Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting
MIR-CABG
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
1 other identifier
interventional
974
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
September 25, 2013
CompletedSeptember 25, 2013
September 1, 2013
4.2 years
December 5, 2012
September 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical Site Infection
Surgical site infections (SSI) are classified as superficial, deep, or organ surgical site infections based on CDC definition.
<30 days post operation
Secondary Outcomes (3)
Mortality
< or = 30 days post operation
Serious adverse durg effects
< or = 30 day post operation
S. aureus carrier status
< or = 30 day post operation
Other Outcomes (2)
Incidence of subtypes of surgical site infections.
< or = 30 days post operation.
Incidence of pneumonia
< or = 30 days post operation.
Study Arms (2)
Control
PLACEBO COMPARATORPlacebo made from Glaxal base Applied once 1 day preoperatively and bid for 3 days postoperatively.
Mupirocin
EXPERIMENTALMupirocin ointment applied to nares once 1 day preoperatively and bid for 3 days postoperatively.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Allergy to mupirocin or components
- Pregnant or lactating females
- Emergency surgery
- Pre-existing ongoing infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Brunswick Heart Centre, Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Craig D Brown, BSc (Med), MD, FRCSC, FACS
New Brunswick Heart Centre
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Clinical Trials, New Brunswick Heart Centre
Study Record Dates
First Submitted
December 5, 2012
First Posted
September 25, 2013
Study Start
March 1, 2009
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
September 25, 2013
Record last verified: 2013-09