Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-21 @ 7:52 PM
Study NCT ID:
NCT01991834
Status:
COMPLETED
Last Update Posted:
2015-04-27
First Post:
2013-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Prophylaxis in Gynecologic Laparoscopy
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': 'D002437', 'term': 'Cefazolin'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'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': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-24', 'studyFirstSubmitDate': '2013-11-18', 'studyFirstSubmitQcDate': '2013-11-22', 'lastUpdatePostDateStruct': {'date': '2015-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infection', 'timeFrame': '30 days', 'description': "Patients are followed weekly by a masked surgeon in regard to surgical site infecton (SSI), until the 30th postoperative day. Centers for Disease Control and Prevention's (CDC) criteria and classification were adopted."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laparoscopy', 'surgical wound infection', 'antibiotic prophylaxis', 'gynecologic surgical procedures'], 'conditions': ['Infection Secondary to Surgical Procedure']}, 'descriptionModule': {'briefSummary': "Laparoscopy is a surgical procedure indicated for most gynecological pathologies and presents numerous advantages over laparotomy, among them lower rates of surgical site infection and less comorbidity feverish. Despite this, the use of antibiotic prophylaxis is widely accepted and performed by most gynecologists. However, there isn't literature evidence to support the routine use of antibiotics in the prophylaxis of wound infection on laparoscopic pelvic surgery .Therefore, this study will evaluate the need for the use of antibiotic prophylaxis in gynecological laparoscopies not including opening hollow viscera.", 'detailedDescription': 'It is a clinical, prospective, double-blind, randomized study. 114 women with gynecologic disease, in which there is indication of laparoscopic surgical approach, will be consecutively select. These women will be allocated in two arms, control and study, where control group will use placebo and study will receive intravenous cephazolin. These patients will be followed for 30 days according to Centers for Disease Control and Prevention criteria.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with gynecologic disease, undergoing gynecologic laparoscopy without opening hollow viscera.\n\nExclusion Criteria:\n\n* body mass index over 30 Kg/m2\n* smoking\n* diabetes type I or II with glycated hemoglobin exceeding 6.5%\n* patients who are at surgical risk classification of the American Society of Anesthesiologists(ASA) as ASA III or higher\n* refusal to participate\n* postoperative antibiotic therapy for another indication clinical complication'}, 'identificationModule': {'nctId': 'NCT01991834', 'briefTitle': 'Antibiotic Prophylaxis in Gynecologic Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Vale do Sapucai'}, 'officialTitle': 'Antibiotic Prophylaxis in Gynecologic Laparoscopy', 'orgStudyIdInfo': {'id': 'MPFabiola'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy.', 'interventionNames': ['Procedure: gynecologic laparoscopy', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cefazolin', 'description': 'Patients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy.', 'interventionNames': ['Procedure: gynecologic laparoscopy', 'Drug: Cefazolin']}], 'interventions': [{'name': 'gynecologic laparoscopy', 'type': 'PROCEDURE', 'otherNames': ['pelvic laparoscopy', 'gynecologic laparoscopic surgery'], 'description': 'Gynecological laparoscopy without opening hollow viscera.', 'armGroupLabels': ['Cefazolin', 'Placebo']}, {'name': 'Cefazolin', 'type': 'DRUG', 'otherNames': ['Cephazolin', 'Cefazoline', 'Cephazolin Sodium for Injection', 'Kefzol'], 'description': 'Intravenous administration of 1 g of cefazolin', 'armGroupLabels': ['Cefazolin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['placebo treatment'], 'description': 'Intravenous administration of saline sterile solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37550-000', 'city': 'Pouso Alegre', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital das Clinicas Samuel Libanio', 'geoPoint': {'lat': -22.23, 'lon': -45.93639}}, {'zip': '37550-000', 'city': 'Pouso Alegre', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital e Maternidade Santa Paula', 'geoPoint': {'lat': -22.23, 'lon': -45.93639}}], 'overallOfficials': [{'name': 'Fabiola SM Campos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade do Vale do Sapucai'}, {'name': 'Daniela F Veiga, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidade do Vale do Sapucai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Vale do Sapucai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Fabiola Soares Moreira Campos', 'investigatorAffiliation': 'Universidade do Vale do Sapucai'}}}}