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Completed

NCT Number: NCT02089568

Prophylaxis Of Wound Infections- Antibiotics in Renal Donation

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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Key information

Conditions

Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Co-amoxiclav

Drug

Will receive 1.2g co-amoxiclav at induction

Other names: Augmentin

normal saline

Drug

Placebo - 0.9% saline

Primary outcomes

  1. Rate of infection after surgery

    Time frame: 24 months

Secondary outcomes

  1. Ultrasonic evidence of wound healing

    Time frame: 24 months

    Wounds will be assessed using high resolution ultrasound to assess dermal and epidermal healing.

  2. Length of hospital stay

    Time frame: 24 months

  3. Readmission rates

    Time frame: 24 months

  4. Antibiotic associated side effects

    Time frame: 24 months

    Including diarrhoea and allergic reactions

  5. Return to work and normal activities

    Time frame: 24 months

  6. Quality of life

    Time frame: 24 months

  7. Relative costs

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: POWAR

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2014
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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