Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

974 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-05-31

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.

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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.

Conditions

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Surgical Site Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Mupirocin

Intervention Type DRUG

Mupirocin

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

Group Type EXPERIMENTAL

Mupirocin

Intervention Type DRUG

Interventions

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Mupirocin

Intervention Type DRUG

Other Intervention Names

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Bactroban

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