0.008). No association was observed with alcohol use.

CONCLUSION

SSIs contribute substantially to patient complications and healthcare expenses, particularly in lower-resource surgical settings. The reduction in SSI incidence using gentamicin-saline was not statistically significant when compared with normal saline as compared to gentamicin-saline irrigation did not significantly reduce SSIs compared to saline alone in uncomplicated open appendectomy. Focus should be placed on modifiable patient-related risk factors, particularly smoking, to reduce SSI incidence in clinical practice.

摘要

背景与目的

手术部位感染(SSIs)是开放性阑尾切除术后发病和医疗费用的重要来源,在资源有限的环境中尤为如此。虽然用抗菌剂冲洗伤口在降低手术部位感染率方面显示出潜力,但比较庆大霉素盐水溶液与生理盐水的证据有限。本研究旨在确定与单独使用生理盐水相比,庆大霉素盐水冲洗是否能降低手术部位感染率,并确定与手术部位感染发生相关的患者相关风险因素。

方法

这项单中心、单盲、随机对照试验纳入了2022年6月至2023年6月期间190例行非复杂性急诊开放性阑尾切除术的患者。患者被随机分为两组:一组接受含160mg庆大霉素的400mL生理盐水进行伤口冲洗,另一组仅接受生理盐水。主要结局是30天内手术部位感染的发生率。次要结局包括住院时间以及手术部位感染与体重指数、吸烟和饮酒等风险因素的相关性。使用SPSS v.26进行统计分析。使用独立样本t检验和Fisher精确检验或卡方检验(视情况而定)评估组间差异。P值<0.05被认为具有统计学意义。

结果

在190例患者(每组95例)中,总体手术部位感染率为15.3%,均为浅表感染。庆大霉素组的手术部位感染率(12.6%)低于生理盐水组(17.9%),但差异无统计学意义(P=0.313,RR 0.66;95%CI,0.298-1.478)。吸烟与手术部位感染的发生显著相关(P=0.039),而体重指数仅在庆大霉素组显示出显著相关性(P=0.008)。未观察到与饮酒的相关性。

结论

手术部位感染是患者并发症和医疗费用的重要原因,尤其是在资源较少的手术环境中。与生理盐水相比,庆大霉素盐水冲洗降低手术部位感染发生率的差异无统计学意义,即在非复杂性开放性阑尾切除术中,与单独使用生理盐水相比,庆大霉素盐水冲洗并不能显著降低手术部位感染率。在临床实践中,应关注可改变的患者相关风险因素,尤其是吸烟,以降低手术部位感染的发生率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/16c4/12343316/821f721538b3/HSR2-8-e71143-g003.jpg

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