Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting

Phase 3

Completed

• Conditions: Surgical Site Infections
• Interventions: Drug: Mupirocin

• Registration Number: NCT01949935
• Lead Sponsor: Horizon Health Network

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2012-12-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-20
• Last Update Submitted: 2013-09-20
• Study First Posted: 2013-09-25
• Last Update Posted: 2013-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 974

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Mupirocin	Placebo made from Glaxal base Applied once 1 day preoperatively and bid for 3 days postoperatively.
Mupirocin	Mupirocin	Mupirocin ointment applied to nares once 1 day preoperatively and bid for 3 days postoperatively.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New Brunswick Heart Centre, Saint John Regional Hospital; 🇨🇦 Saint John, New Brunswick, Canada