Surgical Site InfectionsPhase 3MIR-CABGNCT01949935
Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting
A Phase 3 study testing Mupirocin in people with Surgical Site Infections, run by Horizon Health Network at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Surgical Site Infections
- What is being tested?
- Mupirocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 974 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergy to mupirocin or components
- Pregnant or lactating females
- Emergency surgery
- Pre-existing ongoing infection
Trial locations and contacts
1 site in 1 country.
Canada1 site
New Brunswick Heart Centre, Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
About this study
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
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.
Read the 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.
- Conditions
- Surgical Site Infections
- Being tested
- Mupirocin
- Keywords
- Mupirocin, Surgical Site Infections, Coronary Artery Bypass Grafting
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MupirocinDrug
Also called Bactroban
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo made from Glaxal base Applied once 1 day preoperatively and bid for 3 days postoperatively. Receives: Drug: Mupirocin |
| Mupirocin | Experimental | Mupirocin ointment applied to nares once 1 day preoperatively and bid for 3 days postoperatively. Receives: Drug: Mupirocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
Surgical site infections (SSI) are classified as superficial, deep, or organ surgical site infections based on CDC definition.
Measured: <30 days post operation
Secondary outcomes (3)
Mortality
Measured: < or = 30 days post operation
Serious adverse durg effects
Rashes, rhinorrhea, pruritis, bleeding from nares
Measured: < or = 30 day post operation
S. aureus carrier status
Nasal carriage of Staphylococcus aureus assess pre-intervention and post-intervention.
Measured: < or = 30 day post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startMar 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 974 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Craig Brown, Horizon Health Network
- Investigators
- Craig D Brown, BSc (Med), MD, FRCSC, FACS, Principal investigator, New Brunswick Heart Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949935
- Sponsor's protocol ID
- NBHC-MIR004
- Acronym
- MIR-CABG
- Status last verified
- Sep 2013
- First submitted
- 5 Dec 2012
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01949935
- Acronym / sponsor ID
- MIR-CABG / NBHC-MIR004
- Conditions
- Surgical Site Infections
- Keywords
- Mupirocin, Surgical Site Infections, Coronary Artery Bypass Grafting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 974 participants (actual)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: MupirocinPlacebo made from Glaxal base Applied once 1 day preoperatively and bid for 3 days postoperatively. |
| Mupirocin | Experimental | Drug: MupirocinMupirocin ointment applied to nares once 1 day preoperatively and bid for 3 days postoperatively. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Allergy to mupirocin or components
- Pregnant or lactating females
- Emergency surgery
- Pre-existing ongoing infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MupirocinAlso: Bactroban | Drug | Control, Mupirocin |
Primary outcome
Surgical Site Infection
Time frame: <30 days post operation
Surgical site infections (SSI) are classified as superficial, deep, or organ surgical site infections based on CDC definition.
3 secondary outcomes
Mortality
Time frame: < or = 30 days post operation
Serious adverse durg effects
Time frame: < or = 30 day post operation
S. aureus carrier status
Time frame: < or = 30 day post operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig D Brown, BSc (Med), MD, FRCSC, FACS principal investigator
New Brunswick Heart Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mupirocin in people with Surgical Site Infections, run by Horizon Health Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: <30 days post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2013.