Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-02-24 @ 6:21 AM
Study NCT ID:
NCT01457859
Status:
UNKNOWN
Last Update Posted:
2011-10-24
First Post:
2011-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery
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': 'D014260', 'term': 'Triclosan'}], 'ancestors': [{'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 410}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-10-21', 'studyFirstSubmitDate': '2011-10-16', 'studyFirstSubmitQcDate': '2011-10-21', 'lastUpdatePostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'leg wound infection', 'timeFrame': 'Up to 45 days postsurgery', 'description': 'Proportion of subjects with leg wound infection in research versus control group within 45 days of surgery according to CDC SSI criteria'}], 'secondaryOutcomes': [{'measure': 'Antibiotics administration', 'timeFrame': 'Up to 45 days postsurgery', 'description': 'Amount of administered antibiotic for leg wound infection after surgery'}, {'measure': 'Hospital Length of stay', 'timeFrame': 'Average of 7 days postsurgery'}, {'measure': 'Incidence of hospital re-admission due to leg wound infection', 'timeFrame': 'Within 45 days postsurgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Complication of Coronary Artery Bypass Graft', 'Surgical Wound Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether triclosan-coated sutures reduces wound infections compared to regular non-coated sutures, after saphenous vein harvesting in CABG patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older with written informed consent\n* Male and female subjects\n* Subjects scheduled for an elective and urgent CABG surgery that includes saphenous vein harvesting.\n\nExclusion Criteria:\n\n* Known allergy or intolerance to triclosan\n* Different surgical prophylactic antibiotic regimen than common in the department.\n* Continuous preoperative and predicted postoperative antibiotic treatment.'}, 'identificationModule': {'nctId': 'NCT01457859', 'briefTitle': 'Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Effectiveness of Triclosan Coated VICRYL\\MONOCRYL Sutures in Preventing Leg Wound Infection Compared to POLYSORB\\ BIOSYN Sutures in Patients After Coronary Bypass Surgery- a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RMB-0228.CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional sutures', 'interventionNames': ['Other: Conventional non-coated surgical sutures']}, {'type': 'EXPERIMENTAL', 'label': 'Antiseptic sutures', 'interventionNames': ['Drug: Triclosan']}], 'interventions': [{'name': 'Triclosan', 'type': 'DRUG', 'description': 'Triclosan coated surgical sewing threads (VICRYL+ and MONOCRYL+) applied for leg wound closure after CABG', 'armGroupLabels': ['Antiseptic sutures']}, {'name': 'Conventional non-coated surgical sutures', 'type': 'OTHER', 'description': 'Conventional non-coated surgical sewing threads (POLYSORB and BIOSYN) will be applied after CABG for leg wound closure', 'armGroupLabels': ['Conventional sutures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'contacts': [{'name': 'Liran Shani, MD', 'role': 'CONTACT', 'email': 'l_shani@rambam.health.gov.il'}, {'name': 'Liran Shani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rambam Health Care Campus, Depatment of cardiac surgery', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Liran Shani, MD', 'role': 'CONTACT', 'email': 'l_shani@rambam.health.gov.il'}], 'overallOfficials': [{'name': 'Liran Shani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiac surgery resident', 'investigatorFullName': 'Dr. Shani Liran', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}