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

著者: 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, Khadija Ado, David Awonuga, Abimbola Adeniran, Adesoji Ademuyiwa, Okechukwu Hyginus Ekwunife, Wilson Adenikinju, Oseremen I. Aisuodionoe-Shadrach, Ekpo Edet, Rukiyat A Abdus-Salam, Nurudeen Abiola Adeleke, Sebastian O. 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 Armand 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 O. Adinku, Erica Akoto, Charles Gyamfi Barimah, Abdul-Hamid Labaran, Fred Dankwah, Daniel Acquah, Grace Mary, Karan Bir, Latha Madankumar, Himani Gupta, Pradeep Zechariah, Elizabeth Kurien, Rakesh Vakil, Aldo Bernal Hernández, Rosa Hernandez Krauss, Alejandro Cuevas Avendaño, Rafael Toriz Garcia, Alejandro González‐Ojeda, Alberto N. Peón, Maria Martínez Lara, Mohammed Aliyu, Olushola Fasiku, Olalekan Ajai, Oluwafunmilayo Funke Adeniyi, Victor Ifeanyichukwu Modekwe, Olumide Adeniyi, Godwin Akaba, Akan Inyang, Sikiru Adebayo, Muideen Adesola, Vincent Enemuo, Iweha Ikechukwu, Deborah Mukantibaziyaremye, Hope Lydia Maniraguha, Salomee Mbonimpaye, Sosthene Habumuremyi, Chikwendu Jeffrey Ede, Cynthia Mbavhalelo, Søren Laurberg, Neil Smart, Antonio Ramos de la Medina, Peter Brocklehurst, Houénoukpo Koco, Hugues Herve Chobli, Nathan Bisimwa, Anthony Baffour Appiah, Rebecca Adjeibah Akesseh, Ruby Acheampong Boateng, Godfred Fosu, Victoria Sena Gawu, Mark Aseti, Christian Larbi Coompson, Kwabena Agbedinu, Christian Larbi Coompson, Guy Casskey Boateng, Junior Atta Owusu, Stanley Doe, Emmanuel Ayingayure, Deepak Singh, Emmanuel Ayingayure, Rohin Mittal, Vinoth Kanna, Arpit Mathew, Ana Bogurin Arellano, Luis Hernández Miguelena, Luis Dominguez Sansores, Monica Jimenez Velasco, María Paz Muñoz, Laura Martínez Pérez-Maldonado, Lofty‐John Anyanwu, Chidiebere Ogo, Olukemi Akande, Opeyemi Akinajo, Chukwuemeka Chukwubuikem Okoro, Akinfolarin Adepiti, Lazarus Ameh, Mary Isa, Akinlabi Ajao, Rafiat Afolabi, Matthew Eze, Okoi Nnyonno, Aphrodis Munyaneza, Christophe Mpirimbanyi, Christine Mukakomite, Jean de Dieu Haragirimana, Maria Fourtounas, Rachel Moore, Sohini Chakrabortee, Serge Metchinhoungbe, Blaise Kovohouande, Covalic Melic Bokossa Kandokponou, Alvin Asante-Asamani, Forster Amponsah‐Manu, Barbara Koomson, Godwin Serbeh, Ambe Obbeng, Charles Banka, Brian Gyamfi, Anita Eseenam Agbeko, Joachim Kwaku Amoako, Prosper Tonwisi Luri, Ruth Sarfo Kantanka, Osman Imoro, Tapasya Dhar, Ida Nagomy, Vinod Kumar, Danita Prakash, Edgar Cortes Torres, Marco Hurtado Romero, Hector Ortiz Mejia, Alejandra Nayen Sainz de la Fuente, Mahmoud Kawu Magashi, Kazeem Atobatele, David Akinboyewa, Chisom Uche, Adewale Aderounmu, Ndubuisi Mbajiekwe, Faith Iseh, Olanrewaju Amusat, Sulaiman Agodirin, Uchechukwu Ezomike, Philemon E. Okoro, Gibert Ndegamiye, Josiane Mutuyimana, Piolette Muroruhirwe, Alphonsine Imanishimwe, Gabriella Hyman, Pollyanna Hardy, Faustin Ntirenganya, Hodonou Sogbo, Mireille Dokponou, Benedict Boakye, Richard Ofosu-Akromah, Ataa Kusiwaa, Kofi Yeboah Gyan, Doris Ofosuhene, Samuel Dadzie, Bismark Effah Kontor, Emmanuel Gyimah Amankwa, Godsway Solomon Attepor, Ephraim Kobby, Sheba Kunfah, Jyoti Dhiman, Rajesh Selvakumar, Gurtaj Singh, Anju Susan, Clotilde Fuentes Orozco, Laura Urdapilleta Gomez del Campo, Antonio Ramos De de la Medina, Abubakar Bala Muhammad, Grace Eke, Iyabo Alasi, Kenneth Ugwuanyi, Abdulhafiz Adesunkanmi, Felix Akpojene Ogbo, Adams Marwa, Omobolaji Ayandipo, Isiaka Aremu, Emmanuel Izuka, Igwe Patrick, Ronald Tubasiime, Olivier Mwenedata, JC Allen Ingabire, Zafar K. Khan, Ewen M. Harrison, Stephen Tabiri, James Glasbey, Francis Moïse Dossou, Samuel Debrah, Donald Enti, Emmanuel Yaw Twerefour, Isaac Omane Nyarko, Dorcas Osei-Poku, Derick Essien, Christian Kyeremeh, Michael Amoah, George Darko Brown, Kennedy Kofi Korankye-Hanson Larnyor, Gbana Limann, Dhruva Ghosh, Bharat Shankar, Rose Varghese, Erick González García de Rojas, Saminu Muhammad, Omolara Faboya, Felix Alakaloko, Chuka Ugwunne, Adewale Adisa, Samson Olori, Sunday Ogbeche, K I Egbuchulem, Jibril Oyekunle Bello, Okezie Mbadiwe, John Raphael, Elisée Rwagahirima, Violette Mukanyange, Morapedi Kwati, Corinne Dzemta, Rahman Adebisi Ganiyu, Zelda Robertson, Diana Puozaa, Frank Enoch Gyamfi, Ruth Manu, George Amoah, Benjamin Fenu, Edwin Osei, Shamudeen Alhassan Mohammed, Sunita Goyal, Moonish Sivakumar, Bello Muideen, Zainab Imam, Oluwole Atoyebi, Samuel Ajekwu, Olabisi Osagie, Edima Olory, Hyginus Ekwuazi, Saheed Lawal, Ngozi Mbah, Oriji Vaduneme, Francine Uwizeyimana, Emmanuel Munyaneza, Mpho Nosipho Mathe, Parvez Haque, Antoine Gaou, Patience Koggoh, Enoch Tackie, Romeo Hussey, Elijah Mensah, Juliana Appiah, Philemon Kwame Kumassah, Prince Yeboah Owusu, Philemon Kwame Kumassah, Ankush Goyal, Rajeevan Philip Sridhar, Bertha Guzmán Ramírez, Idris Usman Takai, Esther Momson, Olanrewaju Balogun, Olusegun Ajenjfuja, Olanrewaju Balogun, Gabriel Udie, Peter Elemile, Abdulwahab Lawal, Abhulimen Victor, Job Zirikana, Emmanuel Mutabazi, Rachel Moore, Emily Heritage, Roland Goudou, Richard Kpankpari, Arkorful Ebenezer Temitope, Jemima Kwarteng, Friko Ibrahim Solae, Joshua Arthur, David Olatayo Olayiwola, Clement Ayum Sie-Broni, Yakubu Musah, Sunita Goyal, Cecil Thomas, Michel Hernández Valadez Valadez, Onyekachi Ukata, Francisca Nwaenyi, Orimisan Belie, Jerrie Akindojutimi, Samuel Ali Sani, Joseph Udosen, Taiwo Lawal, Hadijat Olaide Raji, Isaie Ncogoza, Ncamsile Anthea Nhlabathi, Emmanuel Hedefoun, Isabella Naa M. Opandoh, Naa Anyekaa Sowah, Gideon Kwasi Toffah, Alex Ayim, Theodore Wordui, Marshall Zume, Bernard Ofori, Monika Hans, Devabalan Titus, Diego Luna Acevedo, Ayokunle Ogunyemi, Christopher Bode, Akinbolaji Akinkuolie, Nancy Tabuanu, Usang Usang, Olatunji O. Lawal, Olayinka Sayomi, Faustin Ntirenganya, Hlengiwe Samkelisiwe Nxumalo, Karolin Kroese, Sunday Houtoukpe, Meshach Agyemang Manu, Grace Yeboah, Emmanuel Kafui Ayodeji, Nelson Agboadoh, Emmanuel Abem Owusu, Parvez Haque, Rubén Morán Galaviz, Mobolaji Oludara, Andrew Chiagozie Ekwesianya, Olusegun Isaac Alatise, Martins Uanikhoba, Solomon Olagunju, Asimiyu Shittu, Jeannette Nyirahabimana, Paddy Pattinson, Rachel Lillywhite, Carmela Lapitan, Felix Kamga, Maison Patrick Opoku Manu, Cynthia Osei Yeboah, Jonathan Boakye-Yiadom, Abdul-Hafiz Saba, Samuel Konda, Oscar Olvera Flores, Olufunmilade Omisanjo, Olumide Elebute, Olubukola Allen, Peter Osuala, Christian Urimubabo, Nnosa Sentholang, Eric Kiki-Migan, Samuel Mensah, Edward Amoah Boateng, Anwar Sadat Seidu, Anil Luther, José Pérez Navarro, Olabode Oshodi, Francis Ezenwankwo, Lukmon Amosu, Bamidele Suleman, Mmule Evelyn Sethoana, D. Lissauer, Mmule Evelyn Sethoana, Martin Tangnaa Morna, Charles Dally, Stephen Tabiri, Amit Mahajan, Kevin Pintor Belmontes, Yusuf A. Oshodi, Adedeji Fatuga, Micheal Archibong, Augustine Takure, Maria Elizabeth Stassen, Laura Magill, Ismaïl Lawani, John Nkrumah, Anthony Davor, Mustapha Yakubu, Shalini Makkar, Fernando Ramirez Marbello, Yemisi Oyewole, George Ihediwa, Olukayode Arowolo, Laura Thornley, Dion Morton, René Loko, Michael Nortey, Christian Kofi Gyasi-Sarpong, Edwin Mwintiereh Ta-ang Yenli, Kavita Mandrelle, Luis Ricardo Ramírez-González, Omotade Salami, Adesola Jimoh, Deborah Ayantona, Paul Wondoh, Dmitri Nepogodiev, Punam Mistry, Afissatou Moutaïrou, Emmanuel Owusu Ofori, Naabo Nuhu Noel Hamidu, Vishal Michael, Laura Reyes Aguirre, Omolara Williams, Jubril Kuku, Ademola Ayinde, Mark Monahan, Pencome Ogouyemi, Elizaberth Mercy Quartson Quartson, Iddrisu Haruna, Partho Mukherjee, Ramona Rojas García, Oluwaseun Ladipo‐Ajayi, Olusegun Badejoko, Fouad Soumanou, Naa Kwarley, Reuben Rajappa, Eduardo Valtierra Robles, Ayomide Makanjuola, Tajudeen A. Badmus, Donna Smith, Pia Tamadaho, Agbenya Kobla Lovi, Prashant Singh, Olayanju Mokwenyei, Amarachukwu Etonyeaku, Mack-Arthur Zounon, Boateng Nimako, Atul Suroy, Samuel Nwokocha, Emeka Philip Igbodike, Bertina Beauty Nyadu, Ravinder Singh Thind, Olubunmi Ogein, Omotade Adebimpe Ijarotimi, Dominic Opoku, Alen Thomas, Rufus Wale Ojewola, Adedayo Lawal, Thomas Pinkney, Anita Osabutey, Arti Tuli, Abraham Oladimeji, Fayowole Nana, Abraham Oladimeji, Robert Sagoe, Sreejith Kannummal Veetil, Thomas Olajide, Tunde Oduanafolabi, Samuel Tuffour, Oluwaseun Oluseye, Olalekan Olasehinde, Yaa Tufour, Justina O. Seyi‐Olajide, Olaniyi Olayemi, Neil Winkles, Francis Akwaw Yamoah, Adaiah Soibi‐Harry, Stephen Omitinde, Abiboye Cheduko Yefieye, Aloy Okechukwu Ugwu, Owolabi Oni, Joseph Yorke, Emmanuel Williams, Chigozie Onyeze, Ernest O. Orji, Adewale Rotimi, Abdulkadir Ayo Salako, Olufemi Solaja, Oluwaseun Sowemimo, Ademola Olusegun Talabi, Mohammed Tajudeen, Funmilola Wuraola, Mohammed Tajudeen, Funmilola Wuraola - The Lancet 2021 被引用: 130

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.