Reducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trial
Adesoji 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 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, Victoria Adeleye, Akeem Adeleke, Francis Adebayo, Godwin Chiejina, Olukayode Abayomi, LO 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 Adisa, Ismaïl Lawani, Aneel Bhangu, Omar Omar, Joana F F Simoes, Elizabeth Li, Azmina Verjee, Pamphile Assouto, Djifid Morel Séto, Cyrile Kpangon, Rene Ahossi, Baba Alhaji Bin 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 Mary Jacob, Ashish Choudhrie, Nitin James Peters, Rajeev Sharma, Francisco José Barbosa‐Camacho, Gonzalo Hernandez Gonzalez, Celina Cuellar Aguirre, David Dominguez Solano, Ana Cortes Flores, Roque Lincona Menindez, Diana Gonzalez Vazquez
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. FUNDING: National Institute for Health Research (NIHR) Global Health Research Unit Grant, BD.