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

Primary Purpose

Infection

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Co-Amoxiclav
Normal Saline
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection focused on measuring Living donation, Antibiotics, Laparoscopic surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guy's and St Thomas' NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug: co-amoxiclav

Control

Arm Description

experimental

comparator

Outcomes

Primary Outcome Measures

Rate of infection after surgery

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2014
Last Updated
August 18, 2016
Sponsor
Guy's and St Thomas' NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02089568
Brief Title
Prophylaxis Of Wound Infections- Antibiotics in Renal Donation
Acronym
POWAR
Official Title
Are Prophylactic Antibiotics Necessary Before Laparoscopic Living Kidney Donation? A Double Blind, Randomised, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Living donation, Antibiotics, Laparoscopic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug: co-amoxiclav
Arm Type
Experimental
Arm Description
experimental
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
comparator
Intervention Type
Drug
Intervention Name(s)
Co-Amoxiclav
Other Intervention Name(s)
Augmentin
Intervention Description
Will receive 1.2g co-amoxiclav at induction
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Placebo - 0.9% saline
Primary Outcome Measure Information:
Title
Rate of infection after surgery
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Ultrasonic evidence of wound healing
Description
Wounds will be assessed using high resolution ultrasound to assess dermal and epidermal healing.
Time Frame
24 months
Title
Length of hospital stay
Time Frame
24 months
Title
Readmission rates
Time Frame
24 months
Title
Antibiotic associated side effects
Description
Including diarrhoea and allergic reactions
Time Frame
24 months
Title
Return to work and normal activities
Time Frame
24 months
Title
Quality of life
Time Frame
24 months
Title
Relative costs
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nizam Mamode
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Prophylaxis Of Wound Infections- Antibiotics in Renal Donation

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