小柯机器人

NIHR全球研究健康部国际外科为减少中低收入国家手术部位感染进行了一项析因随机试验。相关论文于2021年10月26日发表在《柳叶刀》杂志上。

手术部位感染（SSI）是世界范围内最常见的术后并发症。世卫组织预防SSI指南建议使用酒精洗必泰备皮，使用三氯生涂层缝线进行筋膜闭合，但呼吁在医疗资源不足的情况下评估这两种干预措施的效果。该研究旨在评估中低收入国家采取两组干预措施后的效果。

研究组进行了一项2*2析因、随机对照试验，按手术是否清洁、污染或肮脏分层，招募接受腹部手术且皮肤切口大于等于5 cm的患者。这项试验在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。将患者按1:1:1:1随机分组，分别接受（1）2%酒精洗必泰和非涂层缝线；（2）2%酒精洗必泰和三氯生涂层缝线；（3）10%聚维酮-碘水溶液和非涂层缝线；（4）10%聚维酮-碘水溶液和三氯生涂层缝线。主要结局为SSI，由经过培训的结果评估员报告。通过意向治疗进行分析。

2018年12月10日至2020年9月7日，共5788例患者接受随机分组，其中清洁-污染分层3091例，污染-肮脏分层2697例；1446例使用酒精洗必泰和无涂层缝线，1446例使用酒精洗必泰和三氯生涂层缝线，1447例使用聚维酮碘水和无涂层缝线，1449使用聚维酮碘水和三氯生涂层缝合线。

14.0%（810/5788）的患者为儿童，66.9%（3873/5788）的患者进行了急诊手术。总SSI率为22.0%（1163/5284；清洁-污染分层15.5%，污染-肮脏分层30.0%）。对于这两个分层，没有证据表明酒精洗必泰与聚维酮碘水治疗SSI的风险存在差异，也没有证据表明使用三氯生涂层缝合线与非涂层缝合线的SSI风险有显著差异。结合两个分层，使用含酒精洗必泰或三氯生涂层缝线的SSI风险均无统计学差异。

研究结果表明，与聚维酮碘水相比，使用2%酒精洗必泰皮肤制剂；或与非涂层缝线相比，使用三氯生涂层缝线相，均未显示其在预防清洁、污染或肮脏的外科伤口SSI风险方面的益处。这两种干预措施的费用均高于替代方法，不支持临床常规使用。

附：英文原文

Title: Reducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trial

Author: Adesoji O Ademuyiwa, Pollyanna Hardy, Emmy Runigamugabo, Pierre Sodonougbo, Hulrich Behanzin, Sosthène Kangni, Gérard Agboton, Luke Aniakwo Adagrah, Esther Adjei-Acquah, Ato Oppong Acquah, James Ankomah, Ralph Armah, Regina Acquah, Kwame Gyambibi Addo, Dorcas Otuo Acheampong, Nii Armah Adu-Aryee, Fatao Abubakari, Abraham Titigah, Frank Owusu, Raphael Adu-Brobbey, Vivian Adobea, Francis Atindaana Abantanga, Arun Gautham, Dimple Bhatti, Esther Daniel Mark Jesudason, Manisha Aggarwal, Philip Alexander, Amos Dasari, Rahul Alpheus, Hemanth Kumar, Subrat Raul, Wenceslao ángeles Bueno, Reyes Cervantes Ortiz, Isaac Baltazar Gomez, Claudia Caballero Cerdan, Mariana Barreto Gallo, Rozana Reyes Gamez, Irani Durán Sánchez, Lawal Abdullahi, Opeoluwa Adesanya, Moruf Abdulsalam, Victoria Adeleye, Ochomma Egwuonwu, Akeem Adeleke, Francis Adebayo, Godwin Chiejina, Olukayode Abayomi, Lukman Abdur-Rahman, Jude Ede, Uba Ezinne, Salathiel Kanyarukiko, Moses Dusabe, Aime Dieudonne Hirwa, Georges Bucyibaruta, Mary Augusta Adams, Cheryl Birtles, Zain Ally, Abdus-sami Adewunmi, Jonathan Cook, Julia Brown, Adewale O Adisa, Lawani Ismail, Aneel Bhangu, Omar Omar, Joana FF Simoes, Elizabeth Li, Azmina Verjee, Pamphile Assouto, Djifid Morel Seto, Cyrile Kpangon, Rene Ahossi, Bin Baaba Alhaji Alhassan, Vera Agyekum, Leslie Issa Adam-Zakariah, Frank Assah-Adjei, Christopher Asare, James Amoako, Enoch Appiah Akosa, Jane Acquaye, Faisal Adjei, Cletus Ballu, Christian Larbi Coompson, Amos Bennin, Darling Ramatu Abdulai, Alice Hepzibah, William Bhatti, Priyadarshini K Paul, Parth Dhamija, Josy Thomas, Priya Jacob, Ashish Choudhrie, Nitin Peters, Rajeev Sharma, Francisco Barbosa Camacho, Gonzalo Hernandez Gonzalez, Celina Cuellar Aguirre, David Dominguez Solano, Ana Cortes Flores, Roque Lincona Menindez, Diana Gonzalez Vazquez, Khadija Ado, David Awonuga, Abimbola Adeniran, Adesoji Ademuyiwa, Okechukwu Ekwunife, Wilson Adenikinju, Oseremen Aisuodionoe-Shadrach, Ekpo Edet, Rukiyat Abdus-Salam, Nurudeen Adeleke, Sebastian Ekenze, Matthew Francis, Francine Mukaneza, Emelyne Izabiriza, Elysee Kabanda, Gisele Juru Bunogerane, Richard Crawford, Mathete Ivy, David Jayne, Simon Cousens, Sohini Chakrabortee, Dhruva Ghosh, Frank Enoch Gyamfi, Felicity Brant, Michel Fiogbe, Yannick Tandje, Marcelin Akpla, Raoul Baderha Ngabo, Mabel Pokuah Amoako-Boateng, Eric Agyemang, Esther Asabre, Anthony Appiah Boakye, Delali Akosua Gakpetor, Akosua Dwamena Appiah, Percy Boakye, Michael Adinku, Erica Akoto, Charles Gyamfi Barimah, Abdul-Hamid Labaran, Fred Dankwah, Daniel Kwesi Acquah, Grace Mary, Karan Bir, Latha Madankumar, Himani Gupta, Pradeep Zechariah, Elizabeth Kurien, Rakesh Vakil

Issue&Volume: 2021-10-26

Abstract:

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.

DOI: 10.1016/S0140-6736(21)01548-8

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01548-8/fulltext

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