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

H

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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