Phase 2
N=90
Continuous Antibiotic Prophylaxis in Colorectal Surgery
Surgical Site Infection
Bottom Line
View on ClinicalTrials.gov: NCT02445859 ↗Enrolled (actual)
90
Serious AEs
9.4%
Results posted
Sep 2019
Primary outcome: Primary: Number of Patients With a Surgical Site Infection — 10; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cefuroxime 4 hourly bolus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Leeds
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With a Surgical Site Infection |
10; 13 | — |
Summary
We propose to randomise patients due to undergo colorectal surgery to standard antibiotic prophylaxis or an interventional antibiotic prophylaxis regimen and assess surgical wound infection rates. Standard antibiotic prophylaxis is a pre-operative injection of cefuroxime, repeated every 4 hours. The intervention regimen is a loading dose of cefuroxime followed by a continuous infusion of cefuroxime until the end of surgery. The intervention regimen dosing will be calculated using a patient's renal function and body weight. The intervention regimen will target a free serum drug concentration of 64mg/L. This serum level is 4x the MIC90 for colonising Enterobacteriaceae. The rational for this dosing regimen is summarised below. The primary objective of the study is to reduce by 50% the rate of surgical wound infections after colorectal surgery.
Eligibility Criteria
Inclusion criteria
- Undergoing colorectal surgery (incision, excision or anastomosis of the large bowel, including anastomosis of small to large bowel)
- Age >18.
- Expected duration of surgery > 2hours
- Creatinine clearance > 40 ml/min
- Cefuroxime/metronidazole are appropriate antibiotic prophylaxis regimens.
- Patient capable of giving informed consent
- Patients undergoing colorectal surgery plus additional surgery e.g. plastic surgery, urological surgery, gynaecological surgery.
- If it is not possible to obtain intra-operative blood samples e.g. difficult vascular access, or pre-operative swabs e.g. anatomy makes it difficult to obtain, patients will be included and this information treated as missing data. Patients on antibiotic treatment for an existing infection (except SSIs) can be included in the study
Exclusion Criteria
- Unable to consent
- Pregnancy
- Expected duration of surgery <2hours
- Creatinine clearance <40ml/min
- Individual level microbiological advice for non cefuroxime based prophylaxis
- Cephalosporin allergy
- Penicillin allergy (hypersensitivity reaction only)
- Coumarin (warfarin and acenocoumarol) treatment
- Active blood borne virus infection e.g. HIV, hepatitis.
- Seizure history
- Concurrent use of probenecid
- Current participation in a research project aimed at reducing SSIs
- Antibiotics for treatment of a systemic Gram negative infection within 2 hours of initiation of surgery (Vancomycin, Teicoplanin, Daptomycin, Linezolid, Flucloxacillin. Nitrofurantoin and Clarithromycin would be permissible antibiotics without systemic Gram negative antibiotics).
- A current diagnosis of a SSI at the time of study entry.
Data sourced from ClinicalTrials.gov (NCT02445859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.