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BMJ Open. 2018 Apr 12;8(4):e020254. doi: 10.1136/bmjopen-2017-020254.

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.

Author information

1
Département Anesthésie et Réanimation, Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Estaing, Clermont-Ferrand, France.
2
Assistance publique-Hôpitaux de Paris (AP-HP), Département Anesthésie Réanimation, Hôpital Beaujon, Hôpitaux Universitaires Paris Nord Val de Seine, Paris, France.
3
Pôle Anesthesie Réanimation, Centre Hospitalier Universitaire (CHU) Lille, Lille, France.
4
Département Anesthesie Réanimation B (DAR B), Centre Hospitalier Regional Universitaire de Montpellier, Hôpital Saint-Eloi, and Inserm U-1046, Montpellier, France.
5
Service de Chirurgie Digestive, Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Estaing, CLERMONT-FERRAND, France.
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
Direction de la Recherche Clinique & Innovation (DRCI), Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.
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
Unité de Biostatistiques, Direction de la Recherche Clinique & Innovations (DRCI), Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.
10
GreD, CNRS, Inserm U1103, Université Clermont Auvergne, Clermont-Ferrand, France.

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.

KEYWORDS:

clinical trials; colorectal surgery

Conflict of interest statement

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.

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