Lancet. 2021 Nov 6;398(10312):1687-1699. doi: 10.1016/S0140-6736(21)01548-8. Epub 2021 Oct 25.
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.
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.
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.
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.
National Institute for Health Research (NIHR) Global Health Research Unit Grant, BD.
手术部位感染（SSI）是全球最常见的术后并发症。世界卫生组织（WHO）预防 SSI 的指南建议使用含酒精的氯己定皮肤准备和涂有三氯生的缝合线进行筋膜闭合，但呼吁在资源匮乏的环境中评估这两种干预措施。本研究旨在中低收入国家中测试这两种干预措施。
FALCON 是一项 2×2 析因随机对照试验，按手术是清洁污染、污染或污染进行分层，包括接受腹部手术且切口大于 5cm 的患者。该试验在 7 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。患者以 1:1:1:1 的比例随机分配至以下 4 组：（1）2%含酒精的氯己定和非涂层缝线，（2）2%含酒精的氯己定和涂有三氯生的缝线，（3）10%聚维酮碘水溶液和非涂层缝线，或（4）10%聚维酮碘水溶液和涂有三氯生的缝线。患者和结局评估者对干预措施的分配均不知情。主要结局是由经过培训的结局评估者报告的 SSI，并使用调整后的相对风险和 95%CI 呈现。分析采用意向治疗。本试验在 ClinicalTrials.gov 注册，编号为 NCT03700749。
2018 年 12 月 10 日至 2020 年 9 月 7 日，5788 名患者（清洁污染组 3091 名，污染或污染组 2697 名）被随机分配（1446 名接受含酒精的氯己定和非涂层缝线，1446 名接受含酒精的氯己定和涂有三氯生的缝线，1447 名接受 10%聚维酮碘水溶液和非涂层缝线，1449 名接受 10%聚维酮碘水溶液和涂有三氯生的缝线）。14.0%（810/5788）的患者为儿童，66.9%（3873/5788）的患者为急诊手术。总的 SSI 发生率为 22.0%（5284 名中的 1163 名；清洁污染组 15.5%[454/2923]，污染或污染组 30.0%[709/2361]）。对于两个亚组，用含酒精的氯己定与聚维酮碘相比，SSI 的风险均无差异（清洁污染组 15.3%[223/1455] vs 15.7%[231/1468]，相对风险 0.97[95%CI 0.82-1.14]；污染或污染组 28.3%[338/1194] vs 31.8%[371/1167]，相对风险 0.91[95%CI 0.81-1.02]），或用涂有三氯生的缝线与非涂层缝线相比，SSI 的风险也无差异（清洁污染组 14.7%[215/1459] vs 16.3%[239/1464]，相对风险 0.90[95%CI 0.77-1.06]；污染或污染组 29.4%[347/1181] vs 30.7%[362/1180]，相对风险 0.98[95%CI 0.87-1.10]）。将两个亚组合并，用含酒精的氯己定或涂有三氯生的缝线均无差异。
本试验并未显示在清洁污染或污染或污染的手术伤口中，与聚维酮碘相比，使用 2%含酒精的氯己定皮肤准备或与非涂层缝线相比，使用涂有三氯生的缝线预防 SSI 具有优势。这两种干预措施都比替代品更昂贵，这些发现不支持常规使用的建议。
英国国家卫生研究院（NIHR）全球卫生研究单位资助，BD。
