Topic: Renal disorders
Conditions
Interventions
A single intravenous dose (1.2g) of the IMP (or placebo) will be given at induction of anaesthesia.
Sponsors
Guy's and St. Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included 2. 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 3. Women of child-bearing age taking adequate contraception will be included
Exclusion criteria
Exclusion criteria: 1. Patients with a known allergy to penicillin or other antibiotics 2. Patients with MRSA colonisation 3. Participation in another investigational study within the previous 90 days 4. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be a composite endpoint of any infection; this will include surgical site infections as well as urinary tract, respiratory and any other infections, within 30 days of surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ultrasonic evidence of wound healing 2. Length of hospital stay 3. Readmission rates 4. Antibiotic associated side effects (including diarrhoea and allergic reactions), return to work and normal activities 5. Quality of life and relative costs | — |
Countries
United Kingdom
Outcome results
None listed