Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting (MIR-CABG)

Horizon Health Network

Status and phase: Completed; Phase 3

Conditions: Surgical Site Infections

Treatments: Drug: Mupirocin

Study type: Interventional

Funder types: Other

Identifiers

NCT01949935

NBHC-MIR004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 974 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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974 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Placebo made from Glaxal base Applied once 1 day preoperatively and bid for 3 days postoperatively.

Treatment:

Drug: Mupirocin

Mupirocin

Experimental group

Description:

Mupirocin ointment applied to nares once 1 day preoperatively and bid for 3 days postoperatively.

Treatment:

Drug: Mupirocin