Evidence map›Paper›PMID 40156892›Full record

ArticleThe British journal of surgery2025

Efficacy of aqueous olanexidine compared with alcohol-based chlorhexidine for surgical skin antisepsis regarding the incidence of surgical-site infections in clean-contaminated surgery: a randomized superiority trial.

Masashi Takeuchi, Hideaki Obara, Tasuku Furube, Hirofumi Kawakubo, Minoru Kitago, Koji Okabayashi, Hiroto Fujisaki, Junya Aoyama, Yosuke Morimoto, Ryusuke Amemiya and 5 more

Abstract readComparative StudyEquivalence TrialMulticenter Study
In one paragraph

Article in The British journal of surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Masashi TakeuchiDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.
Hideaki ObaraDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.
Tasuku FurubeDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.
Hirofumi KawakuboDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.
Minoru KitagoDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.
Koji OkabayashiDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.ORCID 0000-0001-8554-1137
Hiroto FujisakiDepartment of Surgery, Hiratsuka City Hospital, Kanagawa, Japan.
Junya AoyamaDepartment of Surgery, Saiseikai Yokohamashi Tobu Hospital, Kanagawa, Japan.
Yosuke MorimotoDepartment of Surgery, Saiseikai Yokohamashi Tobu Hospital, Kanagawa, Japan.
Ryusuke AmemiyaDepartment of Surgery, Kawasaki Municipal Hospital, Kanagawa, Japan.
Junichi SanoDepartment of Gastrointestinal Surgery, Saitama City Hospital, Saitama, Japan.
Jumpei NakadaiDepartment of Gastrointestinal Surgery, Saitama City Hospital, Saitama, Japan.
Rei GotoGraduate School of Business Administration, Keio University, Yokohama, Japan.ORCID 0000-0002-7484-4957
Yasunori SatoDepartment of Biostatistics, Keio University School of Medicine, Tokyo, Japan.
Yuko KitagawaDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.

Funding

Department of Surgery, Keio University School of Medicine
6 · The paper itself

Abstract

backgroundSurgical-site antisepsis is used to prevent surgical-site infections (SSIs). Although several guidelines have indicated the efficacy of antiseptics, such as chlorhexidine, povidone-iodine, and olanexidine, in reducing the SSI rate, an optimal recommendation is still not established. The aim of this study was to evaluate the efficacy of aqueous olanexidine compared with chlorhexidine-alcohol as the optimal antiseptic for preventing SSI in clean-contaminated surgery.

methodsThis multicentre randomized trial for surgical skin antisepsis in clean-contaminated gastrointestinal and hepatobiliary-pancreatic surgeries in five hospitals evaluated the efficacy of olanexidine and chlorhexidine-alcohol. The primary endpoint was 30-day SSI. Secondary outcomes included the occurrence of SSI types, intervention-related toxicity, and reoperation caused by SSI.

resultsOverall, 700 patients from five institutions underwent randomization; 347 received olanexidine and 345 received chlorhexidine-alcohol in the full analysis set. The 30-day SSI rate was 12.4% (43 of 347) in the olanexidine group and 13.6% (47 of 345) in the chlorhexidine-alcohol group (adjusted risk ratio (aRR) 0.911 (95% c.i. 0.625 to 1.327); P = 0.626). No significant differences were observed between the groups regarding the secondary outcomes, including the occurrence of superficial incisional SSI, deep incisional SSI, organ/space SSI, and reoperation caused by SSI. Overall adverse effects were seen in two patients (0.58%) in the olanexidine group and in three patients (0.87%) in the chlorhexidine-alcohol group (aRR 0.663 (95% c.i. 0.111 to 3.951)).

conclusionOlanexidine did not significantly reduce the occurrence of overall SSI compared with chlorhexidine-alcohol. Nevertheless, these findings provide valuable insights for developing novel surgical SSI management protocols. REGISTRATION NUMBER: UMIN 000049712 (University Hospital Medical Information Network Clinical Trials Registry).

Indexed as

Anti-Infective Agents, LocalAntisepsisBiguanidesChlorhexidineEthanolSurgical Wound InfectionAdultAgedFemaleHumansIncidenceMaleMiddle AgedTreatment OutcomeAnti-Infective Agents, LocalBiguanidesChlorhexidineEthanol

Identifiers

PMID40156892
PMCPMC12475902

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.