Xavier Benoit D'Journo1,2, Pierre-Emmanuel Falcoz3, Marco Alifano4, Jean-Philippe Le Rochais5, Thomas D'Annoville6, Gilbert Massard3, Jean Francois Regnard4, Philippe Icard5, Charles Marty-Ane6, Delphine Trousse7, Christophe Doddoli7,8, Bastien Orsini7, Sophie Edouard8, Matthieu Million8, Nathalie Lesavre9, Anderson Loundou10, Karine Baumstarck10, Florence Peyron11, Stephane Honoré11, Stéphanie Dizier12, Aude Charvet12, Marc Leone8,9,12, Didier Raoult8, Laurent Papazian13, Pascal Alexandre Thomas7,8. 1. Service de Chirurgie Thoracique, Chemin des Bourrely, Hôpital Nord, Assistance Publique Hôpitaux de Marseille, Aix-Marseille University, 13915, Marseille cedex 20, France. xavier.djourno@ap-hm.fr. 2. Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE),UM63, CNRS 7278, IRD 198 INSERM U1095, Institut Hospitalo-Universitaire Méditerranée Infection, Marseille Aix-Marseille Univ., Marseille, France. xavier.djourno@ap-hm.fr. 3. Service de Chirurgie Thoracique, Nouvel Hôpital Civil, Strasbourg University, Strasbourg, France. 4. Service de Chirurgie Thoracique, Hôpital Cochin, Assistance Publique Hôpitaux de Paris, Paris Descartes University, Paris, France. 5. Service de Chirurgie Thoracique, Hôpital de la côte de Nacre, Caen University, Caen, France. 6. Service de Chirurgie Thoracique, Hôpital Arnaud de Villeneuve, Montpellier University, Montpellier, France. 7. Service de Chirurgie Thoracique, Chemin des Bourrely, Hôpital Nord, Assistance Publique Hôpitaux de Marseille, Aix-Marseille University, 13915, Marseille cedex 20, France. 8. Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE),UM63, CNRS 7278, IRD 198 INSERM U1095, Institut Hospitalo-Universitaire Méditerranée Infection, Marseille Aix-Marseille Univ., Marseille, France. 9. Centre d'Investigation Clinique, Hôpital Nord, Assistance Publique Hôpitaux de Marseille, Aix-Marseille University, Marseille, France. 10. Unité d'aide méthodologique, Assistance Publique Hôpitaux de Marseille, Aix-Marseille University, Marseille, France. 11. Service Clinique de Pharmacologie, Assistance Publique Hôpitaux de Marseille, Aix-Marseille University, Marseille, France. 12. Service d'Anesthésie-Réanimation, Hôpital Nord, Assistance Publique Hôpitaux de Marseille, Aix-Marseille University, Marseille, France. 13. Réanimation des Détresses Respiratoires et Infections Sévères, Hôpital Nord, Assistance Publique Hôpitaux de Marseille, Aix-Marseille University, Marseille, France.
Abstract
PURPOSE: Respiratory complications are the leading causes of morbidity and mortality after lung cancer surgery. We hypothesized that oropharyngeal and nasopharyngeal decontamination with chlorhexidine gluconate (CHG) would be an effective method to reduce these complications as reported in cardiac surgery. METHODS: In this multicenter parallel-group randomized double-blind placebo-controlled trial, we enrolled consecutive adults scheduled for anatomical pulmonary resection for lung cancer. Perioperative decontamination consisted in oropharyngeal rinse solution (0.12% CHG) and nasopharyngeal soap (4% CHG) or a placebo. The primary outcome measure was the proportion of patients requiring postoperative invasive and/or noninvasive mechanical ventilation (MV). Secondary outcome measures included occurrence of respiratory and non-respiratory healthcare-associated infections (HAIs) and outcomes within 90 days. RESULTS:Between July 2012 and April 2015, 474 patients were randomized. Of them, 24 had their surgical procedure cancelled or withdrew consent. The remaining 450 patients were included in a modified intention-to-treat analysis: 226 were allocated toCHG and 224 to the placebo. Proportions of patients requiring postoperative MV were not significantly different [CHG 14.2%; placebo 15.2%; relative risks (RRs) 0.93; 95% confidence interval (CI) 0.59-1.45; P = 0.76]. Neither of the proportions of patients with respiratory HAIs were different (CHG 13.7%; placebo 12.9%; RRs 1.06; 95% CI 0.66-1.69; P = 0.81). The CHG group had significantly decreased incidence of bacteremia, surgical-site infection and overall Staphylococcus aureus infections. However, there were no significant between-group differences for hospital stay length, change in tracheal microbiota, postoperative antibiotic utilization and outcomes by day 90. CONCLUSIONS:CHG decontamination decreased neither MV requirements nor respiratory infections after lung cancer surgery. Additionally, CHG did not change tracheal microbiota or postoperative antibiotic utilization. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov, number NCT01613365.
RCT Entities:
PURPOSE: Respiratory complications are the leading causes of morbidity and mortality after lung cancer surgery. We hypothesized that oropharyngeal and nasopharyngeal decontamination with chlorhexidine gluconate (CHG) would be an effective method to reduce these complications as reported in cardiac surgery. METHODS: In this multicenter parallel-group randomized double-blind placebo-controlled trial, we enrolled consecutive adults scheduled for anatomical pulmonary resection for lung cancer. Perioperative decontamination consisted in oropharyngeal rinse solution (0.12% CHG) and nasopharyngeal soap (4% CHG) or a placebo. The primary outcome measure was the proportion of patients requiring postoperative invasive and/or noninvasive mechanical ventilation (MV). Secondary outcome measures included occurrence of respiratory and non-respiratory healthcare-associated infections (HAIs) and outcomes within 90 days. RESULTS: Between July 2012 and April 2015, 474 patients were randomized. Of them, 24 had their surgical procedure cancelled or withdrew consent. The remaining 450 patients were included in a modified intention-to-treat analysis: 226 were allocated to CHG and 224 to the placebo. Proportions of patients requiring postoperative MV were not significantly different [CHG 14.2%; placebo 15.2%; relative risks (RRs) 0.93; 95% confidence interval (CI) 0.59-1.45; P = 0.76]. Neither of the proportions of patients with respiratory HAIs were different (CHG 13.7%; placebo 12.9%; RRs 1.06; 95% CI 0.66-1.69; P = 0.81). The CHG group had significantly decreased incidence of bacteremia, surgical-site infection and overall Staphylococcus aureus infections. However, there were no significant between-group differences for hospital stay length, change in tracheal microbiota, postoperative antibiotic utilization and outcomes by day 90. CONCLUSIONS:CHG decontamination decreased neither MV requirements nor respiratory infections after lung cancer surgery. Additionally, CHG did not change tracheal microbiota or postoperative antibiotic utilization. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov, number NCT01613365.
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