Chlorhexidine-alcohol compared with povidone-iodine-alcohol skin antisepsis protocols in major cardiac surgery: a randomized clinical trial

被引:0
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作者
Boisson, Matthieu [1 ]
Allain, Geraldine [2 ]
Roussel, Jean-Christian [3 ]
d'Ostrevy, Nicolas [4 ]
Burbassi, Silvia [5 ]
Demondion, Pierre [6 ]
Mertes, Paul-Michel [7 ]
Labaste, Francois [8 ]
Kerforne, Thomas [9 ]
Rozec, Bertrand [10 ]
Eljezi, Vedat [11 ]
Zannis, Konstantinos [12 ]
Leprince, Pascal [6 ]
Oulehri, Walid [13 ]
Minville, Vincent [8 ]
Seguin, Sabrina [14 ]
Loiodice, Ambre [15 ]
Ruckly, Stephane [16 ]
Lucet, Jean-Christophe [17 ]
Timsit, Jean-Francois [18 ,19 ]
Mimoz, Olivier [20 ]
机构
[1] Univ Poitiers, Serv Anesthesie Reanimat & Med Peri Operatoire, INSERM U1070 PHAR2, CHU Poitiers, Poitiers, France
[2] Univ Poitiers, Serv Chirurg Cardiothorac & Vasc, INSERM IRMETIST U1313, CHU Poitiers, Poitiers, France
[3] Nantes Univ, Hop G&R Laennec, Serv Chirurg Cardiothorac, CHU Nantes, Nantes, France
[4] CHU Clermont Ferrand, Serv Chirurg Cardiovasc, Clermont Ferrand, France
[5] Inst Mutualiste Montsouris, Unite Rech Clin, Paris, France
[6] Sorbonne Univ, AP HP, Cardiol Inst, INSERM,UMRS 1166 ICAN,Inst Cardiometab & Nutr,Dep, Paris, France
[7] Univ Strasbourg, Hop Univ Strasbourg, Pole Anesthesie Reanimat & Med Perioperatoire, Strasbourg, France
[8] Univ Toulouse 3, Serv Anesthesie Reanimat & Medecine Peri Operatoir, INSERM RESTAURE UMR CNRS 1301 5070, CHU Toulouse, Toulouse, France
[9] Univ Poitiers, Serv Anesthesie Reanimat & Med Peri Operatoire, INSERM IRMETIST U1313, CHU Poitiers, Poitiers, France
[10] Nantes Univ, Hop G&R Laennec, CHU Nantes, CNRS,INSERM,Inst Thorax Serv Anesthesie & Reanimat, Nantes, France
[11] Univ Clermont Auvergne, CHU Gabriel Montpied, Pole Med Peri Operatoire, Clermont Ferrand, France
[12] Inst Mutualiste Montsouris, Serv Chirurg Card, Paris, France
[13] Hop Univ Strasbourg, Pole Anesthesie Reanimat & Med Perioperatoire, Strasbourg, France
[14] CHU Poitiers, Serv Anesthesie Reanimat & Med Peri Operatoire, Poitiers, France
[15] ICURESEARCH, Fontaine, France
[16] OUTCOME REA Res Network, Dept Biostat, Drancy, France
[17] Bichat Claude Bernard Hosp, AP HP, INSERM, IAME,U1137,Team DeSCID,Infect Control Unit, Paris, France
[18] Univ Paris Cite, AP HP, AP HP, INSERM,IAME,U1137,Team DeSCID,Med & Infect Dis ICU, Paris, France
[19] OUTCOME REA Res Network, Drancy, France
[20] CHU Poitiers, CHU Poitiers, INSERM U1070 PHAR2, Serv Urgences Adultes SAMU Ctr 86 15, F-86000 Poitiers, France
关键词
Skin antisepsis; Cardiac surgery; Surgical site infection; Chlorhexidine; Povidone iodine; SURGICAL-SITE INFECTIONS; RISK-FACTORS; OPEN-LABEL; MEDIASTINITIS; PREVENTION;
D O I
10.1007/s00134-024-07693-0
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
PurposeWhether skin disinfection of the surgical site using chlorhexidine-alcohol is superior to povidone-iodine-alcohol in reducing reoperation and surgical site infection rates after major cardiac surgery remains unclear.MethodsCLEAN 2 was a multicenter, open-label, randomized, two-arm, assessor-blind, superiority trial conducted in eight French hospitals. We randomly assigned adult patients undergoing major heart or aortic surgery via sternotomy, with or without saphenous vein or radial artery harvesting, to have all surgical sites disinfected with either 2% chlorhexidine-alcohol or 5% povidone-iodine-alcohol. The primary outcome was any resternotomy by day 90 or any reoperation at the peripheral surgical site by day 30.ResultsOf 3242 patients (1621 in the chlorhexidine-alcohol group [median age, 69 years; 1276 (78.7%) men] and 1621 in the povidone-iodine-alcohol group [median age, 69 years; 1247 (76.9%) men], the percentage required reoperation within 90 days was similar (7.7% [125/1621] in the chlorhexidine-alcohol group vs 7.5% [121/1621] in the povidone-iodine-alcohol group; risk difference, 0.25 [95% confidence interval (CI), - 1.58-2.07], P = 0.79). The incidence of surgical site infections at the sternum or peripheral sites was similar (4% [65/1621] in the chlorhexidine-alcohol group vs 3.3% [53/1621] in the povidone-iodine-alcohol group; risk difference, 0.74 [95% CI - 0.55-2.03], P = 0.26). Length of hospital stay, intensive care unit or hospital readmission, mortality and surgical site adverse events were similar between the two groups.ConclusionAmong patients requiring sternotomy for major heart or aortic surgery, skin disinfection at the surgical site using chlorhexidine-alcohol was not superior to povidone-iodine-alcohol for reducing reoperation and surgical site infection rates.
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页码:2114 / 2124
页数:11
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