Comparison of the efficacy of three topical antiseptic solutions for the prevention of catheter colonization: a multicenter randomized controlled study
Hideto Yasuda,
Masamitsu Sanui,
Takayuki Abe,
Nobuaki Shime,
Tetsuya Komuro,
Junji Hatakeyama,
Shohei Matsukubo,
Shinji Kawano,
Hiroshi Yamamoto,
Kohkichi Andoh,
Ryutaro Seo,
Kyo Inoue,
Eiichiro Noda,
Nobuyuki Saito,
Satoshi Nogami,
Kentaro Okamoto,
Ryota Fuke,
Yasuhiro Gushima,
Atsuko Kobayashi,
Toru Takebayashi,
Alan Kawarai Lefor,
for Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group
Affiliations
Hideto Yasuda
Intensive Care Unit, Department of Emergency and Critical Care Medicine, Japanese Red Cross Musashino Hospital
Masamitsu Sanui
Department of Anesthesiology and Critical Care Medicine, Jichi Medical University Saitama Medical Center
Takayuki Abe
Department of Preventive Medicine and Public Health, Keio University School of Medicine
Nobuaki Shime
Department of Emergency and Critical Care Medicine, Hiroshima University
Tetsuya Komuro
Department of Anesthesiology and Critical Care Medicine, Jichi Medical University Saitama Medical Center
Junji Hatakeyama
Department of Intensive Care Medicine, Yokohama City Minato Red Cross Hospital
Shohei Matsukubo
Department of Emergency Medicine, Emergency and Critical Care Center, Kurashiki Central Hospital
Shinji Kawano
Intensive Care Unit, Department of Anesthesiology, Jikei University School of Medicine
Hiroshi Yamamoto
Department of Anesthesia, Toyonaka Municipal Hospital
Kohkichi Andoh
Emergency and Critical Care Department, Division of Intensive Care, Sendai City Hospital
Ryutaro Seo
Department of Emergency Medicine, Kobe City Medical Center General Hospital
Kyo Inoue
Department of Emergency and Critical Care Medicine, National Hospital Organization Kyoto Medical Center
Eiichiro Noda
Department of Emergency Medicine, Fukuoka City Hospital
Nobuyuki Saito
Shock and Trauma Center, Chiba-Hokusoh Hospital, Nippon Medical School
Satoshi Nogami
Department of Anesthesiology, Okayama Medical Center
Kentaro Okamoto
Department of Intensive Care Medicine, Tokyo Bay Urayasu Ichikawa Medical Center
Ryota Fuke
Division of Infectious Diseases and Infection Control, Tohoku Medical and Pharmaceutical University Hospital
Yasuhiro Gushima
Department of Acute Care and General Medicine, Saiseikai Kumamoto Hospital
Atsuko Kobayashi
Department of Central Laboratory and Infection Control, Takarazuka City Hospital
Toru Takebayashi
Department of Preventive Medicine and Public Health, Keio University School of Medicine
Alan Kawarai Lefor
Department of Surgery, Jichi Medical University
for Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group
Abstract Background To compare the efficacy of three antiseptic solutions [0.5%, and 1.0% alcohol/chlorhexidine gluconate (CHG), and 10% aqueous povidone-iodine (PVI)] for the prevention of intravascular catheter colonization, we conducted a randomized controlled trial in patients from 16 intensive care units in Japan. Methods Adult patients undergoing central venous or arterial catheter insertions were randomized to have one of three antiseptic solutions applied during catheter insertion and dressing changes. The primary endpoint was the incidence of catheter colonization, and the secondary endpoint was the incidence of catheter-related bloodstream infections (CRBSI). Results Of 1132 catheters randomized, 796 (70%) were included in the full analysis set. Catheter-tip colonization incidence was 3.7, 3.9, and 10.5 events per 1000 catheter-days in 0.5% CHG, 1% CHG, and PVI groups, respectively (p = 0.03). Pairwise comparisons of catheter colonization between groups showed a significantly higher catheter colonization risk in the PVI group (0.5% CHG vs. PVI: hazard ratio, HR 0.33 [95% confidence interval, CI 0.12–0.95], p = 0.04; 1.0% CHG vs. PVI: HR 0.35 [95% CI 0.13–0.93], p = 0.04). Sensitivity analyses including all patients by multiple imputations showed consistent quantitative conclusions (0.5% CHG vs. PVI: HR 0.34, p = 0.03; 1.0% CHG vs. PVI: HR 0.35, p = 0.04). No significant differences were observed in the incidence of CRBSI between groups. Conclusions Both 0.5% and 1.0% alcohol CHG are superior to 10% aqueous PVI for the prevention of intravascular catheter colonization. Trial registration Japanese Primary Registries Network; No.: UMIN000008725 Registered on 1 September 2012