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

Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group, Takayuki Abe

Research output: Contribution to journalArticle

4 Citations (Scopus)

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

Original languageEnglish
Article number320
JournalCritical Care
Volume21
Issue number1
DOIs
Publication statusPublished - 2017 Dec 21

Fingerprint

Local Anti-Infective Agents
Povidone-Iodine
Catheters
Catheter-Related Infections
Incidence
Alcohols
chlorhexidine gluconate
Bandages
Intensive Care Units
Registries
Japan
Randomized Controlled Trials
Confidence Intervals

Keywords

  • Anti-bacterial agents
  • Anti-infective agents
  • Catheter-related infections
  • Catheters
  • Chlorhexidine
  • Local
  • Povidone-iodine

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

Cite this

Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group, & Abe, T. (2017). Comparison of the efficacy of three topical antiseptic solutions for the prevention of catheter colonization: A multicenter randomized controlled study. Critical Care, 21(1), [320]. https://doi.org/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. / Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group; Abe, Takayuki.

In: Critical Care, Vol. 21, No. 1, 320, 21.12.2017.

Research output: Contribution to journalArticle

Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group & Abe, T 2017, 'Comparison of the efficacy of three topical antiseptic solutions for the prevention of catheter colonization: A multicenter randomized controlled study', Critical Care, vol. 21, no. 1, 320. https://doi.org/10.1186/s13054-017-1890-z
Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group, Abe T. Comparison of the efficacy of three topical antiseptic solutions for the prevention of catheter colonization: A multicenter randomized controlled study. Critical Care. 2017 Dec 21;21(1). 320. https://doi.org/10.1186/s13054-017-1890-z
Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group ; Abe, Takayuki. / Comparison of the efficacy of three topical antiseptic solutions for the prevention of catheter colonization : A multicenter randomized controlled study. In: Critical Care. 2017 ; Vol. 21, No. 1.
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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",
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T1 - Comparison of the efficacy of three topical antiseptic solutions for the prevention of catheter colonization

T2 - A multicenter randomized controlled study

AU - Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group

AU - Yasuda, Hideto

AU - Abe, Takayuki

AU - Abe, Takayuki

AU - Shime, Nobuaki

AU - Komuro, Tetsuya

AU - Hatakeyama, Junji

AU - Matsukubo, Shohei

AU - Kawano, Shinji

AU - Yamamoto, Hiroshi

AU - Andoh, Kohkichi

AU - Seo, Ryutaro

AU - Inoue, Kyo

AU - Noda, Eiichiro

AU - Saito, Nobuyuki

AU - Nogami, Satoshi

AU - Okamoto, Kentaro

AU - Fuke, Ryota

AU - Gushima, Yasuhiro

AU - Kobayashi, Atsuko

AU - Takebayashi, Toru

AU - Lefor, Alan Kawarai

PY - 2017/12/21

Y1 - 2017/12/21

N2 - 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

AB - 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

KW - Anti-bacterial agents

KW - Anti-infective agents

KW - Catheter-related infections

KW - Catheters

KW - Chlorhexidine

KW - Local

KW - Povidone-iodine

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