Continuous antibiotic prophylaxis in colorectal surgery.
Research type
Research Study
Full title
Colo-Pro Pilot: A pilot randomised controlled single blind trial to compare standard single dose antibiotic prophylaxis to antibiotic prophylaxis administered as a continuous infusion for the prevention of surgical wound infections in adults undergoing colorectal surgery.
IRAS ID
179100
Contact name
Andrew Kirby
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Background
After colorectal surgery patients are at high risk of suffering from an infection. To prevent post-operative infections antibiotics are given as a single dose before an operation. There is evidence that antibiotics which remain in the body at high concentrations throughout an operation (antibiotics with a long half-life) are associated with lower risks of post operative infections. Currently, these antibiotics are not used as there are increased risks of antibiotic side effects e.g. Clostridium difficile infection and the development of antibiotic resistance. Instead, antibiotics are used that remain in the body at high concentrations for only a short time (antibiotics with a short half-life). This reduces the risks of side effects, but may be less effective. One solution to this problem is to administer antibiotics with short half continuously throughout an operation. This will achieve higher concentrations during the operation, so potentially reducing the risk of a post operative infection. After the operation the drug concentration will rapidly fall and so reduce the risks of side effects from prolonged drug exposure.Importance
Approximately 12% of patients get a wound infection after colorectal surgery resulting in increased treatment (e.g. hospitalisation and antibiotics) and cost (approx. £5000 per infection).Questions answered
Standard antibiotic prophylaxis dosing is not changed based on individual patient parameters. This study will compare standard dosing to dosing based on patient weight/kidney function at a targeted blood antibiotic concentration administered as a continuous infusion during an operation. The study will therefore determine if this individualised dosing is more effective than standard dosing.Study design
This is a pilot study of a randomised controlled single blind superiority adaptive trial to compare standard single dosing of antibiotic prophylaxis vs. continuous dosing for the prevention of surgical wound infections in adults after colorectal surgery.Participant involvement
Participants will be expected to complete a day 30 questionnaire at home.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
15/YH/0260
Date of REC Opinion
7 Jul 2015
REC opinion
Further Information Favourable Opinion