Prophylaxis Of Wound Infections- Antibiotics in Renal Donation

Infection Clinical Trial

— POWAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089568
• Other study ID #: POWAR
• Secondary ID: 2012-000942-36
• Status: Completed
• Phase: Phase 4
• First received: March 14, 2014
• Last updated: August 18, 2016
• Start date: July 2012
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection

Intervention

Drug:
• Co-Amoxiclav
Will receive 1.2g co-amoxiclav at induction
• Normal Saline
Placebo - 0.9% saline

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (1)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of infection after surgery		24 months	No
Secondary	Ultrasonic evidence of wound healing	Wounds will be assessed using high resolution ultrasound to assess dermal and epidermal healing.	24 months	No
Secondary	Length of hospital stay		24 months	No
Secondary	Readmission rates		24 months	No
Secondary	Antibiotic associated side effects	Including diarrhoea and allergic reactions	24 months	No
Secondary	Return to work and normal activities		24 months	No
Secondary	Quality of life		24 months	No
Secondary	Relative costs		24 months	No