MedDataX Logo

Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting

NCT ID: NCT01949935

Last Updated: 2013-09-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Site Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Mupirocin Surgical Site Infections Coronary Artery Bypass Grafting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mupirocin

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bactroban

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Horizon Health Network

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Craig Brown

Director of Clinical Trials, New Brunswick Heart Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Craig D Brown, BSc (Med), MD, FRCSC, FACS

Role: PRINCIPAL_INVESTIGATOR

New Brunswick Heart Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

New Brunswick Heart Centre, Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NBHC-MIR004

Identifier Type: -

Identifier Source: org_study_id