Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Surgical Site Infections

Intervention / Treatment
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* Drug: Mupirocin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Placebo made from Glaxal base Applied once 1 day preoperatively and bid for 3 days postoperatively. | Drug: Mupirocin<br> <br> * Other names: Bactroban;|
| Experimental: Mupirocin<br>Mupirocin ointment applied to nares once 1 day preoperatively and bid for 3 days postoperatively. | Drug: Mupirocin<br> <br> * Other names: Bactroban;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mupirocin, Surgical Site Infections, Coronary Artery Bypass Grafting