Prophylaxis Of Wound Infections- Antibiotics in Renal Donation (POWAR)

Guy's and St Thomas' NHS Foundation Trust

Status and phase: Completed; Phase 4

Conditions: Infection

Treatments: Drug: Co-Amoxiclav; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02089568

2012-000942-36 (EudraCT Number)

POWAR

Details and patient eligibility

About

The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney donation surgery prevent infection.

Full description

Subjects undergoing laparoscopic donor nephrectomy will be randomised to either a single dose of intravenous co-amoxiclav or placebo prior to surgery. Outcome measures include any infections, length of stay and costs

Enrollment: 284 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 will be included.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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284 participants in 2 patient groups, including a placebo group

Drug: co-amoxiclav

Experimental group

Description:

experimental

Treatment:

Drug: Co-Amoxiclav

Control

Placebo Comparator group

Description:

comparator

Treatment:

Drug: Normal Saline