Evidence map›Paper›PMID 37604635›Full record

ArticleBMJ open2023

Effect of aqueous olanexidine versus alcohol-based chlorhexidine for surgical skin antisepsis on incidence of surgical site infections in gastrointestinal surgery: multicentre randomised controlled clinical trial (OEDO trial) protocol.

Masashi Takeuchi, Hideaki Obara, Tasuku Furube, Hirofumi Kawakubo, Minoru Kitago, Koji Okabayashi, Junya Aoyama, Ryusuke Amemiya, Hiroto Fujisaki, Junichi Sano and 3 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 24% of its field
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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. 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

13 authors at 4 institutions in 1 country.

Masashi TakeuchiDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.
Hideaki ObaraDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan obara.z3@keio.jp.ORCID 0000-0001-6740-2715
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.
Junya AoyamaDepartment of Gastrointestinal Surgery, Saiseikai Yokohamashi Tobu Hospital, Kanagawa, Japan.
Ryusuke AmemiyaDepartment of Surgery, Kawasaki Municipal Hospital, Kanagawa, Japan.
Hiroto FujisakiDepartment of Surgery, Hiratsuka City Hospital, Kanagawa, Japan.
Junichi SanoDepartment of Gastrointestinal Surgery, Saitama City Hospital, Saitama, Japan.
Rei GotoGraduate School of Business Administration, Keio University, Tokyo, Japan.
Yasunori SatoDepartment of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.
Yuko KitagawaDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.
Keio University · JPHiratsuka City Hospital · JPKawasaki Municipal Hospital · JPSaitama Municipal Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSurgical site infections (SSIs) are among the most common nosocomial infections in surgery patients. Two types of preparations, povidone-iodine and chlorhexidine-alcohol, are commonly used in preoperative antiseptic procedures worldwide. However, there are inconsistencies among international guideline recommendations concerning skin antiseptics. This trial aimed to evaluate the superiority of olanexidine, which reduced SSI rates more than povidone-iodine in our previous randomised trial, over chlorhexidine-alcohol in clean-contaminated surgery. METHODS AND ANALYSIS: This multicentre randomised controlled clinical trial will compare two antiseptics (1.5% olanexidine and 1.0% chlorhexidine-alcohol) to prevent SSI in clean-contaminated gastrointestinal surgeries with surgical wounds. On providing consent, patients aged <18 years will be included. The primary outcome will be the postoperative 30-day overall SSI rate, while the secondary outcomes will be the postoperative 30-day superficial incisional SSI rate, deep incisional SSI rate, organ/space SSI rate, positive bacterial wound culture rate, cultured bacterial strains, rates of intervention-related toxicity and allergic events (eg, erythema, pruritus, dermatitis and other symptoms of allergy around the region disinfected by the antiseptic during surgery), rate of reoperations due to SSI, medical economic effect indicators (based on health insurance claims) and hospital duration. The Mantel-Haenszel method will be used to estimate the adjusted risk ratio and its 95% CI for the primary analysis, which will compare the treatment effects. ETHICS AND DISSEMINATION: The protocol was approved by the Institutional Review Board of Keio University School of Medicine and subsequently by the board of each participating site. Participant recruitment began in January 2023. The final results will be published in medical journals after international peer review. TRIAL REGISTRATION NUMBER: UMIN000049712.

Indexed as

Anti-Infective Agents, LocalDigestive System Surgical ProceduresHypersensitivityAntisepsisBiguanidesChlorhexidineEquivalence Trials as TopicEthanolHumansIncidenceMulticenter Studies as TopicPovidone-IodineRandomized Controlled Trials as TopicSurgical Wound InfectionAnti-Infective Agents, LocalBiguanidesChlorhexidineEthanololanexidinePovidone-Iodineadult surgeryclinical trialinfection control

Identifiers

PMID37604635
PMCPMC10445365
OpenAlexW4386034809

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.