Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-03 @ 4:18 AM
Study NCT ID:
NCT03346694
Status:
RECRUITING
Last Update Posted:
2022-10-26
First Post:
2017-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participant randomly assigned to either a control or one of two intervention groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 660}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2035-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of surgical site infection pertaining to each dressing studied.', 'timeFrame': 'From Post-Operative date 0 to 7th day or earlier which ever day comes first.', 'description': 'evaluate alternative dressings to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients'}], 'secondaryOutcomes': [{'measure': 'Impact of alternative dressings on rates of Sternal wound incision infection', 'timeFrame': '30 days after participant discharge.', 'description': 'Assess the impact of alternative dressing use on hospital 30-day readmission rates related to surgical site infection (SSI).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Wound of Skin']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Lwanga, S.K. & Lemeshow, S. (1991). Sample size determination in health studies: a practical manual. World Health Organization: Geneva, Switzerland.'}, {'type': 'BACKGROUND', 'citation': 'R Core Team (2016). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.'}, {'pmid': '26219113', 'type': 'RESULT', 'citation': "Barnes S. What's new in SSI prevention? AORN J. 2015 Jun;101(6):P10-2. doi: 10.1016/s0001-2092(15)00421-4. No abstract available."}, {'type': 'RESULT', 'citation': 'Ly, E. (2015). Cardiothoracic (CT) surgery data summary- all surgical site infections by quarter 2015 [PowerPoint slides]. Retrieved from personal communication.'}, {'pmid': '26244240', 'type': 'RESULT', 'citation': 'Kles CL, Murrah CP, Smith K, Baugus-Wellmeier E, Hurry T, Morris CD. Achieving and Sustaining Zero: Preventing Surgical Site Infections After Isolated Coronary Artery Bypass With Saphenous Vein Harvest Site Through Implementation of a Staff-Driven Quality Improvement Process. Dimens Crit Care Nurs. 2015 Sep-Oct;34(5):265-72. doi: 10.1097/DCC.0000000000000131.'}], 'seeAlsoLinks': [{'url': 'https://www.R-project.org/', 'label': 'A Language and environment for statistical computing'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate two alternative dressings compared to a standard Island dressing presently in use at Stanford Hospital to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients. Cardiovascular surgery patients who will have a sternotomy incision as a routine part of their surgery will be approached to voluntarily participate. Participants will be randomized to one of three dressing to determine which dressing has the lowest rate of sternal wound infection. The investigators will also assess the impact of alternative dressing use on hospital 30-day readmission rates related to SSI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who will undergo cardiac surgery via a sternotomy incision.Inclusion criteria will be patients having surgical valve, CABGs, aortic dissection, myectomy and myotomy, Cox MAZE, Myocardial bridge Un-roofing\n\nExclusion Criteria:\n\n* Patients undergoing heart transplants, Ventricular Assist Device (VAD), with postoperative courses complicated by tamponade, take-backs, and open chest incisions will also be excluded.'}, 'identificationModule': {'nctId': 'NCT03346694', 'briefTitle': 'Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing', 'orgStudyIdInfo': {'id': '41985'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dressing 1: Standard Island Dressing', 'description': 'Standard dressing that is applied on most patients with a sternotomy wound incision immediately after cardiovascular surgery before leaving the operating room. Dressing will be removed 48 hours after surgery.', 'interventionNames': ['Device: Standard Island Dressing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dressing 2: Prevena negative pressure', 'description': 'Prevena negative pressure wound suction machine dressing applied to sternotomy wound incision immediately after cardiovascular surgery. Dressing will be in use for 7 days or removed sooner if participant is discharged before end of 7 day post-operative time period.', 'interventionNames': ['Device: Prevena Negative Pressure wound dressing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dressing 3: Mepilex Border Post-Op Ag', 'description': 'Mepilex Border PostOp AG dressing impregnated with silver ions. Dressing will be in use for 7 days or removed earlier if patient is discharged before end of 7 days post0operative time period.', 'interventionNames': ['Device: Mepilex Border Post-Op Ag']}], 'interventions': [{'name': 'Standard Island Dressing', 'type': 'DEVICE', 'otherNames': ['Dressing 1'], 'description': 'participant randomized to control group before end of surgery to be applied on cardiovascular heart surgical sternal incision.', 'armGroupLabels': ['Dressing 1: Standard Island Dressing']}, {'name': 'Prevena Negative Pressure wound dressing', 'type': 'DEVICE', 'otherNames': ['Dressing 2'], 'description': 'participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision.', 'armGroupLabels': ['Dressing 2: Prevena negative pressure']}, {'name': 'Mepilex Border Post-Op Ag', 'type': 'DEVICE', 'otherNames': ['Dressing 3'], 'description': 'Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision', 'armGroupLabels': ['Dressing 3: Mepilex Border Post-Op Ag']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Stanford Healthcare', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Jack Boyd, M.D.', 'role': 'CONTACT', 'email': 'jackboyd@stanford.edu', 'phone': '650-736-2042'}, {'name': 'Clarivil Cruz Gonzales, RN', 'role': 'CONTACT', 'email': 'CCruzGonzales@stanfordhealthcare.org', 'phone': '650-542-6532'}], 'overallOfficials': [{'name': 'Jack Boyd, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Surgeon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Jack Boyd', 'investigatorAffiliation': 'Stanford University'}}}}