Reducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trial. Issue 10312 (6th November 2021)

• Record Type: Journal Article
• Authors: Ademuyiwa, Adesoji O; Hardy, Pollyanna; Runigamugabo, Emmy; Sodonougbo, Pierre; Behanzin, Hulrich; Kangni, Sosthène; Agboton, Gérard; Adagrah, Luke Aniakwo; Adjei-Acquah, Esther; Acquah, Ato Oppong; Ankomah, James; Armah, Ralph; Acquah, Regina; Addo, Kwame Gyambibi; Acheampong, Dorcas Otuo; Adu-Aryee, Nii Armah; Abubakari, Fatao; Titigah, Abraham; Owusu, Frank; Adu-Brobbey, Raphael; Adobea, Vivian; Abantanga, Francis Atindaana; Gautham, Arun; Bhatti, Dimple; Jesudason, Esther Daniel Mark; Aggarwal, Manisha; Alexander, Philip; Dasari, Amos; Alpheus, Rahul; Kumar, Hemanth; Raul, Subrat; Bueno, Wenceslao Ángeles; Ortiz, Reyes Cervantes; Gomez, Isaac Baltazar; Cerdan, Claudia Caballero; Gallo, Mariana Barreto; Gamez, Rozana Reyes; Sánchez, Irani Durán; Abdullahi, Lawal; Adesanya, Opeoluwa; Abdulsalam, Moruf; Adeleye, Victoria; Egwuonwu, Ochomma; Adeleke, Akeem; Adebayo, Francis; Chiejina, Godwin; Abayomi, Olukayode; Abdur-Rahman, Lukman; Ede, Jude; Ezinne, Uba; Kanyarukiko, Salathiel; Dusabe, Moses; Hirwa, Aime Dieudonne; Bucyibaruta, Georges; Adams, Mary Augusta; Birtles, Cheryl; Ally, Zain; Adewunmi, Abdus-sami; Cook, Jonathan; Brown, Julia; Adisa, Adewale O; Ismail, Lawani; Bhangu, Aneel; Omar, Omar; Simoes, Joana FF; Li, Elizabeth; Verjee, Azmina; Assouto, Pamphile; Seto, Djifid Morel; Kpangon, Cyrile; Ahossi, Rene; Alhassan, Bin Baaba Alhaji; Agyekum, Vera; Adam-Zakariah, Leslie Issa; Assah-Adjei, Frank; Asare, Christopher; Amoako, James; Akosa, Enoch Appiah; Acquaye, Jane; Adjei, Faisal; Ballu, Cletus; Coompson, Christian Larbi; Bennin, Amos; Abdulai, Darling Ramatu; Hepzibah, Alice; Bhatti, William; Paul, Priyadarshini K; Dhamija, Parth; Thomas, Josy; Jacob, Priya; Choudhrie, Ashish; Peters, Nitin; Sharma, Rajeev; Camacho, Francisco Barbosa; Gonzalez, Gonzalo Hernandez; Aguirre, Celina Cuellar; Solano, David Dominguez; Flores, Ana Cortes; Menindez, Roque Lincona; Vazquez, Diana Gonzalez; Ado, Khadija; Awonuga, David; Adeniran, Abimbola; Ademuyiwa, Adesoji; Ekwunife, Okechukwu; Adenikinju, Wilson; Aisuodionoe-Shadrach, Oseremen; Edet, Ekpo; Abdus-Salam, Rukiyat; Adeleke, Nurudeen; Ekenze, Sebastian; Francis, Matthew; Mukaneza, Francine; Izabiriza, Emelyne; Kabanda, Elysee; Bunogerane, Gisele Juru; Crawford, Richard; Ivy, Mathete; Jayne, David; Cousens, Simon; Chakrabortee, Sohini; Ghosh, Dhruva; Gyamfi, Frank Enoch; Brant, Felicity; Fiogbe, Michel; Tandje, Yannick; Akpla, Marcelin; Ngabo, Raoul Baderha; Amoako-Boateng, Mabel Pokuah; Agyemang, Eric; Asabre, Esther; Boakye, Anthony Appiah; Gakpetor, Delali Akosua; Appiah, Akosua Dwamena; Boakye, Percy; Adinku, Michael; Akoto, Erica; Barimah, Charles Gyamfi; Labaran, Abdul-Hamid; Dankwah, Fred; Acquah, Daniel Kwesi; Mary, Grace; Bir, Karan; Madankumar, Latha; Gupta, Himani; Zechariah, Pradeep; Kurien, Elizabeth; Vakil, Rakesh; Hernández, Aldo Bernal; Krauss, Rosa Hernandez; Avendaño, Alejandro Cuevas; Garcia, Rafael Toriz; Ojeda, Alejandro Gonzalez; Peón, Alberto Navarrete; Lara, Maria Martínez; Aliyu, Mohammed; Fasiku, Olushola; Ajai, Olalekan; Adeniyi, Oluwafunmilayo; Modekwe, Victor; Adeniyi, Olumide; Akaba, Godwin; Inyang, Akan; Adebayo, Sikiru; Adesola, Muideen; Enemuo, Vincent; Ikechukwu, Iweha; Mukantibaziyaremye, Deborah; Maniraguha, Hope Lydia; Mbonimpaye, Salomee; Habumuremyi, Sosthene; Ede, Chikwendu Jeffrey; Mbavhalelo, Cynthia; Laurberg, Soren; Smart, Neil; de la Medina, Antonio Ramos; Brocklehurst, Peter; Koco, Houenoukpo; Chobli, Hugues Herve; Bisimwa, Nathan; Appiah, Anthony Baffour; Akesseh, Rebecca Adjeibah; Boateng, Ruby Acheampong; Fosu, Godfred; Gawu, Victoria Sena; Aseti, Mark; Coompson, Christian Larbi; Agbedinu, Kwabena; Ametefe, Elikem; Boateng, Guy Casskey; Owusu, Junior Atta; Doe, Stanley; Ayingayure, Emmanuel; Singh, Deepak; Daniel, Swati; Mittal, Rohin; Kanna, Vinoth; Mathew, Arpit; Arellano, Ana Bogurin; Miguelena, Luis Hernández; Sansores, Luis Dominguez; Velasco, Monica Jimenez; Muñoz, Maria Paz; Perez-Maldonado, Laura Martinez; Anyanwu, Lofty-John; Ogo, Chidiebere; Akande, Olukemi; Akinajo, Opeyemi; Okoro, Chukwuemeka; Adepiti, Akinfolarin; Ameh, Lazarus; Isa, Mary; Ajao, Akinlabi; Afolabi, Rafiat; Eze, Matthew; Nnyonno, Okoi; Munyaneza, Aphrodis; Mpirimbanyi, Christophe; Mukakomite, Christine; Haragirimana, Jean de Dieu; Fourtounas, Maria; Moore, Rachel; Chakrabortee, Sohini; Metchinhoungbe, Serge; Kovohouande, Blaise; Kandokponou, Covalic Melic Bokossa; Asante-Asamani, Alvin; Amponsah-Manu, Forster; Koomson, Barbara; Serbeh, Godwin; Obbeng, Ambe; Banka, Charles; Gyamfi, Brian; Agbeko, Anita Eseenam; Amoako, Joachim Kwaku; Luri, Prosper Tonwisi; Kantanka, Ruth Sarfo; Osman, Imoro; Dhar, Tapasya; Nagomy, Ida; Kumar, Ashwani; Prakash, Danita; Torres, Edgar Cortes; Romero, Marco Hurtado; Mejia, Hector Ortiz; de la Fuente, Alejandra Nayen Sainz; Magashi, Mahmoud; Atobatele, Kazeem; Akinboyewa, David; Uche, Chisom; Aderounmu, Adewale; Mbajiekwe, Ndubuisi; Iseh, Faith; Amusat, Olanrewaju; Agodirin, Sulaiman; Ezomike, Uchechukwu; Okoro, Philemon; Ndegamiye, Gibert; Mutuyimana, Josiane; Muroruhirwe, Piolette; Imanishimwe, Alphonsine; Hyman, Gabriella; Hardy, Pollyanna; Ntirenganya, Faustin; Sogbo, Hodonou; Dokponou, Mireille; Boakye, Benedict; Ofosu-Akromah, Richard; Kusiwaa, Ataa; Gyan, Kofi Yeboah; Ofosuhene, Doris; Dadzie, Samuel; Kontor, Bismark Effah; Amankwa, Emmanuel Gyimah; Attepor, Godsway Solomon; Kobby, Ephraim; Kunfah, Sheba; Dhiman, Jyoti; Selvakumar, Rajesh; Singh, Gurtaj; Susan, Anju; Orozco, Clotilde Fuentes; del Campo, Laura Urdapilleta Gomez; de la Medina, Antonio Ramos De; Muhammad, Abubakar; Eke, Grace; Alasi, Iyabo; Ugwuanyi, Kenneth; Adesunkanmi, Abdulhafiz; Ogbo, Felix; Marwa, Adams; Ayandipo, Omobolaji; Aremu, Isiaka; Izuka, Emmanuel; Patrick, Igwe; Tubasiime, Ronald; Mwenedata, Olivier; Ingabire, JC Allen; Khan, Zafar; Harrison, Ewen; Tabiri, Stephen; Glasbey, James; Dossou, Francis Moïse; Debrah, Samuel A; Enti, Donald; Twerefour, Emmanuel Yaw; Nyarko, Isaac Omane; Osei-Poku, Dorcas; Essien, Derick; Kyeremeh, Christian; Amoah, Michael; Brown, George Darko; Larnyor, Kennedy Kofi Korankye-Hanson; Limann, Gbana; Ghosh, Dhruva; Shankar, Bharat; Varghese, Rose; de Rojas, Erick González García; Muhammad, Saminu; Faboya, Omolara; Alakaloko, Felix; Ugwunne, Chuka; Adisa, Adewale; Olori, Samson; Ogbeche, Sunday; Egbuchulem, Kelvin; Bello, Jibril; Mbadiwe, Okezie; Raphael, John; Rwagahirima, Elisee; Mukanyange, Violette; Kwati, Morapedi; Dzemta, Corinne; Ganiyu, Rahman Adebisi; Robertson, Zelda; Puozaa, Diana; Gyamfi, Frank Enoch; Manu, Ruth; Amoah, George; Fenu, Benjamin; Osei, Edwin; Mohammed, Shamudeen Alhassan; Goyal, Sunita; Sivakumar, Moonish; Muideen, Bello; Imam, Zainab; Atoyebi, Oluwole; Ajekwu, Samuel; Osagie, Olabisi; Olory, Edima; Ekwuazi, Hyginus; Lawal, Saheed; Mbah, Ngozi; Vaduneme, Oriji; Uwizeyimana, Francine; Munyaneza, Emmanuel; Mathe, Mpho Nosipho; Haque, Parvez D; Gaou, Antoine; Koggoh, Patience; Tackie, Enoch; Hussey, Romeo; Mensah, Elijah; Appiah, Juliana; Kumassah, Philemon Kwame; Owusu, Prince Yeboah; Mohammed, Sheriff; Goyal, Ankush; Sridhar, Rajeevan; Ramírez, Bertha Guzmán; Takai, Idris; Momson, Esther; Balogun, Olanrewaju; Ajenjfuja, Olusegun; Sadiq, Abu; Udie, Gabriel; Elemile, Peter; Lawal, Abdulwahab; Victor, Abhulimen; Zirikana, Job; Mutabazi, Emmanuel; Moore, Rachel; Heritage, Emily; Goudou, Roland; Kpankpari, Richard; Temitope, Arkorful Ebenezer; Kwarteng, Jemima; Solae, Friko Ibrahim; Arthur, Joshua; Olayiwola, David Olatayo; Sie-Broni, Clement Ayum; Musah, Yakubu; Goyal, Sunita; Thomas, Cecil; Valadez, Michel Hernández Valadez; Ukata, Onyekachi; Nwaenyi, Francisca; Belie, Orimisan; Akindojutimi, Jerrie; Sani, Samuel; Udosen, Joseph; Lawal, Taiwo; Raji, Hadijat; Ncogoza, Isaie; Nhlabathi, Ncamsile Anthea; Hedefoun, Emmanuel; Opandoh, Isabella Naa M.; Sowah, Naa Anyekaa; Toffah, Gideon Kwasi; Ayim, Alex; Wordui, Theodore; Zume, Marshall; Ofori, Bernard; Hans, Monika; Titus, Devabalan; Acevedo, Diego Luna; Ogunyemi, Ayokunle; Bode, Christopher; Akinkuolie, Akinbolaji; Tabuanu, Nancy; Usang, Usang; Lawal, Olatunji; Sayomi, Olayinka; Ntirenganya, Faustin; Nxumalo, Hlengiwe Samkelisiwe; Kroese, Karolin; Houtoukpe, Sunday; Manu, Meshach Agyemang; Yeboah, Grace; Ayodeji, Emmanuel Kafui; Agboadoh, Nelson; Owusu, Emmanuel Abem; Haque, Parvez; Galaviz, Rubén Morán; Oludara, Mobolaji; Ekwesianya, Andrew; Alatise, Olusegun; Uanikhoba, Martins; Olagunju, Solomon; Shittu, Asimiyu; Nyirahabimana, Jeannette; Pattinson, Paddy; Lillywhite, Rachel; Lapitan, Carmela; Kamga, Felix; Manu, Maison Patrick Opoku; Yeboah, Cynthia; Boakye-Yiadom, Jonathan; Saba, Abdul-Hafiz; Konda, Samuel; Flores, Oscar Olvera; Omisanjo, Olufunmilade; Elebute, Olumide; Allen, Olubukola; Osuala, Peter; Urimubabo, Christian; Sentholang, Nnosa; Kiki-Migan, Eric; Mensah, Samuel; Boateng, Edward Amoah; Seidu, Anwar Sadat; Luther, Anil; Navarro, José Pérez; Oshodi, Olabode; Ezenwankwo, Francis; Amosu, Lukmon; Suleman, Bamidele; Sethoana, Mmule Evelyn; Lissauer, David; Lawani, Souliath; Morna, Martin Tangnaa; Dally, Charles; Tabiri, Stephen; Mahajan, Amit; Belmontes, Kevin Pintor; Oshodi, Yusuf; Fatuga, Adedeji; Archibong, Micheal; Takure, Augustine; Stassen, Maria Elizabeth; Magill, Laura; Lawani, Ismaïl; Nkrumah, John; Davor, Anthony; Yakubu, Mustapha; Makkar, Shalini; Marbello, Fernando Ramirez; Oyewole, Yemisi; Ihediwa, George; Arowolo, Olukayode; Thornley, Laura; Morton, Dion; Loko, René; Nortey, Michael; Gyasi-Sarpong, Christian Kofi; Yenli, Edwin Mwintiereh Ta-ang; Mandrelle, Kavita; Ramírez-González, Luis; Salami, Omotade; Jimoh, Adesola; Ayantona, Deborah; Wondoh, Paul; Nepogodiev, Dmitri; Mistry, Punam; Moutaïrou, Afissatou; Ofori, Emmanuel Owusu; Hamidu, Naabo Nuhu Noel; Michael, Vishal; Aguirre, Laura Reyes; Williams, Omolara; Kuku, Jubril; Ayinde, Ademola; Monahan, Mark; Ogouyemi, Pencome; Quartson, Elizaberth Mercy Quartson; Haruna, Iddrisu; Mukherjee, Partho; García, Ramona Rojas; Ladipo-Ajayi, Oluwaseun; Badejoko, Olusegun; Soumanou, Fouad; Kwarley, Naa; Rajappa, Reuben; Robles, Eduardo Valtierra; Makanjuola, Ayomide; Badmus, Tajudeen; Smith, Donna; Tamadaho, Pia; Lovi, Agbenya Kobla; Singh, Prashant; Mokwenyei, Olayanju; Etonyeaku, Amarachukwu; Zounon, Mack-Arthur; Nimako, Boateng; Suroy, Atul; Nwokocha, Samuel; Igbodike, Emeka; Nyadu, Bertina Beauty; Thind, Ravinder; Ogein, Olubunmi; Ijarotimi, Omotade; Opoku, Dominic; Thomas, Alen; Ojewola, Rufus; Lawal, Adedayo; Pinkney, Thomas; Osabutey, Anita; Tuli, Arti; Oladimeji, Abraham; Nana, Fayowole; Roberts, Tracy; Sagoe, Robert; Veetil, Sreejith; Olajide, Thomas; Oduanafolabi, Tunde; Tuffour, Samuel; Oluseye, Oluwaseun; Olasehinde, Olalekan; Tufour, Yaa; Seyi-Olajide, Justina; Olayemi, Olaniyi; Winkles, Neil; Yamoah, Francis Akwaw; Soibi-Harry, Adaiah; Omitinde, Stephen; Yefieye, Abiboye Cheduko; Ugwu, Aloy; Oni, Owolabi; Yorke, Joseph; Williams, Emmanuel; Onyeze, Chigozie; Orji, Ernest; Rotimi, Adewale; Salako, Abdulkadir; Solaja, Olufemi; Sowemimo, Oluwaseun; Talabi, Ademola; Tajudeen, Mohammed; Wuraola, Funmilola;
• Is Part Of: Lancet. Volume 398:Issue 10312(2021)
• Page Start: 1687
• Page End: 1699
• Publication Date: 2021-11-06
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Medicine; Electronic journals; Periodicals; 610.5
• DOI: 10.1016/S0140-6736(21)01548-8
• Languages: English
• ISSNs: 0140-6736

Abstract

Summary: 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.