Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-01-01 @ 2:52 PM
Study NCT ID:
NCT04707092
Status:
UNKNOWN
Last Update Posted:
2021-10-04
First Post:
2021-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Preoperative and Postoperative Antimicrobial Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization in two treatment arms'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 304}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-01', 'studyFirstSubmitDate': '2021-01-11', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '1 month', 'description': 'Side effects from treatment with antibiotics'}], 'secondaryOutcomes': [{'measure': 'Infection of surgical site (immediate)', 'timeFrame': '1 month', 'description': 'Infection of surgical site with discharge, redness, fever'}, {'measure': 'Infection of surgical site (long term)', 'timeFrame': '2 years', 'description': 'infection of surgical site with discharge, fever, extrusion of device'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ear Infection Bacterial', 'Surgical Site Infection', 'Antibiotic Side Effect']}, 'descriptionModule': {'briefSummary': 'In this study, patients undergoing ear surgery (cochlear implantation, stapedotomy, tympanoplasty) will be randomized to one of two antibiotic treatment groups.\n\nOne group will receive a single treatment with an antibiotic at induction\n\nThe other group will receive the single intravenous treatment, plus a one week course or oral antibiotic', 'detailedDescription': '1. Patients will be asked to participate in the study.\n2. Randomization\n3. Surgery\n4. Follow-up at 1 week, 1 month patients will be asked if they filled their prescription, took the medication as prescribed, experienced any symptoms such as rash, diarrhea, nausea,.. Further the wound will be inspected for any signs of infection. Patients will also be asked if they had noticed discharge, pain, pulsating sensation\n5. Follow-up at three months, 1 year and 2 years - patients will again be asked for any signs of infections or necessary visits with their doctor due to infections'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to participate in the study\n* Undergoing standard ear surgery (Stapedotomy, cochlear implantation, tympanoplasty and tympanomastoidectomy)\n\nExclusion Criteria:\n\n* multiple allergies to antibiotic substances\n* therapy with an antibiotic substance within the last 6 weeks\n* prior radiation to the head and neck patients undergoing revision surgery\n* Any use of post-operative antibiotics (oral, intravenous, topical) for reason which do not include surgical site infection'}, 'identificationModule': {'nctId': 'NCT04707092', 'briefTitle': 'Use of Preoperative and Postoperative Antimicrobial Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Use of Preoperative and Postoperative Antimicrobial Treatment', 'orgStudyIdInfo': {'id': '3486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antibiotic at induction', 'description': 'Patients will receive one single dose of Antibiotic at induction', 'interventionNames': ['Drug: Antibiotic']}, {'type': 'EXPERIMENTAL', 'label': 'Antibiotic one week', 'description': 'Patients will receive one single dose of Antibiotic at induction, plus a 7 day treatment with oral Antibiotic', 'interventionNames': ['Drug: Antibiotic']}], 'interventions': [{'name': 'Antibiotic', 'type': 'DRUG', 'description': 'Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week', 'armGroupLabels': ['Antibiotic at induction', 'Antibiotic one week']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data will not be shared since no conclusions can be drawn from single patient data, the results will be made available in detail'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}