Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting (MIR-CABG)

September 20, 2013 updated by: Dr Craig Brown, Horizon Health Network

MIR-CABG: A Randomized, Double-blind, Placebo-controlled, Single-Center Study to Evaluate the Impact of Mupirocin on Infection Rate Post Coronary Artery Bypass Grafting

The hypothesis is that application of Mupirocin to the nose before and after coronary artery bypass grafting surgery will reduce the incidence of surgical site infections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mupirocin applied to the nares is effective in eradicating nasal carriage of Staphylococcus species. Abundant evidence has documented that a majority of gram positive surgical site infections share bacterial phenotypes identical with nasal phage types. Conflicting literature exists regarding the efficacy of mupirocin in reducing the incidence of surgical site infections. A randomized prospective double-blind placebo-controlled trial is needed to help settle this question in the setting of coronary artery bypass grafting surgery where surgical site infections carry significant morbidity, cost, and mortality.

Study Type

Interventional

Enrollment (Actual)

974

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • New Brunswick Heart Centre, Saint John Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults >18 years old undergoing Coronary Artery Bypass Grafting Surgery (CABG) with or without concomitant cardiac valve surgery or other cardiac surgery,
  • Median sternotomy wound
  • Capable of informed consent

Exclusion Criteria:

  • Allergy to mupirocin or components
  • Pregnant or lactating females
  • Emergency surgery
  • Pre-existing ongoing infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Placebo made from Glaxal base Applied once 1 day preoperatively and bid for 3 days postoperatively.
Drug: Mupirocin
Other Names:
  • Bactroban
Experimental: Mupirocin
Mupirocin ointment applied to nares once 1 day preoperatively and bid for 3 days postoperatively.
Drug: Mupirocin
Other Names:
  • Bactroban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection
Time Frame: <30 days post operation
Surgical site infections (SSI) are classified as superficial, deep, or organ surgical site infections based on CDC definition.
<30 days post operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: < or = 30 days post operation
< or = 30 days post operation
Serious adverse durg effects
Time Frame: < or = 30 day post operation
Rashes, rhinorrhea, pruritis, bleeding from nares
< or = 30 day post operation
S. aureus carrier status
Time Frame: < or = 30 day post operation
Nasal carriage of Staphylococcus aureus assess pre-intervention and post-intervention.
< or = 30 day post operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of subtypes of surgical site infections.
Time Frame: < or = 30 days post operation.
Subtypes include deep sternal wound, mediastinitis, leg saphenous vein harvest site infections.
< or = 30 days post operation.
Incidence of pneumonia
Time Frame: < or = 30 days post operation.
As diagnosed by sputum, radiographic, and clinical means.
< or = 30 days post operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Horizon Health Network

Investigators

  • Principal Investigator: Craig D Brown, BSc (Med), MD, FRCSC, FACS, New Brunswick Heart Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

September 20, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Estimate)

September 25, 2013

Last Update Submitted That Met QC Criteria

September 20, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBHC-MIR004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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