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Randomized Controlled Trial
. 2017 Dec 21;21(1):320.
doi: 10.1186/s13054-017-1890-z.

Comparison of the efficacy of three topical antiseptic solutions for the prevention of catheter colonization: a multicenter randomized controlled study

Hideto Yasuda  1   2   3 , Masamitsu Sanui  4 , Takayuki Abe  3   5 , Nobuaki Shime  6 , Tetsuya Komuro  7 , Junji Hatakeyama  8 , Shohei Matsukubo  9 , Shinji Kawano  10 , Hiroshi Yamamoto  11 , Kohkichi Andoh  12 , Ryutaro Seo  13 , Kyo Inoue  14 , Eiichiro Noda  15 , Nobuyuki Saito  16 , Satoshi Nogami  17 , Kentaro Okamoto  18 , Ryota Fuke  19 , Yasuhiro Gushima  20 , Atsuko Kobayashi  21 , Toru Takebayashi  3 , Alan Kawarai Lefor  22 ; for Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group
Affiliations
Randomized Controlled Trial

Comparison of the efficacy of three topical antiseptic solutions for the prevention of catheter colonization: a multicenter randomized controlled study

Hideto Yasuda et al. Crit Care. .

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.

Keywords: Anti-bacterial agents; Anti-infective agents; Catheter-related infections; Catheters; Chlorhexidine; Local; Povidone-iodine.

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Conflict of interest statement

Ethics approval and consent to participate

The review boards of all participating institutions approved the study protocol, and patients/close relatives provided written informed consent. The specific names of all ethical bodies that approved this study in various participating sites involved in Additional file 1: Table S15.

Consent for publication

Not applicable

Competing interests

HY received lecture fees from Maruishi Pharmaceutical Company. MS received lecture fees from Maruishi Pharmaceutical Company. All other authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart showing randomization of skin preparation for catheter insertion. CHG chlorhexidine gluconate, FAS full analysis set, ITT Intention to treat, PVI povidone-iodine
Fig. 2
Fig. 2
Cumulative catheter colonization and catheter-related bloodstream infection risk (Kaplan–Meier curves). a catheter colonization, b catheter-related bloodstream infection. CHG chlorhexidine gluconate, PVI povidone-iodine
See this image and copyright information in PMC

References

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