Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting

Surgical Site Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949935
• Other study ID #: NBHC-MIR004
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2012
• Last updated: September 20, 2013
• Start date: March 2009
• Est. completion date: May 2013

Study information

• Verified date: September 2013
• Source: Horizon Health Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Horizon Health Network Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 974
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infections
• Surgical Wound Infection

Intervention

Drug:
• Mupirocin

Locations

Country	Name	City	State
Canada	New Brunswick Heart Centre, Saint John Regional Hospital	Saint John	New Brunswick

Sponsors (1)

Lead Sponsor	Collaborator
Horizon Health Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of subtypes of surgical site infections.	Subtypes include deep sternal wound, mediastinitis, leg saphenous vein harvest site infections.	< or = 30 days post operation.	No
Other	Incidence of pneumonia	As diagnosed by sputum, radiographic, and clinical means.	< or = 30 days post operation.	No
Primary	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	No
Secondary	Mortality		< or = 30 days post operation	No
Secondary	Serious adverse durg effects	Rashes, rhinorrhea, pruritis, bleeding from nares	< or = 30 day post operation	Yes
Secondary	S. aureus carrier status	Nasal carriage of Staphylococcus aureus assess pre-intervention and post-intervention.	< or = 30 day post operation	No