Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-26 @ 10:04 AM
Study NCT ID:
NCT01317095
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2011-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Hitoshi.Hirose@jefferson.edu', 'phone': '2159556925', 'title': 'Hitoshi Hirose, Professor of Surgery', 'organization': 'Thomas Jefferson University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small number of enrollment.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Wire Closure is the Intervention', 'description': 'Patients will have their sternum closed using stainless steel wires.\n\nSternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Rigid Fixation', 'description': 'Patients will have their sternum closed by rigid fixation using Starnalock plates.\n\nSternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Deep sternal infection', 'notes': 'One patient developed deep sternal infection. Patient was treated with antibiotics and muscle flap, then eventually discharged from hospital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mortality', 'notes': 'Mortality due to acute stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intubation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rigid Fixation', 'description': 'Patients will have their sternum closed by rigid fixation using Starnalock plates.'}, {'id': 'OG001', 'title': 'Wire Closure', 'description': 'Patients will have their sternum closed using stainless steel wires.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '5', 'groupId': 'OG000'}, {'value': '9', 'spread': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after surgery', 'description': 'The primary objective of this study is to determine if rigid sternal fixation can shorten the postoperative intubation time after open heart surgery compared to the wire closure', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intubation time'}, {'type': 'SECONDARY', 'title': 'Pain Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rigid Fixation', 'description': 'Patients will have their sternum closed by rigid fixation using Starnalock plates.'}, {'id': 'OG001', 'title': 'Wire Closure', 'description': 'Patients will have their sternum closed using stainless steel wires.'}], 'classes': [{'title': 'Pain score on day1', 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'Pain score on day2', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Pain score on day3', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Pain score on day4', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'Pain score on day5', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days after surgery', 'description': "One of the secondary outcomes are monitoring the patient's pain scores from postoperative day 1 till day 5.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Likert Pain Scale from 0-10 (0: no pain; 10:worst possible pain)'}, {'type': 'SECONDARY', 'title': 'Length of ICU Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rigid Fixation', 'description': 'Patients will have their sternum closed by rigid fixation using Starnalock plates.'}, {'id': 'OG001', 'title': 'Wire Closure', 'description': 'Patients will have their sternum closed using stainless steel wires.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '29', 'groupId': 'OG000'}, {'value': '55', 'spread': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'ICU stay', 'description': 'Length of postoperative intensive care unit stay.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Postoperative average intensive care unit stay (hours)'}, {'type': 'SECONDARY', 'title': 'Postop Length of Hospital Stay.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rigid Fixation', 'description': 'Patients will have their sternum closed by rigid fixation using Starnalock plates.'}, {'id': 'OG001', 'title': 'Wire Closure', 'description': 'Patients will have their sternum closed using stainless steel wires.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '4', 'groupId': 'OG000'}, {'value': '8', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Until hospital discharge', 'description': 'Postoperative length of hospital stay.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Postoperative length of hospital stay.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rigid Fixation', 'description': 'Patients will have their sternum closed by rigid fixation using Starnalock plates.\n\nSternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates.'}, {'id': 'FG001', 'title': 'Wire Closure is the Intervention', 'description': 'Patients will have their sternum closed using stainless steel wires.\n\nSternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Wire Closure is the Intervention', 'description': 'Patients will have their sternum closed using stainless steel wires.\n\nSternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates.'}, {'id': 'BG001', 'title': 'Rigid Fixation', 'description': 'Patients will have their sternum closed by rigid fixation using Starnalock plates.\n\nSternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '9', 'groupId': 'BG000'}, {'value': '65', 'spread': '8', 'groupId': 'BG001'}, {'value': '65', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-16', 'studyFirstSubmitDate': '2011-03-10', 'resultsFirstSubmitDate': '2017-10-18', 'studyFirstSubmitQcDate': '2011-03-15', 'lastUpdatePostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-16', 'studyFirstPostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation Time', 'timeFrame': '48 hours after surgery', 'description': 'The primary objective of this study is to determine if rigid sternal fixation can shorten the postoperative intubation time after open heart surgery compared to the wire closure'}], 'secondaryOutcomes': [{'measure': 'Pain Scores.', 'timeFrame': '5 days after surgery', 'description': "One of the secondary outcomes are monitoring the patient's pain scores from postoperative day 1 till day 5."}, {'measure': 'Length of ICU Stay', 'timeFrame': 'ICU stay', 'description': 'Length of postoperative intensive care unit stay.'}, {'measure': 'Postop Length of Hospital Stay.', 'timeFrame': 'Until hospital discharge', 'description': 'Postoperative length of hospital stay.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rigid fixation', 'Sternal closure', 'Open heart surgery'], 'conditions': ['Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://hospitals.jefferson.edu/departments-and-services/cardiothoracic-surgery.html', 'label': 'Division of Cardiothoracic Surgery, Thomas Jefferson University'}]}, 'descriptionModule': {'briefSummary': 'The investigators are conducting this research to compare two different methods of closure of the sternum after cardiac surgery to determine if one method is better than the other. Open heart surgery always requires a sternotomy, and at the end of surgery the sternum needs to be closed. The sternum can be closed with Stainless Steel Wires or Sternalock rigid sternal closure system with equivocal results; however, the outcomes of these two methods have never been investigated in a randomized study. Thus, the investigators are conducting this study to compare two different methods of closure if one method demonstrates any recovery benefit over the other, using randomizing the subjects 1:1 to either rigid fixation with Sternalock or stainless steel wire closure. Recover benefit will be measured by postoperative intubation time, length of intensive care unit stay, and overall postoperative length of stay', 'detailedDescription': '1. Subjects:\n\n Inclusion criteria:\n 1. scheduled (elective or urgent) coronary artery bypass graft with or without valvular surgery by our cardiothoracic surgery division.\n 2. patient age ≥18 and \\<80 .\n 3. patient undergoing elective surgery.\n 4. patient undergoing urgent surgery (defined as surgery scheduled while the patient is in the hospital and performed during the same hospital admission with stable medical condition)\n 5. patients who is willing to sign the informed consent to participate the study.\n\n Pre- operative exclusion criteria:\n 1. patient undergoing redo-sternotomy.\n 2. patient undergoing emergent surgery (defined as life-threatening or unstable condition requiring surgery on the same day of the surgical consultation.)\n 3. patients on dialysis\n 4. patients undergoing ventricular assist device insertion, transplant surgery, or aortic surgery.\n 5. patients with body mass index ≥ 40.\n 6. patients with active endocarditis.\n 7. patients with known metal allergy.\n 8. patient who refuses consent.\n 9. patient who is unable to follow the postoperative instructions.\n\n Intraoperative exclusion criteria:\n 1. osteoporosis or poor quality of sternum.\n 2. unstable sternal fracture.\n 3. sternum too thin (less than 4 mm) or too thick (greater than 14 mm) as determined by direct measurement.\n 4. bilateral mammary artery harvest (causing poor blood supply to the sternum).\n 5. patients in whom the chest needs to be left open due to medical reasons.\n2. Procedures:\n\n Preoperative testing, medical evaluation, cardiac surgery and postoperative care will all be performed per standard of care. The patients will sign a separate consent for their open heart surgery.\n\n Baseline screening: Medical history and preoperative testing are reviewed to determine if the patient is a suitable candidate of the study. If the patient meets inclusion criteria, the study will be explained and the two closure methods will be discussed; it will be explained that the method of sternal closure will be determined by randomization if they choose to participate in the study. If they still want to participate, the consent will be signed.\n\n Randomization procedure: On the day of heart surgery, subjects will be randomized 1:1 to either closure with stainless steel wires or rigid closure with Sternalock System by opening an envelope in the operating room. After randomization, if the patient meets any of the intraoperative exclusion criteria the patient will be excluded from the study.\n\n Data collection: Ventilator time, length of intensive care unit stay and length of hospital stay will be collected. Daily 6 am pain VAS (visual analog scores) scores will be collected while the patient is hospitalized. Complications such as sternal infection, sternal dehiscence, pneumonia will be monitored.\n\n Follow-up visit: At a routine postoperative follow-up visit, usually occurring at 4-8 weeks after surgery, sternal stability and pain scores will be assessed.\n3. Data analysis:\n\nPlan is 2 group comparisons using student t-tests or chi-square tests performed to identify the factors contributing to intubation time, ICU stay and hospital stay. Univariate analysis followed by multivariate analyses to identify independent risk factor will be performed by statistical package (JMP software)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. scheduled (elective or urgent) coronary artery bypass graft with or without valvular surgery by our cardiothoracic surgery division.\n2. patient age ≥18 and \\<80 .\n3. patient undergoing elective surgery.\n4. patient undergoing urgent surgery (defined as surgery scheduled while the patient is in the hospital and performed during the same hospital admission with stable medical condition)\n5. patients who is willing to sign the informed consent to participate the study.\n\nExclusion Criteria:\n\nPre- operative exclusion criteria:\n\n1. patient undergoing redo-sternotomy.\n2. patient undergoing emergent surgery (defined as life-threatening or unstable condition requiring surgery on the same day of the surgical consultation.)\n3. patients on dialysis\n4. patients undergoing ventricular assist device insertion, transplant surgery, or aortic surgery.\n5. patients with body mass index ≥ 40.\n6. patients with active endocarditis.\n7. patients with known metal allergy.\n8. patient who refuses consent.\n9. patient who is unable to follow the postoperative instructions.\n\nIntraoperative exclusion criteria:\n\n1. osteoporosis or poor quality of sternum.\n2. unstable sternal fracture.\n3. sternum too thin (less than 4 mm) or too thick (greater than 14 mm) as determined by direct measurement.\n4. bilateral mammary artery harvest (causing poor blood supply to the sternum).\n5. patients in whom the chest needs to be left open due to medical reasons.'}, 'identificationModule': {'nctId': 'NCT01317095', 'briefTitle': 'A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'A Prospective Randomized Study of Two Types of Sternal Closure After Open Heart Surgery: Rigid Sternal Fixation vs. Sternal Wire Closure', 'orgStudyIdInfo': {'id': 'Sternal Closure'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Wire closure is the intervention', 'description': 'Patients will have their sternum closed using stainless steel wires.', 'interventionNames': ['Device: Sternalock Rigid Fixation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rigid fixation', 'description': 'Patients will have their sternum closed by rigid fixation using Starnalock plates.', 'interventionNames': ['Device: Sternalock Rigid Fixation']}], 'interventions': [{'name': 'Sternalock Rigid Fixation', 'type': 'DEVICE', 'description': 'Patients will have their sternum closed by rigid fixation using Sternalock plates.', 'armGroupLabels': ['Rigid fixation', 'Wire closure is the intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Hitoshi Hirose, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}