Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 3:01 PM
Study NCT ID:
NCT01566734
Status:
COMPLETED
Last Update Posted:
2012-10-15
First Post:
2012-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cefazolin and Normal Saline Irrigation on Surgical Site Infections (SSIs)
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': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-12', 'studyFirstSubmitDate': '2012-03-26', 'studyFirstSubmitQcDate': '2012-03-28', 'lastUpdatePostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SSI', 'timeFrame': 'one week after discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Surgical Wound Infection', 'cefazolin', 'Cesarean Section'], 'conditions': ['Surgical Site Infections']}, 'descriptionModule': {'briefSummary': 'This study conducted to assess the effects of normal saline or cefazolin irrigation on the incidence of SSIs.\n\nHypothesis:\n\nNormal saline or cefazolin irrigation decreases the incidence of SSIs.', 'detailedDescription': 'All pregnant women who underwent cesarean after 6 hours passed their rupture of membrane and attended to Shariati Hospital of Bandarabbass were eligible for our study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women\n* 6 hours passed their rupture of membrane\n* needed to undergo cesarean\n\nExclusion Criteria:\n\n* allergy to penicillin\n* allergy to cefazolin\n* history of immunosuppressive drug use\n* gestational diabetes mellitus\n* preeclampsia'}, 'identificationModule': {'nctId': 'NCT01566734', 'briefTitle': 'Effect of Cefazolin and Normal Saline Irrigation on Surgical Site Infections (SSIs)', 'organization': {'class': 'OTHER', 'fullName': 'Hormozgan University of Medical Sciences'}, 'officialTitle': 'Comparison of the Effect of Cefazolin and Normal Saline Irrigation With no Irrigation on the Incidence of Surgical Site Infections', 'orgStudyIdInfo': {'id': 'U1111-1128-4677'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cefazolin', 'description': 'after the surgery and before closing up the patients, 2 grams of cefazolin in 5 cc of distilled water was used to irrigate the patients', 'interventionNames': ['Other: Cefazolin irrigation']}, {'type': 'EXPERIMENTAL', 'label': 'Normal Saline', 'description': 'after the surgery and before closing up the patients, 150 cc of normal saline was used to irrigate the patients', 'interventionNames': ['Other: Normal Saline Irrigation']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Cefazolin irrigation', 'type': 'OTHER', 'otherNames': ['cephazolin', 'cefazoline', 'Ancef', 'Cefacidal', 'Cefamezin', 'Cefrina', 'Elzogram', 'Faxilen', 'Gramaxin', 'Kefazol', 'Kefol', 'Kefzolan', 'Kezolin', 'Novaporin', 'Reflin', 'Zinol', 'Zolicef'], 'description': 'after the surgery and before closing up the patients, 2 grams of cefazolin in 5 cc of distilled water was used to irrigate the patients', 'armGroupLabels': ['Cefazolin']}, {'name': 'Normal Saline Irrigation', 'type': 'OTHER', 'otherNames': ['sodium chloride', 'saline solution'], 'description': 'after the surgery and before closing up the patients, 150 cc of normal saline was used to irrigate the patients and in the last group', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79176', 'city': 'Bandar Abbas', 'state': 'Hormozgan', 'country': 'Iran', 'facility': 'Shariati Hospital', 'geoPoint': {'lat': 27.1865, 'lon': 56.2808}}], 'overallOfficials': [{'name': 'Maryam Rahmani, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hormozgan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hormozgan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mohammad Esmaeil Shahrzad', 'investigatorFullName': 'Mohammad E Shahrzad, MD', 'investigatorAffiliation': 'Hormozgan University of Medical Sciences'}}}}