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Surgery
Protocol
Comparison of intravenous versus combined oral and intravenous antimicrobial prophylaxis (COMBINE) for the prevention of surgical site infection in elective colorectal surgery: study protocol for a multicentre, double-blind, randomised controlled clinical trial
  1. Marie Vignaud1,
  2. Catherine Paugam-Burtz2,
  3. Matthias Garot3,
  4. Samir Jaber4,
  5. Karem Slim5,
  6. Yves Panis6,
  7. Jean-Christophe Lucet7,
  8. Justine Bourdier8,
  9. Dominique Morand8,
  10. Bruno Pereira9,
  11. Emmanuel Futier1,10
  12. on behalf of the COMBINE trial management committee
  1. 1 Département Anesthésie et Réanimation, Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Estaing, Clermont-Ferrand, France
  2. 2 Assistance publique-Hôpitaux de Paris (AP-HP), Département Anesthésie Réanimation, Hôpital Beaujon, Hôpitaux Universitaires Paris Nord Val de Seine, Paris, France
  3. 3 Pôle Anesthesie Réanimation, Centre Hospitalier Universitaire (CHU) Lille, Lille, France
  4. 4 Département Anesthesie Réanimation B (DAR B), Centre Hospitalier Regional Universitaire de Montpellier, Hôpital Saint-Eloi, and Inserm U-1046, Montpellier, France
  5. 5 Service de Chirurgie Digestive, Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Estaing, CLERMONT-FERRAND, France
  6. 6 Unité d’Hygiène et de Lutte contre l’Infection Nosocomiale, Assistance publique-Hôpitaux de Paris (AP-HP), Hôpital Bichat-Claude Bernard, Paris, France
  7. 7 Direction de la Recherche Clinique & Innovation (DRCI), Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
  8. 8 Departement de Chirurgie Colorectale, Assistance publique-Hôpitaux de Paris (AP-HP), Pôle des Maladies de l’Appareil Digestif (PMAD), Hôpital Beaujon, Clichy, France
  9. 9 Unité de Biostatistiques, Direction de la Recherche Clinique & Innovations (DRCI), Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
  10. 10 GreD, CNRS, Inserm U1103, Université Clermont Auvergne, Clermont-Ferrand, France
  1. Correspondence to Professor Emmanuel Futier; efutier{at}chu-clermontferrand.fr

Abstract

Introduction Surgical site infections (SSIs) account for 30% of all healthcare-associated infections, with reported rates ranging from 8% and 30% after colorectal surgery and are associated with increased morbidity and mortality rates, length of hospital stay and costs in healthcare. Administration of systemic antimicrobial prophylaxis before surgery is recommended to reduce the risk of SSI, but the optimal regimen remains unclear. We aim to evaluate whether a combined oral and intravenous antimicrobial prophylaxis could be more effective to reduce the incidence of SSI after colorectal surgery, as compared with the standard practice of intravenous antimicrobial prophylaxis alone.

Methods and analysis Comparison of intravenous versus combined oral and intravenous antimicrobial prophylaxis (COMBINE) trial is a randomised, placebo-controlled, parallel, double-blind, multicentre study of 960 patients undergoing elective colorectal surgery. Patients will be randomly allocated in a 1:1 ratio to receive either combined oral and intravenous antimicrobial prophylaxis or intravenous antibiotic prophylaxis alone, stratified by centre, the surgical procedure (laparoscopic or open surgery) and according to the surgical skin antisepsis (chlorexidine–alcohol or povidione-iodine alcoholic solution). The primary endpoint is the rate of SSI by day 30 following surgery, with SSI defined by the criteria developed by the Centers for Disease Control and Prevention. Data will be analysed on the intention-to-treat principle and a per-protocol basis.

Ethics and dissemination COMBINE trial has been approved by an independent ethics committee for all study centres. Participant recruitment began in May 2016. Results will be published in international peer-reviewed medical journals.

Trial registration number EudraCT 2015-002559-84; NCT02618720.

  • colorectal surgery
  • clinical trials

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-020254

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    Footnotes

    • Contributors CP-B, KS, SJ, J-CL, YP and EF are members of COMBINE trial scientific committee and contributed to the conception and design of the research protocol. MV and MG provided critical input pertaining to the design of the trial interventions and procedures. MV and JB wrote the first draft of the protocol and this manuscript. BP and DM designed the statistical analysis plan. All authors critically revised the protocol for intellectual content and approved the final version to be published.

    • Funding COMBINE trial is supported by funding from French Ministry of Health (Programme Hospitalier de Recherché Clinique (PHRC) National 2014) and from the University Hospital of Clermont-Ferrand.

    • Disclaimer The funding sources had no role in the trial design, trial conduct, data handling, data analysis or writing and publication of the manuscript.

    • Competing interests EF reports personal fees from Drager, personal fees from Edwards Lifesciences, personal fees from General Electric Healthcare, personal fees from Fresenius Kabi, personal fees from Fisher and Paykel Healthcare, outside the submitted work.

    • Patient consent Obtained.

    • Ethics approval By 3 July 2015, the study has been approved for all centres by a central ethics committee (Comité de Protection des Personnes Sud-Est VI, Clermont-Ferrand, France) (ref: AU1204).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Ownership of the data arising from this trial resides with the trial research team. On completion of the trial, the trial data will be analysed and a clinical trial report will be prepared.