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Prophylaxis Of Wound Infections- Antibiotics in Renal Donation (POWAR)

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ClinicalTrials.gov Identifier: NCT02089568
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Nizam Mamode, Guy's and St Thomas' NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Infection Drug: Co-Amoxiclav Drug: Normal Saline Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Are Prophylactic Antibiotics Necessary Before Laparoscopic Living Kidney Donation? A Double Blind, Randomised, Controlled Trial.
Study Start Date : July 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Experimental: Drug: co-amoxiclav
experimental
 Drug: Co-Amoxiclav
Will receive 1.2g co-amoxiclav at induction
Other Name: Augmentin
Placebo Comparator: Control
comparator
 Drug: Normal Saline
Placebo - 0.9% saline


Outcome Measures
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Primary Outcome Measures :
  1. Rate of infection after surgery [ Time Frame: 24 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089568


Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Nizam Mamode Guy's and St Thomas' NHS Foundation Trust
More Information
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Responsible Party: Nizam Mamode, Consultant Transplant Surgeon, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02089568    
Other Study ID Numbers: POWAR
2012-000942-36 ( EudraCT Number )
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Keywords provided by Nizam Mamode, Guy's and St Thomas' NHS Foundation Trust:
Living donation
Antibiotics
Laparoscopic surgery
Additional relevant MeSH terms:
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Infection
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
 beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action