Evidence map›Paper›PMID 36328372›Full record

Trial reportBMJ (Clinical research ed.)2022

Effect of oral antimicrobial prophylaxis on surgical site infection after elective colorectal surgery: multicentre, randomised, double blind, placebo controlled trial.

Emmanuel Futier, Samir Jaber, Matthias Garot, Marie Vignaud, Yves Panis, Karem Slim, Jean-Christophe Lucet, Gilles Lebuffe, Alexandre Ouattara, Younes El Amine and 9 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02618720 (Intravenous Versus Combined Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Elective Colorectal Surgery), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
7.8field-weighted citation impact, top 2% 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.

NCT02618720 phase3completednot on this map

Intravenous Versus Combined Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Elective Colorectal Surgery: A Double-blinded Multicenter Prospective Randomized Controlled Trial

TypeinterventionalSponsorUniversity Hospital, Clermont-FerrandRan2016 to 2020Enrolled920ConditionsElective Colorectal SurgeryArmsornidazole, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
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  10. Wound Microbiota and Its Impact on Wound Healing.International journal of molecular sciences · 2023
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 13 institutions in 1 country.

Emmanuel FutierDépartement Anesthésie et Réanimation, Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Estaing, Clermont-Ferrand, France efutier@chu-clermontferrand.fr.ORCID 0000-0002-6454-271X
Samir JaberDépartement Anesthésie et Réanimation B, Centre Hospitalier Universitaire de Montpellier, Hôpital Saint-Eloi, Montpellier, France.
Matthias GarotPôle Anesthésie Réanimation, Centre Hospitalier Universitaire de Lille, Hôpital Claude Huriez, Lille, France.
Marie VignaudDépartement Anesthésie et Réanimation, Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Estaing, Clermont-Ferrand, France.
Yves PanisDépartement de Chirurgie Colorectale, Assistance publique-Hôpitaux de Paris, Pôle des Maladies de l'Appareil Digestif, Hôpital Beaujon, Clichy, France.
Karem SlimService de Chirurgie Digestive et Hépatobiliaire, Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Estaing, Clermont-Ferrand, France.
Jean-Christophe LucetUnité d'Hygiène et de Lutte Contre les Infections Nosocomiales, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat-Claude Bernard, Paris, France.
Gilles LebuffePôle Anesthésie Réanimation, Centre Hospitalier Universitaire de Lille, Hôpital Claude Huriez, Lille, France.
Alexandre OuattaraService Anesthésie et Réanimation, Centre Medico-chirurgical Magellan, Centre Hospitalier Universitaire de Bordeaux, Pessac, France.
Younes El AmineDépartement Anesthésie et Réanimation, Centre Hospitalier de Valenciennes, Valenciennes, France.
Philippe CoudercService de Chirurgie Viscérale et Digestive, Centre Hospitalier de Pau, Pau, France.
Aurélien DupréDépartement de chirurgie oncologique, Centre Léon Bérard, Lyon, France.
Audrey De JongDépartement Anesthésie et Réanimation B, Centre Hospitalier Universitaire de Montpellier, Hôpital Saint-Eloi, Montpellier, France.
Sigismond LasockiDépartement Anesthésie et Réanimation, Centre Hospitalier Universitaire de Angers, Angers, France.
Marc LeoneService Anesthésie et Réanimation, Assistance Publique Hôpitaux de Marseille, Aix Marseille Université, Hôpital Nord, Marseille, France.
Julien PottecherService d'Anesthésie Réanimation et Médecine Périopératoire, Hôpitaux Universitaires de Strasbourg, Hôpital Hautepierre, Strasbourg, France.
Bruno PereiraDirection de la Recherche Clinique, Centre Hospitalier Universitaire de Clermont-Ferrand, Biostatistics Unit, Clermont-Ferrand, France.
Catherine Paugam-BurtzDépartement Anesthésie Réanimation, Assistance publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris Nord Val de Seine, Hôpital Beaujon, Clichy, France.
COMBINE study group
Centre Hospitalier Universitaire de Clermont-Ferrand · FRHôpital Beaujon · FRInserm · FRUniversité Claude Bernard Lyon 1 · FRAix-Marseille Université · FRCentre Hospitalier De Pau · FRCentre Hospitalier de Valenciennes · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Lille · FRCentre National de la Recherche Scientifique · FRHôpitaux Universitaires de Strasbourg · FRUniversité de Bordeaux · FRUniversité de Lille · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate whether oral antimicrobial prophylaxis as an adjunct to intravenous antibiotic prophylaxis reduces surgical site infections after elective colorectal surgery.

designMulticentre, randomised, double blind, placebo controlled trial.

setting11 university and non-university hospitals in France between 25 May 2016 and 8 August 2019.

participants926 adults scheduled for elective colorectal surgery.

interventionPatients were randomised to receive either a single 1 g dose of ornidazole (n=463) or placebo (n=463) orally 12 hours before surgery, in addition to intravenous antimicrobial prophylaxis before surgical incision.

main outcome measuresThe primary outcome was the proportion of patients with surgical site infection within 30 days after surgery. Secondary outcomes included individual types of surgical site infections and major postoperative complications (Clavien-Dindo classification grade 3 or higher) within 30 days after surgery.

resultsOf the 960 patients who were enrolled, 926 (96%) were included in the analysis. The mean age of participants was 63 years and 554 (60%) were men. Surgical site infection within 30 days after surgery occurred in 60 of 463 patients (13%) in the oral prophylaxis group and 100 of 463 (22%) in the placebo group (absolute difference -8.6%, 95% confidence interval -13.5% to -3.8%; relative risk 0.60, 95% confidence interval 0.45 to 0.80). The proportion of patients with deep infections was 4.8% in the oral prophylaxis group and 8.0% in the placebo group (absolute difference -3.2%, 95% confidence interval -6.4% to -0.1%). The proportion of patients with organ space infections was 5.0% in the oral prophylaxis group and 8.4% in the placebo group (absolute difference -3.4%, -6.7% to -0.2%). Major postoperative complications occurred in 9.1% patients in the oral prophylaxis group and 13.6% in the placebo group (absolute difference -4.5%, -8.6% to -0.5%).

conclusionAmong adults undergoing elective colorectal surgery, the addition of a single 1 g dose of ornidazole compared with placebo before surgery significantly reduced surgical site infections.

trial registrationClinicalTrials.gov NCT02618720.

Indexed as

Anti-Infective AgentsColorectal SurgeryOrnidazoleAdultAnti-Bacterial AgentsAntibiotic ProphylaxisDouble-Blind MethodFemaleHumansMaleMiddle AgedSurgical Wound InfectionAnti-Bacterial AgentsAnti-Infective AgentsOrnidazole

Identifiers

PMID36328372
PMCPMC9631300
OpenAlexW4308190689

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.