Evidence map›Paper›PMID 39531051›Full record

Trial reportIntensive care medicine2024

Chlorhexidine-alcohol compared with povidone-iodine-alcohol skin antisepsis protocols in major cardiac surgery: a randomized clinical trial.

Matthieu Boisson, Géraldine Allain, Jean-Christian Roussel, Nicolas d'Ostrevy, Silvia Burbassi, Pierre Demondion, Paul-Michel Mertes, François Labaste, Thomas Kerforne, Bertrand Rozec and 12 more

Abstract readRandomized Controlled TrialMulticenter StudyComparative Study
In one paragraph

Trial report in Intensive care medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Review
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

22 authors.

Matthieu BoissonINSERM U1070 PHAR2, CHU de Poitiers, Service d'Anesthésie-Réanimation et Médecine Péri-Opératoire, Université de Poitiers, Poitiers Cedex, France. matthieu.boisson@chu-poitiers.fr.ORCID 0000-0003-3667-5782
Géraldine AllainINSERM U1313 IRMETIST, CHU de Poitiers, Service de Chirurgie Cardio-Thoracique et Vasculaire, Université de Poitiers, Poitiers, France.
Jean-Christian RousselService de chirurgie cardio-thoracique, Hôpital G et R Laennec, CHU Nantes, Nantes Université, Nantes, France.
Nicolas d'OstrevyService de Chirurgie Cardio-Vasculaire, CHU de Clermont-Ferrand, Clermont-Ferrand, France.
Silvia BurbassiUnité de Recherche Clinique, Institut Mutualiste Montsouris, Paris, France.
Pierre DemondionINSERM, UMRS_1166-ICAN, Institute of Cardiometabolism and Nutrition, Department of Thoracic and Cardiovascular Surgery, Cardiology Institute, AP-HP, Sorbonne Université, Paris, France.
Paul-Michel MertesPôle d'Anesthésie Réanimation et Médecine Périopératoire, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Strasbourg, France.
François LabasteINSERM RESTAURE UMR 1301-5070 CNRS, Service d'Anesthésie-Réanimation et Médecine Péri-Opératoire, CHU de Toulouse, Université de Toulouse 3, Toulouse, France.
Thomas KerforneINSERM U1313 IRMETIST, CHU de Poitiers, Service d'Anesthésie-Réanimation et Médecine Péri-Opératoire, Université de Poitiers, Poitiers, France.
Bertrand RozecCNRS, INSERM, l'institut du thorax, Service d'Anesthésie et de Réanimation, Hôpital G et R Laennec, CHU Nantes, Nantes Université, Nantes, France.
Vedat EljeziUniversité Clermont Auvergne, CHU Gabriel Montpied, Pôle Médecine Péri-Opératoire, Clermont Ferrand, France.
Konstantinos ZannisService de chirurgie cardiaque, Institut Mutualiste Montsouris, Paris, France.
Pascal LeprinceINSERM, UMRS_1166-ICAN, Institute of Cardiometabolism and Nutrition, Department of Thoracic and Cardiovascular Surgery, Cardiology Institute, AP-HP, Sorbonne Université, Paris, France.
Walid OulehriPôle d'Anesthésie Réanimation et Médecine Périopératoire, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
Vincent MinvilleINSERM RESTAURE UMR 1301-5070 CNRS, Service d'Anesthésie-Réanimation et Médecine Péri-Opératoire, CHU de Toulouse, Université de Toulouse 3, Toulouse, France.
Sabrina SeguinService d'Anesthésie-Réanimation et Médecine Péri-Opératoire, CHU de Poitiers, Poitiers, France.
Ambre LoiodiceICURESEARCH, Fontaine, France.
Stéphane RucklyDepartment of Biostatistics, OUTCOME REA Research Network, Drancy, France.
Jean-Christophe LucetINSERM, IAME, U1137, Team DeSCID, Infection Control Unit, Bichat Claude Bernard Hospital, AP-HP, Paris, France.
Jean-François TimsitINSERM, IAME, U1137, Team DeSCID, Medical and infectious diseases ICU (MI2), Bichat Claude Bernard Hospital, AP-HP, Université Paris-Cité, Paris, France.
Olivier MimozINSERM U1070 PHAR2, CHU de Poitiers, Université de Poitiers, Service des Urgences Adultes-SAMU 86 Centre 15, Poitiers, France.
CLEAN 2 Study Group

Funding

Ministère de la Santé - Programme Hospitalier de Recherche Clinique 16-0619
6 · The paper itself

Abstract

purposeWhether skin disinfection of the surgical site using chlorhexidine-alcohol is superior to povidone-iodine-alcohol in reducing reoperation and surgical site infection rates after major cardiac surgery remains unclear.

methodsCLEAN 2 was a multicenter, open-label, randomized, two-arm, assessor-blind, superiority trial conducted in eight French hospitals. We randomly assigned adult patients undergoing major heart or aortic surgery via sternotomy, with or without saphenous vein or radial artery harvesting, to have all surgical sites disinfected with either 2% chlorhexidine-alcohol or 5% povidone-iodine-alcohol. The primary outcome was any resternotomy by day 90 or any reoperation at the peripheral surgical site by day 30.

resultsOf 3242 patients (1621 in the chlorhexidine-alcohol group [median age, 69 years; 1276 (78.7%) men] and 1621 in the povidone-iodine-alcohol group [median age, 69 years; 1247 (76.9%) men], the percentage required reoperation within 90 days was similar (7.7% [125/1621] in the chlorhexidine-alcohol group vs 7.5% [121/1621] in the povidone-iodine-alcohol group; risk difference, 0.25 [95% confidence interval (CI), - 1.58-2.07], P = 0.79). The incidence of surgical site infections at the sternum or peripheral sites was similar (4% [65/1621] in the chlorhexidine-alcohol group vs 3.3% [53/1621] in the povidone-iodine-alcohol group; risk difference, 0.74 [95% CI - 0.55-2.03], P = 0.26). Length of hospital stay, intensive care unit or hospital readmission, mortality and surgical site adverse events were similar between the two groups.

conclusionAmong patients requiring sternotomy for major heart or aortic surgery, skin disinfection at the surgical site using chlorhexidine-alcohol was not superior to povidone-iodine-alcohol for reducing reoperation and surgical site infection rates.

Indexed as

Anti-Infective Agents, LocalCardiac Surgical ProceduresChlorhexidinePovidone-IodineSurgical Wound InfectionAgedAntisepsisEthanolFemaleHumansMaleMiddle AgedReoperationAnti-Infective Agents, LocalChlorhexidineEthanolPovidone-IodineCardiac surgeryChlorhexidinePovidone iodineSkin antisepsisSurgical site infection

Identifiers

PMID39531051
PMCPMC11588771

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.