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Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting

Information source: Horizon Health Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Surgical Site Infections

Intervention: Mupirocin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Horizon Health Network

Official(s) and/or principal investigator(s):
Craig D Brown, BSc (Med), MD, FRCSC, FACS, Principal Investigator, Affiliation: New Brunswick Heart Centre

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.

Clinical Details

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

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

Primary outcome: Surgical Site Infection

Secondary outcome:

Mortality

Serious adverse durg effects

S. aureus carrier status

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.

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

New Brunswick Heart Centre, Saint John Regional Hospital, Saint John, New Brunswick E2L 4L2, Canada
Additional Information

Starting date: March 2009
Last updated: September 20, 2013

Page last updated: August 23, 2015

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