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Infection | Prophylaxis Of Wound Infections- Antibiotics in Renal Donation

Infection research study

What is the primary objective of this study?

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

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Infection

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Co-AmoxiclavWill receive 1.2g co-amoxiclav at induction

Drug:Normal SalinePlacebo - 0.9% saline

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Drug: co-amoxiclavexperimental

Controlcomparator

Study Status

Completed

Start Date: July 2012

Completed Date: August 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Rate of infection after surgery

Secondary Outcome: Ultrasonic evidence of wound healing

Study sponsors, principal investigator, and references

Principal Investigator: Nizam Mamode

Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02089568

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