Are phrophylactic antibiotics necessary before laparoscopic living kidney donation? A double blind, randomised, controlled trial. - POWAR study (Prophylaxis of wound infections - Antibiotics in Renal donation)

Guys and St Thomas NHS Foundation Trust0 个研究点目标入组 295 人开始时间: 2012年10月25日最近更新: 2019年6月30日

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•All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included.
•Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice.
•Women of child-bearing age taking adequate contraception (oral contraceptive pill or depot injections) will be included.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 400

•Patients with a known allergy to penicillin or other antibiotics.
•Patients with MRSA colonisation.
•Participation in another investigational study within the previous 90 days.
•Pregnant or breast-feeding women.
•Patients who have insufficient understanding of the trial.
•Patients who have Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients.
•Patients who have a History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another ß-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).
•Patients who have a History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.

发起方

Guys and St Thomas NHS Foundation Trust