University of Hertfordshire

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Description

POWAR Clinical Trial:
This is a study designed to investigate whether prophylactic antibiotics are necessary before laparoscopic living kidney donation? A double blind, randomised, controlled trial that has already started at Guy’s Hospital. Our role will be to undertake the interim analysis, and if the trial continues to undertake the further formal end of trial data analysis. The trial is ongoing until August 2016.
The trial is designed as a double-blind, randomised, controlled trial of patients undergoing hand-assisted laparoscopic kidney donation. The patients will be randomised to either: 1) A single dose of 1.2g co-amoxiclav intravenously at induction of anaesthesia, or 2) A single intravenous dose of placebo (normal saline) at induction of anaesthesia. Guy’s and St Thomas’s NHS Foundation Trust have applied a superiority group sequential design, assuming an infection rate of 15% without prophylactic antibiotics, and aiming to detect a minimum clinically significant reduction to 5%. To achieve 90% power, using a binomial two sided test with 5% type I error, they require a maximum of 200 patients per arm, with an expected sample size of 142 per arm if there were no differences, and 138 under the alternative hypothesis. Trail randomisation would have been performed using a web-based computer allocation system (Sealedenvelope.com). The trial drug would have been in a numbered vial of clear fluid, so patients and clinicians will be blinded as to the allocation. Randomisation would have been stratified by centre. The primary trial outcome measure is stated as a composite endpoint of any infection; that will include surgical site infections as well as urinary tract, respiratory and any other infections, within thirty (30) days of surgery.
Short titlePOWAR
AcronymPOWAR
StatusFinished
Period1/09/1530/09/16

ID: 10148154