Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-24 @ 2:40 PM
NCT ID:
NCT02445859
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02445859
Study Brief:
Protocol Section:
NCT02445859