Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-31 @ 3:34 AM
Study NCT ID:
NCT01222832
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2010-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001414', 'term': 'Bacitracin'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peter.catalano@steward.org', 'phone': '617-789-5004', 'title': 'Peter catalano', 'organization': 'SEMC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'on case by case bases', 'eventGroups': [{'id': 'EG000', 'title': 'Bacitracin', 'description': 'Bacitracin soaked sponge', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 0, 'seriousNumAtRisk': 113, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline', 'description': 'Saline soaked sponge and oral antibiotics', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 0, 'seriousNumAtRisk': 113, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bacitracin', 'description': 'Bacitracin soaked sponge'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Saline soaked sponge and oral antibiotics'}], 'classes': [{'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Number of participants without infections on post-op visits 90 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bacitracin', 'description': 'Nasopore sponge soaked in Bacitracin\n\nBacitracin: Bacitracin soaked sponge'}, {'id': 'FG001', 'title': 'Saline', 'description': 'Saline soaked sponge and oral antibiotics'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bacitracin', 'description': 'Nasopore sponge soaked in Bacitracin\n\nBacitracin: Bacitracin soaked sponge'}, {'id': 'BG001', 'title': 'Saline', 'description': 'Nasopore sponge soaked in saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}], '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': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2010-10-14', 'resultsFirstSubmitDate': '2015-05-19', 'studyFirstSubmitQcDate': '2010-10-15', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-02', 'studyFirstPostDateStruct': {'date': '2010-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Infection', 'timeFrame': '90 days', 'description': 'Number of participants without infections on post-op visits 90 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Paranasal Sinus Disease']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a sponge soaked in Saline / and the administration of oral antibiotics.', 'detailedDescription': 'Same as above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient having primary or revision sinus surgery. Aged 18 years or older.Patients must have middle meatus easily identified. The type of surgery will not be influenced by the participation in this study.\n\nExclusion Criteria:\n\n* Age less then 18\n* Known sensitivity to Bacitracin\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01222832', 'briefTitle': 'Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge', 'organization': {'class': 'OTHER', 'fullName': "Steward St. Elizabeth's Medical Center of Boston, Inc."}, 'officialTitle': 'Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge After Functional Endoscopic Sinus Surgery', 'orgStudyIdInfo': {'id': '00534'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bacitracin', 'description': 'Nasopore sponge soaked in Bacitracin, no oral antibiotics', 'interventionNames': ['Drug: Bacitracin']}, {'type': 'NO_INTERVENTION', 'label': 'Saline', 'description': 'Nasopore sponge soaked in saline, routine oral antibiotics'}], 'interventions': [{'name': 'Bacitracin', 'type': 'DRUG', 'description': 'Bacitracin soaked nasopore sponge', 'armGroupLabels': ['Bacitracin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02135', 'city': 'Brighton', 'state': 'Massachusetts', 'country': 'United States', 'facility': "St. Elizabeth's Medical Center", 'geoPoint': {'lat': 42.3501, 'lon': -71.15644}}], 'overallOfficials': [{'name': 'Peter Catalano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Steward St. Elizabeth's Medical Center of Boston, Inc."}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Steward St. Elizabeth's Medical Center of Boston, Inc.", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Otolaryngology', 'investigatorFullName': 'Peter Catalano', 'investigatorAffiliation': "Steward St. Elizabeth's Medical Center of Boston, Inc."}}}}