Background

Surgical site infection (SSI) is the most common postoperative complication worldwide. WHO guidelines to prevent SSI recommend alcoholic chlorhexidine skin preparation and fascial closure using triclosan-coated sutures, but called for assessment of both interventions in low-resource settings. This study aimed to test both interventions in low-income and middle-income countries.

Methods

FALCON was a 2 × 2 factorial, randomised controlled trial stratified by whether surgery was clean-contaminated, or contaminated or dirty, including patients undergoing abdominal surgery with a skin incision of 5 cm or greater. This trial was undertaken in 54 hospitals in seven countries (Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa). Patients were computer randomised 1:1:1:1 to: (1) 2% alcoholic chlorhexidine and non-coated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone–iodine and non-coated suture, or (4) 10% aqueous povidone–iodine and triclosan-coated suture. Patients and outcome assessors were masked to intervention allocation. The primary outcome was SSI, reported by trained outcome assessors, and presented using adjusted relative risks and 95% CIs. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03700749.

Findings

Between Dec 10, 2018, and Sept 7, 2020, 5788 patients (3091 in clean-contaminated stratum, 2697 in contaminated or dirty stratum) were randomised (1446 to alcoholic chlorhexidine and non-coated suture, 1446 to alcoholic chlorhexidine and triclosan-coated suture, 1447 to aqueous povidone–iodine and non-coated suture, and 1449 to aqueous povidone–iodine and triclosan-coated suture). 14·0% (810/5788) of patients were children and 66·9% (3873/5788) had emergency surgery. The overall SSI rate was 22·0% (1163/5284; clean-contaminated stratum 15·5% [454/2923], contaminated or dirty stratum 30·0% [709/2361]). For both strata, there was no evidence of a difference in the risk of SSI with alcoholic chlorhexidine versus povidone–iodine (clean-contaminated stratum 15·3% [223/1455] vs 15·7% [231/1468], relative risk 0·97 [95% CI 0·82–1·14]; contaminated or dirty stratum 28·3% [338/1194] vs 31·8% [371/1167], relative risk 0·91 [95% CI 0·81–1·02]), or with triclosan-coated sutures versus non-coated sutures (clean-contaminated stratum 14·7% [215/1459] vs 16·3% [239/1464], relative risk 0·90 [95% CI 0·77–1·06]; contaminated or dirty stratum 29·4% [347/1181] vs 30·7% [362/1180], relative risk 0·98 [95% CI 0·87–1·10]). With both strata combined, there were no differences using alcoholic chlorhexidine or triclosan-coated sutures.

Interpretation

This trial did not show benefit from 2% alcoholic chlorhexidine skin preparation compared with povidone–iodine, or with triclosan-coated sutures compared with non-coated sutures, in preventing SSI in clean-contaminated or contaminated or dirty surgical wounds. Both interventions are more expensive than alternatives, and these findings do not support recommendations for routine use.

Funding

National Institute for Health Research (NIHR) Global Health Research Unit Grant, BD.

中文翻译：

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减少低收入和中等收入国家的手术部位感染 (FALCON)：一项实用的、多中心的、分层的、随机对照试验

背景

手术部位感染（SSI）是世界范围内最常见的术后并发症。WHO 预防 SSI 的指南推荐酒精洗必泰备皮和使用三氯生涂层缝线缝合筋膜，但呼吁在资源匮乏的环境中评估这两种干预措施。本研究旨在测试低收入和中等收入国家的干预措施。

方法

FALCON 是一项 2 × 2 析因随机对照试验，根据手术是干净污染、污染还是肮脏进行分层，包括接受腹部手术且皮肤切口 5 厘米或更大的患者。该试验在七个国家（贝宁、加纳、印度、墨西哥、尼日利亚、卢旺达和南非）的 54 家医院进行。患者按 1:1:1:1 计算机随机分配至：(1) 2% 酒精洗必泰和无涂层缝合线，(2) 2% 酒精洗必泰和三氯生涂层缝合线，(3) 10% 聚维酮碘水溶液和非- 涂层缝合线，或 (4) 10% 聚维酮碘水溶液和三氯生涂层缝合线。患者和结果评估者对干预分配设盲。主要结果是 SSI，由训练有素的结果评估员报告，并使用调整后的相对风险和 95% CI 呈现。分析是通过意向治疗。该试验已在 ClinicalTrials.gov 注册，NCT03700749。

发现

2018 年 12 月 10 日至 2020 年 9 月 7 日期间，5788 名患者（清洁污染层 3091 名，污染或污染层 2697 名）被随机分配（1446 名接受酒精洗必泰和无涂层缝合线，1446 名接受酒精洗必泰和三氯生涂层缝线）缝线，1447 到聚维酮碘水溶液和无涂层缝线，1449 到聚维酮碘水溶液和三氯生涂层缝线）。14·0% (810/5788) 的患者是儿童，66·9% (3873/5788) 进行了急诊手术。总体 SSI 率为 22·0%（1163/5284；干净-污染层 15·5% [454/2923]，污染或脏层 30·0% [709/2361]）。对于两个阶层，没有证据表明酒精洗必泰与聚维酮碘的 SSI 风险存在差异（清洁污染阶层 15·3% [223/1455] vs15·7% [231/1468]，相对风险 0·97 [95% CI 0·82–1·14]；污染或脏层 28·3% [338/1194]与31·8% [371/1167]，相对风险 0·91 [95% CI 0·81–1·02]），或使用三氯生涂层缝线与非涂层缝合线（清洁污染层 14·7% [215/1459] vs 16·3% [239/1464]，相对风险 0·90 [95% CI 0·77–1·06]；污染或脏层 29·4% [347/1181]对比30·7% [362/1180]，相对风险 0·98 [95% CI 0·87–1·10]）。结合这两个层次，使用酒精洗必泰或三氯生涂层缝合线没有差异。

解释

该试验未显示 2% 酒精洗必泰皮肤准备与聚维酮碘相比，或与非涂层缝线相比，三氯生涂层缝线在预防清洁污染或污染或肮脏的手术伤口中的 SSI 方面的益处。这两种干预措施都比替代方法更昂贵，这些发现不支持常规使用的建议。

资金

美国国立卫生研究院 (NIHR) 全球健康研究单位资助，BD。