Abstract
Standard bolus-dosed antibiotic prophylaxis may not inhibit growth of antibiotic resistant colonic bacteria, a cause of SSIs after colorectal surgery. An alternative strategy is continuous administration of antibiotic throughout surgery, maintaining concentrations of antibiotics that inhibit growth of resistant bacteria. This study is a pilot comparing bolus-continuous infusion with bolus-dosed cefuroxime prophylaxis in colorectal surgery. This is a pilot randomised controlled trial in which participants received cefuroxime bolus-infusion (intervention arm) targeting free serum cefuroxime concentrations of 64 mg/L, or 1.5 g cefuroxime as a bolus dose four-hourly (standard arm). Patients in both arms received metronidazole (500 mg intravenously). Eligible participants were adults undergoing colorectal surgery expected to last for over 2 h. Results were analysed on an intention-to-treat basis. The study was successfully piloted, with 46% (90/196) of eligible patients recruited and 89% (80/90) of participants completing all components of the protocol. A trialled bolus-continuous dosing regimen was successful in maintaining free serum cefuroxime concentrations of 64 mg/L. No serious adverse reactions were identified. Rates of SSIs (superficial and deep SSIs) were lower in the intervention arm than the standard treatment arm (24% (10/42) vs. 30% (13/43)), as were infection within 30 days of operation (41% (17/43) vs 51% (22/43)) and urinary tract infections (2% (1/42) vs. 9% (4/43)). These infection rates can be used to power future clinical trials. This study demonstrates the feasibility of cefuroxime bolus-continuous infusion of antibiotic prophylaxis trials, and provides safety data for infusions targeting free serum cefuroxime concentrations of 64 mg/L. Trial registration: NCT02445859.
Highlights
Colorectal surgery is a common procedure, with approximately 100,000 operations annually within England, with 18–27% developing a surgical site infection (SSI) [1,2,3,4,5,6]
Design A pilot, randomised controlled, parallel, singleblinded, single-centre, phase II/III trial was conducted in which patients were allocated in a 1:1 ratio to receive either cefuroxime bolus-infusion or standard bolus-dose antibiotic prophylaxis before colorectal surgery
Ethical approval was obtained from the Health Research Authority (Reference 15/YH/0260), the protocol was reviewed by the Medical Health Research Authority (MHRA), and the study was conducted according to Good Clinical Practice standards with all patients providing informed consent
Summary
Colorectal surgery is a common procedure, with approximately 100,000 operations annually within England, with 18–27% developing a surgical site infection (SSI) [1,2,3,4,5,6]. SSIs are a major healthcare concern as they are associated with increased morbidity, mortality, and cost [7]. In an attempt to prevent superficial and deep SSIs, antibiotic prophylaxis is given peri-operatively, normally as a bolus dose within the hour before surgery. Antibiotic prophylaxis is effective; when initially introduced for colorectal surgery, it reduced superficial and deep SSIs rates from 40 to 10% [8]. A potential reason for increased SSI rates may be suboptimal dosing of standard
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callMore From: European Journal of Clinical Microbiology & Infectious Diseases
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
