Prophylaxis Of Wound Infections- Antibiotics in Renal Donation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-08-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Drug: co-amoxiclav

experimental

Group Type EXPERIMENTAL

Co-Amoxiclav

Intervention Type DRUG

Will receive 1.2g co-amoxiclav at induction

Control

comparator

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Placebo - 0.9% saline

Interventions

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Co-Amoxiclav

Will receive 1.2g co-amoxiclav at induction

Intervention Type DRUG

Normal Saline

Placebo - 0.9% saline

Intervention Type DRUG

Other Intervention Names

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Augmentin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No