Ignite Creation Date:
2025-12-17 @ 2:48 PM
Ignite Modification Date:
2025-12-23 @ 1:43 PM
Study NCT ID:
NCT05439395
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2022-06-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of a composite endpoint consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection', 'timeFrame': 'up to 6 months after surgery', 'description': 'Combination of:\n\n* Incidence of sternum instability\n* Incidence of sternum dehiscence\n* Incidence of superficial and deep sternal wound infection according to classification of Centers for Disease Control and Prevention (CDC)'}], 'secondaryOutcomes': [{'measure': 'Incidence of sternum instability', 'timeFrame': 'up to 6 months after surgery', 'description': 'Number of patients presenting with instability of the sternum after sternal closure with Steelex® Sternum Set'}, {'measure': 'Incidence of sternum dehiscence', 'timeFrame': 'up to 6 months after surgery', 'description': 'Number of patients presenting with dehiscence of the sternum after sternal closure with Steelex® Sternum Set'}, {'measure': 'Incidence of superficial and deep sternal wound infection', 'timeFrame': 'up to 6 months after surgery', 'description': 'Number of patients presenting with superficial and deep sternal wound infection according to CDC classification after sternal closure with Steelex® Sternum Set'}, {'measure': 'Incidence of other cardiac and cerebral complications', 'timeFrame': 'up to 6 months after surgery', 'description': 'Number of patients presenting with other cardiac and cerebral complications such as stroke, myocardial infarction, death, as well as mediastinitis after sternal closure with Steelex® Sternum Set'}, {'measure': 'Incidence of suture related complications', 'timeFrame': 'up to 6 months after surgery', 'description': 'Number of patients presenting with suture related complications (e.g. wire breakage) after sternal closure with Steelex® Sternum Set'}, {'measure': 'Length of hospital stay', 'timeFrame': 'until discharge (approximately 10 days postoperative)', 'description': 'Number of days the patient has to stay in hospital'}, {'measure': 'Length of intensive care unit stay', 'timeFrame': 'until discharge (approximately 10 days postoperative)', 'description': 'Number of days the patient has to stay in intensive care unit after intervention'}, {'measure': 'Health Status measured with EQ-5D-5L Score', 'timeFrame': 'up to 6 months after surgery', 'description': "EQ-5D-5L is a Quality of Life Score introduced by the EuroQol Group. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).\n\nDescriptive system comprises five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels (5L): no problems, slight problems, moderate problems, severe problems, extreme problems. Each answer results in a 1-digit number. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.\n\nThe EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'."}, {'measure': 'Intraoperative handling of the Steelex® Sternum Set', 'timeFrame': 'at time of surgery', 'description': 'the handling is examined using a survey, which will be answered and filled out prospectively and anonymously once by all involved cardiac surgeons'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Median Sternotomy', 'Partial Sternotomy', 'Coronary Artery Bypass Grafting (CABG)', 'Cardiac Valve Replacement', 'Cardiac Valve Reconstruction'], 'conditions': ['Coronary Artery Disease', 'Cardiac Valve Insufficiency', 'Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure. The data from 2 clinics located in Germany and Spain participating in the "OPTICABG" as well as in the "PREMIVALVE" study will be used for assessment. Only patients receiving a complete or a partial sternotomy closed with Steelex® Sternum Set will be included in the analysis. "OPTICABG" patients were followed up 3 months after surgery and "PREMIVALVE" patients until 6 months after surgery. Adverse Events (AE) / Serious Adverse Events (SAE)(e.g. surgical site infection, sternum stability, stroke, myocardial infraction, death etc.) reported in both studies will be used for the STERCCAS analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving a partial or a complete sternotomy closed with Steelex Sternum Set participating either in the OPTICABG or PREMIVALVE study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OPTICABG study patients undergoing an elective, primary coronary artery bypass graft surgery (CABG) receiving a sternotomy, by whom the sternum was closed using Steelex® Sternum Set.\n* PREMIVALVE study patients undergoing a cardiac valve replacement or reconstruction receiving a complete or partial sternotomy, by whom the sternum was closed using Steelex® Sternum Set.\n* Eligible patients from the OPTICABG study and PREMIVALVE study who have provided their written informed consent\n* Age ≥18 years\n\nExclusion Criteria:\n\n* OPTICABG and PREMIVALVE patients receiving a sternotomy or partial sternotomy which was not closed with Steelex® Sternum Set.'}, 'identificationModule': {'nctId': 'NCT05439395', 'acronym': 'STERCCAS', 'briefTitle': 'Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Multi Center, International, Single-arm, Retrospective, Observational Post Market Clinical Follow-Up (PMCF) Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure in Patients Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'AAG-O-H-2028'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'STEELEX', 'description': 'Steelex® Sternum Set for sternal closure', 'interventionNames': ['Device: Sternum Closure after Cardiac Surgery']}], 'interventions': [{'name': 'Sternum Closure after Cardiac Surgery', 'type': 'DEVICE', 'description': 'Sternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction.', 'armGroupLabels': ['STEELEX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70376', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert Bosch KH Stuttgart', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '08026', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu I Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'B.Braun Surgical SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}