Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting (MIR-CABG)
Primary Purpose
Surgical Site Infections
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Mupirocin
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infections focused on measuring Mupirocin, Surgical Site Infections, Coronary Artery Bypass Grafting
Eligibility Criteria
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
Sites / Locations
- New Brunswick Heart Centre, Saint John Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Mupirocin
Arm Description
Placebo made from Glaxal base Applied once 1 day preoperatively and bid for 3 days postoperatively.
Mupirocin ointment applied to nares once 1 day preoperatively and bid for 3 days postoperatively.
Outcomes
Primary Outcome Measures
Surgical Site Infection
Surgical site infections (SSI) are classified as superficial, deep, or organ surgical site infections based on CDC definition.
Secondary Outcome Measures
Mortality
Serious adverse durg effects
Rashes, rhinorrhea, pruritis, bleeding from nares
S. aureus carrier status
Nasal carriage of Staphylococcus aureus assess pre-intervention and post-intervention.
Full Information
NCT ID
NCT01949935
First Posted
December 5, 2012
Last Updated
September 20, 2013
Sponsor
Horizon Health Network
1. Study Identification
Unique Protocol Identification Number
NCT01949935
Brief Title
Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting
Acronym
MIR-CABG
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Horizon Health Network
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infections
Keywords
Mupirocin, Surgical Site Infections, Coronary Artery Bypass Grafting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
974 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo made from Glaxal base Applied once 1 day preoperatively and bid for 3 days postoperatively.
Arm Title
Mupirocin
Arm Type
Experimental
Arm Description
Mupirocin ointment applied to nares once 1 day preoperatively and bid for 3 days postoperatively.
Intervention Type
Drug
Intervention Name(s)
Mupirocin
Other Intervention Name(s)
Bactroban
Primary Outcome Measure Information:
Title
Surgical Site Infection
Description
Surgical site infections (SSI) are classified as superficial, deep, or organ surgical site infections based on CDC definition.
Time Frame
<30 days post operation
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
< or = 30 days post operation
Title
Serious adverse durg effects
Description
Rashes, rhinorrhea, pruritis, bleeding from nares
Time Frame
< or = 30 day post operation
Title
S. aureus carrier status
Description
Nasal carriage of Staphylococcus aureus assess pre-intervention and post-intervention.
Time Frame
< or = 30 day post operation
Other Pre-specified Outcome Measures:
Title
Incidence of subtypes of surgical site infections.
Description
Subtypes include deep sternal wound, mediastinitis, leg saphenous vein harvest site infections.
Time Frame
< or = 30 days post operation.
Title
Incidence of pneumonia
Description
As diagnosed by sputum, radiographic, and clinical means.
Time Frame
< or = 30 days post operation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig D Brown, BSc (Med), MD, FRCSC, FACS
Organizational Affiliation
New Brunswick Heart Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Brunswick Heart Centre, Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting
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