Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-02-24 @ 6:02 AM
Study NCT ID:
NCT03050203
Status:
COMPLETED
Last Update Posted:
2019-01-28
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Custom Pack in Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D013120', 'term': 'Spinal Cord Neoplasms'}, {'id': 'D055013', 'term': 'Osteoarthritis, Spine'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cristiana.forni@ior.it', 'phone': '0039516366', 'title': 'Cristiana Forni', 'phoneExt': '694', 'organization': 'Istituto Ortopedico Rizzoli'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Custom Pack', 'description': 'custom pack: Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Care', 'description': 'standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Soft Tissue Dissecting Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Custom Pack', 'description': 'custom pack: Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '34', 'spread': '19.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to the first day post intervention', 'description': 'minutes from the start of the dissection to complete bone cleaning', 'unitOfMeasure': 'minues', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgery Time', 'timeFrame': 'up to the first day post intervention', 'description': "from the incision to the patient's sutures (minutes)", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Postoperative Complications', 'timeFrame': 'up to 2 weeks', 'description': 'number of early wound infection', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Numbers of Materials Wasted', 'timeFrame': 'up to the first day post intervention', 'description': 'amount of open sterile materials not used', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Blood Loss', 'timeFrame': 'up to 2 weeks', 'description': 'Levels of hemoglobin and hematocrit intraoperative (gas analysis before and after surgery) compared to hemoglobin and hematocrit before surgery and number of blood transfusions both intra- and postoperative.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Pain (Score on the "Numeric Rating Scale")', 'timeFrame': 'up to the first 3 days post intervention', 'description': 'Pain Score on the "Numeric Rating Scale". The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'timeFrame': 'up to 2 weeks', 'description': 'number of days spent in hospital', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Custom Pack', 'description': 'custom pack: Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.'}, {'id': 'FG001', 'title': 'Standard Care', 'description': 'standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Custom Pack', 'description': 'custom pack: Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.'}, {'id': 'BG001', 'title': 'Standard Care', 'description': 'standard care: The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51.1', 'spread': '16.7', 'groupId': 'BG000'}, {'value': '54.8', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '53', 'spread': '14.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'degenerative disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2017-02-01', 'resultsFirstSubmitDate': '2018-08-08', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-08', 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Soft Tissue Dissecting Time', 'timeFrame': 'up to the first day post intervention', 'description': 'minutes from the start of the dissection to complete bone cleaning'}], 'secondaryOutcomes': [{'measure': 'Surgery Time', 'timeFrame': 'up to the first day post intervention', 'description': "from the incision to the patient's sutures (minutes)"}, {'measure': 'Postoperative Complications', 'timeFrame': 'up to 2 weeks', 'description': 'number of early wound infection'}, {'measure': 'Numbers of Materials Wasted', 'timeFrame': 'up to the first day post intervention', 'description': 'amount of open sterile materials not used'}, {'measure': 'Blood Loss', 'timeFrame': 'up to 2 weeks', 'description': 'Levels of hemoglobin and hematocrit intraoperative (gas analysis before and after surgery) compared to hemoglobin and hematocrit before surgery and number of blood transfusions both intra- and postoperative.'}, {'measure': 'Pain (Score on the "Numeric Rating Scale")', 'timeFrame': 'up to the first 3 days post intervention', 'description': 'Pain Score on the "Numeric Rating Scale". The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain.'}, {'measure': 'Length of Stay', 'timeFrame': 'up to 2 weeks', 'description': 'number of days spent in hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Diseases', 'Spine Cancer', 'Spine Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Recent evidence suggests the efficacy of "custom pack" procedure on the operators reduction time and on the contamination risk due to the opening of many sterile packs. Nevertheless ,the studies available are sponsored by the industry and their results are very few. The aim of this study is to evaluate the correlation and reliability of spine surgery "custom pack" efficacy in adult patients obtained in the reduction of surgery time, relative risks, and materials wasted compared with the standard surgical field procedure practice .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Degenerative spinal disease from 2 to 4 levels,\n* Oncologic spine disease with only decompression and stabilization.\n\nExclusion Criteria:\n\n* Revision surgeries,\n* Minimally invasive interventions,\n* Interventions that provide a dual access, and\n* Patients who refuse consent to experimentation.'}, 'identificationModule': {'nctId': 'NCT03050203', 'acronym': 'kit', 'briefTitle': 'Custom Pack in Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': "Surgical Field Custom Pack's Efficacy on Soft Tissue Dissecting Time Reduction, on Relative Risks and Materials Wasted, in Patients Undergoing Spine Surgery: Randomized Controlled Trial", 'orgStudyIdInfo': {'id': '0033168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'custom pack', 'interventionNames': ['Other: custom pack']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard care', 'interventionNames': ['Other: standard care']}], 'interventions': [{'name': 'custom pack', 'type': 'OTHER', 'description': 'Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.', 'armGroupLabels': ['custom pack']}, {'name': 'standard care', 'type': 'OTHER', 'description': 'The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery', 'armGroupLabels': ['standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Annamaria Nicolini, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Ortopedico Rizzoli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}