1. Multicentre, open-label, randomised, controlled clinical trial comparing 2% chlorhexidine-70% isopropanol and 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery: the CLEAN 2 study protocol
- Author
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Boisson, Matthieu, Corbi, Pierre, Kerforne, Thomas, Camilleri, Lionel, Debauchez, Mathieu, Demondion, Pierre, Eljezi, Vedat, Flecher, Erwan, Lepelletier, Didier, Leprince, Pascal, Nesseler, Nicolas, Nizou, Jacques Yves, Roussel, Jean Christian, Rozec, Bertrand, Ruckly, Stéphane, Lucet, Jean-Christophe, Timsit, Jean-François, Mimoz, Olivier, Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'anesthésie réanimation [Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), CHU Poitiers, Service de chirurgie cardio-thoracique, Poitiers, 86000, France, Service de chirurgie cardiaque, CHU Clermont-Ferrand, Institut Mutualiste de Montsouris (IMM), Service de Chirurgie Thoracique et Cardiovasculaire [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Centre Hospitalier Universitaire (CHU) Clermont-Ferrand, Département Anesthésie et Réanimation, Hôpital Estaing, Université Clermont Auvergne, Service de chirurgie thoracique cardiaque et vasculaire [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Service de Bactériologie - Hygiène Hospitalière [CHU Nantes], Centre hospitalier universitaire de Nantes (CHU Nantes), Département d'anesthésie réanimation [Rennes], Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-CHU Pontchaillou [Rennes], Département de chirurgie thoracique et cardiovasculaire [CHU Nantes], Unité de Soins Intensifs [CHU Nantes] (Département d'anesthésie et de soins intensifs), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Sorbonne Paris Nord, Hôpital Bichat - Claude Bernard, Services de Maladies Infectieuses et Tropicales [CHU Bichat], AP-HP - Hôpital Bichat - Claude Bernard [Paris], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service d'Anésthésie Réanimation [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service de chirurgie thoracique cardiaque et vasculaire [Rennes] = Thoracic and Cardiovascular Surgery [Rennes], CHU Pontchaillou [Rennes], Service d'anesthésie réanimation chirurgicale [Rennes], Université de Rennes (UR)-Hôpital Pontchaillou, Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Chirurgie cardiaque et thoracique [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), HAL UR1, Admin, Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Pontchaillou-Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)
- Subjects
surgical-site infection ,Ethanol ,povidone iodine ,Administration, Topical ,[SDV]Life Sciences [q-bio] ,chlorhexidine ,Antisepsis ,skin antisepsis ,[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences ,2-Propanol ,[SDV] Life Sciences [q-bio] ,[SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences ,Treatment Outcome ,Clinical Protocols ,Preoperative Care ,Protocol ,Anti-Infective Agents, Local ,Humans ,Surgical Wound Infection ,Surgery ,Cardiac Surgical Procedures ,Povidone-Iodine ,cardiac surgery - Abstract
Introduction Surgical-site infection (SSI) is the second most frequent cause of healthcare-associated infection worldwide and is associated with increased morbidity, mortality and healthcare costs. Cardiac surgery is clean surgery with low incidence of SSI, ranging from 2% to 5%, but with potentially severe consequences. Perioperative skin antisepsis with an alcohol-based antiseptic solution is recommended to prevent SSI, but the superiority of chlorhexidine (CHG)–alcohol over povidone iodine (PVI)–alcohol, the two most common alcohol-based antiseptic solutions used worldwide, is controversial. We aim to evaluate whether 2% CHG–70% isopropanol is more effective than 5% PVI–69% ethanol in reducing the incidence of reoperation after cardiac surgery. Methods and analysis The CLEAN 2 study is a multicentre, open-label, randomised, controlled clinical trial of 4100 patients undergoing cardiac surgery. Patients will be randomised in 1:1 ratio to receive either 2% CHG–70% isopropanol or 5% PVI–69% ethanol for perioperative skin preparation. The primary endpoint is the proportion of patients undergoing any re-sternotomy between day 0 and day 90 after initial surgery and/or any reoperation on saphenous vein/radial artery surgical site between day 0 and day 30 after initial surgery. Data will be analysed on the intention-to-treat principle. Ethics and dissemination This protocol has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. Trial registration number EudraCT 2017-005169-33 and NCT03560193.
- Published
- 2019