Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT01805856
Status:
COMPLETED
Last Update Posted:
2013-03-06
First Post:
2013-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'D010878', 'term': 'Piperacillin'}, {'id': 'D002437', 'term': 'Cefazolin'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D013843', 'term': 'Thiazines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-05', 'studyFirstSubmitDate': '2013-03-05', 'studyFirstSubmitQcDate': '2013-03-05', 'lastUpdatePostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Urinary tract infection after operation with or without antimicrobial prophylaxis', 'timeFrame': '1month after operation', 'description': 'If the patients had a symptom of urinary tract infection, additional blood test and urine test were done to diagnose infection accurately.'}], 'primaryOutcomes': [{'measure': 'Surgical site infections after thyroid and parathyroid surgery', 'timeFrame': '1 month after operation', 'description': 'Surgical site infection was defined as patients who are necessary to receive the treatment such as surgical drainage or antibiotic medication. When the patients receive the surgical drainage, microbial culture was performed.'}], 'secondaryOutcomes': [{'measure': 'Side effect of the drug for Antimicrobial prophylaxis', 'timeFrame': '4 days after operation', 'description': "The appearances of drug allergic reactions (skin rash and anaphylactic shock) were checked at operating room. Blood test to check up liver and renal dysfunction was done on the 3rd POD. Liver and renal dysfunction is clinically diagnosed by patients' own physicians and the author, and only counted the cases which function got worse compared to preoperative data."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antimicrobial prophylaxis', 'AMP', 'surgical site infection', 'SSI', 'thyroid', 'thyroidectomy', 'parathyroid', 'surgery'], 'conditions': ['Thyroid Disease', 'Parathyroid Disease']}, 'descriptionModule': {'briefSummary': 'The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean neck surgery associated with thyroid and parathyroid disease.', 'detailedDescription': 'Between November 2010 and April 2012, 2164 consecutive patients who agreed to attend the randomized control study were enrolled. All the participants received surgery for thyroid and parathyroid disease at Ito Hospital and randomized in three groups; Group A (n=541): operation with AMP (PIPC, piperacillin sodium), Group B (n=541): operation with AMP (CEZ, cefazolin sodium), and Group C (n=1082): operation without AMP.\n\nExclusion criteria\n\n* Patients who did not agree to attend the randomized control study.\n* Patients who received the operation including mediastinum with sternotomy.\n* Patients who received the operation including additional resection of trachea, esophagus and larynx.\n* Patients who received the re-operation for post-operative bleedings.\n* Patients who had known allergy to cephem or penicillin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between November 2010 and April 2012, 2164 consecutive patients who agreed to attend the randomized control study were enrolled. All the participants received surgery for thyroid and parathyroid disease at Ito Hospital.\n\nExclusion Criteria:\n\n* Patients who did not agree to attend the randomized control study.\n* Patients who received the operation including mediastinum with sternotomy.\n* Patients who received the operation including additional resection of trachea, esophagus and larynx.\n* Patients who received the re-operation for post-operative bleedings.\n* Patients who had known allergy to cephem or penicillin.'}, 'identificationModule': {'nctId': 'NCT01805856', 'acronym': 'Ito-RCT1', 'briefTitle': 'Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ito Hospital'}, 'officialTitle': 'Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery', 'orgStudyIdInfo': {'id': 'Ito-RCT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (intervention PIPC)', 'description': "Patients in group A (intervention PIPC) were given AMP of 2g PIPC intravenously just after intubation. If the operation time was longer than 3 hours, additional infusion of same dose PIPC was done. After coming back to the patients' own room, one more infusion of same dose of same drug was done.", 'interventionNames': ['Drug: PIPC piperacillin sodium']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (intervention CEZ)', 'description': "Patients in Group B (intervention CEZ) were given AMP of 1g CEZ intravenously just after intubation. If the operation time was longer than 3 hours, additional infusion of same dose CEZ was done. After coming back to the patients' own room, one more infusion of same dose of same drug was done.", 'interventionNames': ['Drug: CEZ, cefazolin sodium']}, {'type': 'NO_INTERVENTION', 'label': 'Group C (without AMP)', 'description': 'Patients in Group C underwent surgery without any AMP.'}], 'interventions': [{'name': 'PIPC piperacillin sodium', 'type': 'DRUG', 'otherNames': ['PIPC, piperacillin sodium'], 'armGroupLabels': ['Group A (intervention PIPC)']}, {'name': 'CEZ, cefazolin sodium', 'type': 'DRUG', 'armGroupLabels': ['Group B (intervention CEZ)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150-8308', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Ito Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Takashi Uruno, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ito Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ito Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}