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

Are Prophylactic Antibiotics Necessary Before Laparoscopic Living Kidney Donation? A Double Blind, Randomised, Controlled Trial.

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

Study Overview

• Status: Completed
• Conditions: Infection
• Intervention / Treatment: Drug: Co-Amoxiclav; Drug: Normal Saline

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 284
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas' NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug: co-amoxiclav; experimental	Drug: Co-Amoxiclav; Will receive 1.2g co-amoxiclav at induction; Other Names: Augmentin
Placebo Comparator: Control; comparator	Drug: Normal Saline; Placebo - 0.9% saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of infection after surgery	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life		24 months
Ultrasonic evidence of wound healing	Wounds will be assessed using high resolution ultrasound to assess dermal and epidermal healing.	24 months
Length of hospital stay		24 months
Readmission rates		24 months
Antibiotic associated side effects	Including diarrhoea and allergic reactions	24 months
Return to work and normal activities		24 months
Relative costs		24 months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Nizam Mamode, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: March 14, 2014
• First Submitted That Met QC Criteria: March 14, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Antibiotics; Living donation
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: POWAR; 2012-000942-36 (EudraCT Number)