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Completed

NCT Number: NCT01949935

Efficacy Study of Mupirocin on Infection After 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.

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Key information

Conditions

Surgical Site Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

New Brunswick Heart Centre, Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Mupirocin

Drug

Other names: Bactroban

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mortality

    Time frame: < or = 30 days post operation

  2. Serious adverse durg effects

    Time frame: < or = 30 day post operation

    Rashes, rhinorrhea, pruritis, bleeding from nares

  3. S. aureus carrier status

    Time frame: < or = 30 day post operation

    Nasal carriage of Staphylococcus aureus assess pre-intervention and post-intervention.

Other outcomes

  1. 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.

  2. Incidence of pneumonia

    Time frame: < or = 30 days post operation.

    As diagnosed by sputum, radiographic, and clinical means.

Sponsors and collaborators

Lead sponsor

Horizon Health Network

Other

Registry information

Official study title

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

Acronym: MIR-CABG

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 25, 2013
Registry last updated
Sep 25, 2013

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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