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Prophylaxis Of Wound Infections- Antibiotics in Renal Donation

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02089568
Acronym
POWAR
Enrollment
284
Registered
2014-03-18
Start date
2012-07-31
Completion date
2016-08-31
Last updated
2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

Living donation, Antibiotics, Laparoscopic surgery

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

Interventions

Will receive 1.2g co-amoxiclav at induction

DRUGNormal Saline

Placebo - 0.9% saline

Sponsors

Guy's and St Thomas' NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Rate of infection after surgery24 months

Secondary

MeasureTime frameDescription
Length of hospital stay24 months
Readmission rates24 months
Antibiotic associated side effects24 monthsIncluding diarrhoea and allergic reactions
Ultrasonic evidence of wound healing24 monthsWounds will be assessed using high resolution ultrasound to assess dermal and epidermal healing.
Quality of life24 months
Relative costs24 months
Return to work and normal activities24 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026