Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 11:36 PM
Study NCT ID:
NCT01949935
Status:
COMPLETED
Last Update Posted:
2013-09-25
First Post:
2012-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016712', 'term': 'Mupirocin'}], 'ancestors': [{'id': 'D004852', 'term': 'Epoxy Compounds'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 974}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-20', 'studyFirstSubmitDate': '2012-12-05', 'studyFirstSubmitQcDate': '2013-09-20', 'lastUpdatePostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of subtypes of surgical site infections.', 'timeFrame': '< or = 30 days post operation.', 'description': 'Subtypes include deep sternal wound, mediastinitis, leg saphenous vein harvest site infections.'}, {'measure': 'Incidence of pneumonia', 'timeFrame': '< or = 30 days post operation.', 'description': 'As diagnosed by sputum, radiographic, and clinical means.'}], 'primaryOutcomes': [{'measure': 'Surgical Site Infection', 'timeFrame': '<30 days post operation', 'description': 'Surgical site infections (SSI) are classified as superficial, deep, or organ surgical site infections based on CDC definition.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '< or = 30 days post operation'}, {'measure': 'Serious adverse durg effects', 'timeFrame': '< or = 30 day post operation', 'description': 'Rashes, rhinorrhea, pruritis, bleeding from nares'}, {'measure': 'S. aureus carrier status', 'timeFrame': '< or = 30 day post operation', 'description': 'Nasal carriage of Staphylococcus aureus assess pre-intervention and post-intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mupirocin', 'Surgical Site Infections', 'Coronary Artery Bypass Grafting'], 'conditions': ['Surgical Site Infections']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\>18 years old undergoing Coronary Artery Bypass Grafting Surgery (CABG) with or without concomitant cardiac valve surgery or other cardiac surgery,\n* Median sternotomy wound\n* Capable of informed consent\n\nExclusion Criteria:\n\n* Allergy to mupirocin or components\n* Pregnant or lactating females\n* Emergency surgery\n* Pre-existing ongoing infection'}, 'identificationModule': {'nctId': 'NCT01949935', 'acronym': 'MIR-CABG', 'briefTitle': 'Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting', 'organization': {'class': 'OTHER', 'fullName': 'Horizon Health Network'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NBHC-MIR004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Placebo made from Glaxal base Applied once 1 day preoperatively and bid for 3 days postoperatively.', 'interventionNames': ['Drug: Mupirocin']}, {'type': 'EXPERIMENTAL', 'label': 'Mupirocin', 'description': 'Mupirocin ointment applied to nares once 1 day preoperatively and bid for 3 days postoperatively.', 'interventionNames': ['Drug: Mupirocin']}], 'interventions': [{'name': 'Mupirocin', 'type': 'DRUG', 'otherNames': ['Bactroban'], 'armGroupLabels': ['Control', 'Mupirocin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'New Brunswick Heart Centre, Saint John Regional Hospital', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}], 'overallOfficials': [{'name': 'Craig D Brown, BSc (Med), MD, FRCSC, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Brunswick Heart Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Horizon Health Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Trials, New Brunswick Heart Centre', 'investigatorFullName': 'Dr Craig Brown', 'investigatorAffiliation': 'Horizon Health Network'}}}}