Prophylaxis Of Wound Infections- Antibiotics in Renal Donation

Phase 4

Completed

• Conditions: Infection
• Interventions: Drug: Co-Amoxiclav; Drug: Normal Saline

• Registration Number: NCT02089568
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

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

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-18
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-18
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: co-amoxiclav	Co-Amoxiclav	experimental
Control	Normal Saline	comparator

Primary Outcome Measures

Name	Time	Method
Rate of infection after surgery	24 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom