{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T11:14:05Z","timestamp":1790507645342,"version":"4.1.0"},"reference-count":19,"publisher":"BMJ","issue":"6","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2019,6]]},"abstract":"\n Introduction<\/jats:title>\n Surgical-site infection (SSI) is the second most frequent cause of\n healthcare-associated infection worldwide and is associated with\n increased morbidity, mortality and healthcare costs. Cardiac surgery is\n clean surgery with low incidence of SSI, ranging from 2% to 5%, but with\n potentially severe consequences.<\/jats:p>\n Perioperative skin antisepsis with an alcohol-based antiseptic\n solution is recommended to prevent SSI, but the superiority of\n chlorhexidine (CHG)\u2013alcohol over povidone iodine (PVI)\u2013alcohol, the two\n most common alcohol-based antiseptic solutions used worldwide, is\n controversial. We aim to evaluate whether 2% CHG\u201370% isopropanol is more\n effective than 5% PVI\u201369% ethanol in reducing the incidence of\n reoperation after cardiac surgery.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n The CLEAN 2 study is a multicentre, open-label, randomised,\n controlled clinical trial of 4100 patients undergoing cardiac surgery.\n Patients will be randomised in 1:1 ratio to receive either 2% CHG\u201370%\n isopropanol or 5% PVI\u201369% ethanol for perioperative skin preparation.\n The primary endpoint is the proportion of patients undergoing any\n re-sternotomy between day 0 and day 90 after initial surgery and\/or any\n reoperation on saphenous vein\/radial artery surgical site between day 0\n and day 30 after initial surgery. Data will be analysed on the\n intention-to-treat principle.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n This protocol has been approved by an independent ethics committee\n and will be carried out according to the principles of the Declaration\n of Helsinki and the Good Clinical Practice guidelines. The results of\n this study will be disseminated through presentation at scientific\n conferences and publication in peer-reviewed journals.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n EudraCT 2017-005169-33 and NCT03560193.<\/jats:ext-link><\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-026929","type":"journal-article","created":{"date-parts":[[2021,5,10]],"date-time":"2021-05-10T16:30:01Z","timestamp":1620664201000},"page":"e026929","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Multicentre, open-label, randomised, controlled clinical trial comparing\n 2% chlorhexidine\u201370% isopropanol and 5% povidone iodine\u201369% ethanol for skin\n antisepsis in reducing surgical-site infection after cardiac surgery: the\n CLEAN 2 study protocol"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct03560193","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3667-5782","authenticated-orcid":false,"given":"Matthieu","family":"Boisson","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Corbi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Kerforne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lionel","family":"Camilleri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathieu","family":"Debauchez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Demondion","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vedat","family":"Eljezi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erwan","family":"Flecher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Didier","family":"Lepelletier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascal","family":"Leprince","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Nesseler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacques Yves","family":"Nizou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean Christian","family":"Roussel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bertrand","family":"Rozec","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phane","family":"Ruckly","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Christophe","family":"Lucet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Fran\u00e7ois","family":"Timsit","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1737-7915","authenticated-orcid":false,"given":"Olivier","family":"Mimoz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,6,17]]},"reference":[{"key":"2021051009024726000_9.6.e026929.1","unstructured":"World Health Organization. Report on the burden of\n endemic health care-associated infection worldwide. Geneva: World Health\n Organization, 2011."},{"key":"2021051009024726000_9.6.e026929.2","unstructured":"European Centre for Disease Prevention and Control.\n Annual epidemiological report 2014. Antimicrobial resistance and\n healthcare-associated infections. 2015\n http:\/\/ecdc.europa.eu\/en\/publications\/Publications\/antimicrobial-resistance-annual-epidemiological-report.pdf\n (Accessed 26 Apr 2016)."},{"key":"2021051009024726000_9.6.e026929.3","unstructured":"European Centre for Disease Prevention and Control.\n Surveillance of surgical site infections in Europe 2010\u20132011. Eur. Cent.\n Dis\u00a0Prev. Control 2013\n http:\/\/ecdc.europa.eu\/sites\/portal\/files\/media\/en\/publications\/Publications\/SSI-in-europe-2010-2011.pdf\n (Accessed 24 Oct 2017)."},{"key":"2021051009024726000_9.6.e026929.4","unstructured":"World Health Organization. Global guidelines on the\n prevention of surgical site infection. Geneva: World Health\n Organization, 2016."},{"key":"2021051009024726000_9.6.e026929.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajic.2005.07.002"},{"key":"2021051009024726000_9.6.e026929.6","doi-asserted-by":"crossref","first-page":"674.e11","DOI":"10.1016\/j.cmi.2015.03.025","article-title":"Sternal wound infection after cardiac surgery: incidence and\n risk factors according to clinical presentation","volume":"21","author":"Lemaignen","year":"2015","journal-title":"Clin Microbiol Infect"},{"key":"2021051009024726000_9.6.e026929.7","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0810988"},{"key":"2021051009024726000_9.6.e026929.8","doi-asserted-by":"crossref","first-page":"1251","DOI":"10.1097\/AOG.0000000000001118","article-title":"Skin Preparation for Prevention of Surgical Site Infection\n After Cesarean Delivery: A Randomized Controlled Trial","volume":"126","author":"Ngai","year":"2015","journal-title":"Obstet Gynecol"},{"key":"2021051009024726000_9.6.e026929.9","doi-asserted-by":"crossref","first-page":"647","DOI":"10.1056\/NEJMoa1511048","article-title":"A randomized trial comparing skin antiseptic agents at\n cesarean delivery","volume":"374","author":"Tuuli","year":"2016","journal-title":"N Engl J Med"},{"key":"2021051009024726000_9.6.e026929.10","doi-asserted-by":"crossref","first-page":"e145","DOI":"10.1002\/bjs.10395","article-title":"Randomized clinical trial of preoperative skin antisepsis\n with chlorhexidine gluconate or povidone-iodine","volume":"104","author":"Park","year":"2017","journal-title":"Br J Surg"},{"key":"2021051009024726000_9.6.e026929.11","doi-asserted-by":"crossref","first-page":"946","DOI":"10.1097\/SLA.0000000000002189","article-title":"Randomized controlled trial of two alcohol-based preparations\n for surgical site antisepsis in colorectal surgery","volume":"266","author":"Broach","year":"2017","journal-title":"Ann Surg"},{"key":"2021051009024726000_9.6.e026929.12","doi-asserted-by":"publisher","DOI":"10.1086\/657134"},{"key":"2021051009024726000_9.6.e026929.13","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.7214"},{"key":"2021051009024726000_9.6.e026929.14","doi-asserted-by":"publisher","DOI":"10.1086\/665723"},{"key":"2021051009024726000_9.6.e026929.15","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(16)30398-X"},{"key":"2021051009024726000_9.6.e026929.16","unstructured":"SFAR. Antibioprophylaxie en chirurgie et m\u00e9decine\n interventionnelle (patients adultes). 2018\n https:\/\/sfar.org\/antibioprophylaxie-en-chirurgie-et-medecine-interventionnelle-patients-adultes-maj2018\/\n (Accessed 7 Jan 2019)."},{"key":"2021051009024726000_9.6.e026929.17","unstructured":"Center for Disease Control and Prevention, National\n Healthcare Safety Network. Surveillance definitions for specific types\n of infections.\n https:\/\/www-cdc-gov.gate2.inist.fr\/nhsn\/pdfs\/pscmanual\/17pscnosinfdef_current.pdf\n (Accessed 8 Jul 2018)."},{"key":"2021051009024726000_9.6.e026929.18","doi-asserted-by":"crossref","unstructured":"Edwards PS , Lipp A , Holmes A . Preoperative skin\n antiseptics for preventing surgical wound infections after clean\n surgery. Cochrane Database Syst Rev\n 2004:CD003949.doi:10.1002\/14651858.CD003949.pub2","DOI":"10.1002\/14651858.CD003949.pub2"},{"key":"2021051009024726000_9.6.e026929.19","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)00244-5"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2018-026929","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,5,10]],"date-time":"2021-05-10T16:30:25Z","timestamp":1620664225000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2018-026929"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,6]]},"references-count":19,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2019,6,17]]},"published-print":{"date-parts":[[2019,6]]}},"alternative-id":["10.1136\/bmjopen-2018-026929"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2018-026929","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,6]]}}}