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局部使用庆大霉素预防择期切口疝修补术手术部位感染的随机对照试验。

Effect of topical gentamicin in preventing surgical site infection in elective incisional hernia repair in a randomized controlled trial.

机构信息

Department of General and Digestive Surgery, Hospital Clínic Barcelona, Barcelona, 08036, Spain.

Department of Surgery, Hospital del Mar, Barcelona, 08003, Spain.

出版信息

Sci Rep. 2024 Nov 20;14(1):28755. doi: 10.1038/s41598-024-80112-y.

Abstract

Surgical site infection (SSI) continues to be a common complication of surgery. The real benefit of using topical antibiotics for the prevention of SSI in abdominal hernia repair surgery is still unknown. This study aimed to evaluate the usefulness of topical gentamicin in SSI prophylaxis in incisional hernia repair with mesh. A randomized controlled trial was conducted in patients undergoing open incisional hernia repair. Patients were randomly assigned to one of two groups: in the gentamicin group, each layer of the abdominal wall was irrigated with gentamicin solution before wound closure, and in the saline solution group (placebo), each layer of the abdominal wall was irrigated with normal saline solution. The incidence of SSI and other surgical site complications was compared between both groups, and the presence of adverse effects with the use of topical gentamicin. Data from 146 patients were included for analysis: 74 in the gentamicin group and 72 in the saline solution group. SSI was observed in six patients (8.1%) in the gentamicin group and eight patients (11.1%) in the saline solution group, with no significant differences (p = 0.538) between both groups. No statistically significant differences were observed in the presentation of seroma, hematoma, and surgical wound dehiscence between both groups. No adverse effects were reported from topical application of gentamicin. In this clinical trial, the use of topical gentamicin in incisional hernia repair with mesh did not significantly reduce the incidence of SSI. EU Clinical Trials Register: EudraCT 2018-001860-45 (04/07/2019).

摘要

手术部位感染 (SSI) 仍然是手术的常见并发症。在腹部疝修补术中使用局部抗生素预防 SSI 的真正益处尚不清楚。本研究旨在评估局部庆大霉素在网片修补切口疝中预防 SSI 的有用性。一项随机对照试验在接受开放性切口疝修补术的患者中进行。患者被随机分配到两组中的一组:在庆大霉素组中,在关闭伤口之前,用庆大霉素溶液冲洗腹壁的每一层,在生理盐水组(安慰剂)中,用生理盐水溶液冲洗腹壁的每一层。比较两组之间 SSI 和其他手术部位并发症的发生率,并观察使用局部庆大霉素的不良反应。纳入了 146 例患者的数据进行分析:庆大霉素组 74 例,生理盐水组 72 例。庆大霉素组中有 6 例(8.1%)发生 SSI,生理盐水组中有 8 例(11.1%)发生 SSI,两组之间无显著差异(p=0.538)。两组之间血清肿、血肿和手术切口裂开的发生率无统计学差异。局部应用庆大霉素未报告不良反应。在这项临床试验中,在网片修补切口疝中使用局部庆大霉素并没有显著降低 SSI 的发生率。欧盟临床试验注册中心:EudraCT 2018-001860-45(2019 年 7 月 4 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3108/11579354/0bf3f9e0ed64/41598_2024_80112_Fig1_HTML.jpg

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