Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT01273818
Status:
COMPLETED
Last Update Posted:
2014-12-29
First Post:
2011-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005839', 'term': 'Gentamicins'}, {'id': 'D002437', 'term': 'Cefazolin'}], 'ancestors': [{'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gayeebru@superonline.com', 'phone': '+905323360618', 'title': 'Dr.Gaye Seker', 'organization': 'S.B.Ankara Diskapi Yildirim Beyazit Education and Teaching Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Gentamicin', 'description': 'Gentamicin arm: application of 80 mg gentamycin topically\n\nGentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose\n\nNo adverse effect', 'otherNumAtRisk': 87, 'otherNumAffected': 0, 'seriousNumAtRisk': 87, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cephazolin', 'description': 'Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery\n\nGentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose\n\nNo adverse effect', 'otherNumAtRisk': 98, 'otherNumAffected': 0, 'seriousNumAtRisk': 98, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Gentamicin+ Cefazolin Sodium', 'description': 'Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively\n\nGentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose\n\nNo adverse effect', 'otherNumAtRisk': 91, 'otherNumAffected': 0, 'seriousNumAtRisk': 91, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Post-operative Infection', 'timeFrame': 'within the first 30 days after surgery', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Infections in Each Study Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Gentamicin', 'description': 'Total number of patients to which topical gentamicin was applied for prophylaxis'}, {'id': 'OG001', 'title': 'Cefazolin IV', 'description': 'Total number of patients to which ceephazoline (İV) was applied for prophylaxis'}, {'id': 'OG002', 'title': 'Topical and iv', 'description': 'Total number of patients to which topical gentamicin and cephazoline (iv) was applied for prophylaxis'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.198', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Fscher exact test', 'ciNumSides': 'TWO_SIDED', 'estimateComment': 'we did not need an estimation parameter such as odds or relative risk because of our experimental design and hypothesis of this study.', 'groupDescription': 'Comparison Group Selection: our primary outcome is "infection positive or negative"so, we compared the frequencies of being positive infections for these three groups. Our null hypothesis is " positive infection frequencies are same for three groups". We calculated post-hoc power for this design and found 0.99 for the percentages which shows positive infections respectively for Topical Gentamicin, cefazoline iv and topical gentamicin and iv cefazolin; 2.3%, 3.1% and 0%.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'within the 30 days after surgery', 'description': 'Patients were examined on postoperative 30 days for the presence of surgical site infection.', 'unitOfMeasure': 'infections', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gentamicin', 'description': 'Gentamicin arm: application of 80 mg gentamycin topically'}, {'id': 'FG001', 'title': 'Cefazolin', 'description': 'Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery'}, {'id': 'FG002', 'title': 'Gentamicin+ Cefazolin Sodium', 'description': 'Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Recruitment period begins in Jan 2011. This period will be completed when record of minimum number participants ( according to power analysis) in each arm is completed.Location is surgery clinic of our hospital.', 'preAssignmentDetails': 'Totaly, 24 patients who were known using any kind of antibiotics for any reason just prior to surgery or just after the surgery and having history of allergic reactions to antibiotics used in this study were excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Gentamicin', 'description': 'Gentamicin arm: application of 80 mg gentamycin topically'}, {'id': 'BG001', 'title': 'Cephazolin', 'description': 'Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery'}, {'id': 'BG002', 'title': 'Gentamicin+ Cefazolin Sodium', 'description': 'Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '196', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.39', 'spread': '15.39', 'groupId': 'BG000'}, {'value': '49.60', 'spread': '13.85', 'groupId': 'BG001'}, {'value': '50.36', 'spread': '15.49', 'groupId': 'BG002'}, {'value': '50.10', 'spread': '14.85', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '259', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '300 consequtive patients were diveded into three groups randomly, but during follow-up period since 24 patients used any kind of antibiotics for reasons other than postoperative complications, only 276 patients were analyzed.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 276}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-17', 'studyFirstSubmitDate': '2011-01-10', 'resultsFirstSubmitDate': '2013-12-09', 'studyFirstSubmitQcDate': '2011-01-10', 'lastUpdatePostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-17', 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Post-operative Infection', 'timeFrame': 'within the first 30 days after surgery'}, {'measure': 'Number of Infections in Each Study Arm', 'timeFrame': 'within the 30 days after surgery', 'description': 'Patients were examined on postoperative 30 days for the presence of surgical site infection.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['inguinal hernia', 'infection prophylaxis', 'topical gentamicin'], 'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '16860624', 'type': 'BACKGROUND', 'citation': 'Pessaux P, Lermite E, Blezel E, Msika S, Hay JM, Flamant Y, Deepak V, Arnaud JP; French Associations for Surgical Research. Predictive risk score for infection after inguinal hernia repair. Am J Surg. 2006 Aug;192(2):165-71. doi: 10.1016/j.amjsurg.2006.05.003.'}, {'pmid': '16930145', 'type': 'BACKGROUND', 'citation': 'Tzovaras G, Delikoukos S, Christodoulides G, Spyridakis M, Mantzos F, Tepetes K, Athanassiou E, Hatzitheofilou C. The role of antibiotic prophylaxis in elective tension-free mesh inguinal hernia repair: results of a single-centre prospective randomised trial. Int J Clin Pract. 2007 Feb;61(2):236-9. doi: 10.1111/j.1742-1241.2006.00977.x.'}, {'pmid': '16119310', 'type': 'BACKGROUND', 'citation': 'Zuvela M, Milicevic M, Galun D, Lekic N, Basaric D, Tomic D, Petrovic M, Palibrk I. [Infection in hernia surgery]. Acta Chir Iugosl. 2005;52(1):9-26. doi: 10.2298/aci0501009z. Serbian.'}, {'pmid': '19321405', 'type': 'BACKGROUND', 'citation': 'Praveen S, Rohaizak M. Local antibiotics are equivalent to intravenous antibiotics in the prevention of superficial wound infection in inguinal hernioplasty. Asian J Surg. 2009 Jan;32(1):59-63. doi: 10.1016/S1015-9584(09)60011-7.'}, {'pmid': '16252314', 'type': 'BACKGROUND', 'citation': 'Aufenacker TJ, Koelemay MJ, Gouma DJ, Simons MP. Systematic review and meta-analysis of the effectiveness of antibiotic prophylaxis in prevention of wound infection after mesh repair of abdominal wall hernia. Br J Surg. 2006 Jan;93(1):5-10. doi: 10.1002/bjs.5186.'}, {'pmid': '20538079', 'type': 'BACKGROUND', 'citation': 'Shankar VG, Srinivasan K, Sistla SC, Jagdish S. Prophylactic antibiotics in open mesh repair of inguinal hernia - a randomized controlled trial. Int J Surg. 2010;8(6):444-7. doi: 10.1016/j.ijsu.2010.05.011. Epub 2010 Jun 9.'}, {'pmid': '15570201', 'type': 'BACKGROUND', 'citation': 'Aufenacker TJ, van Geldere D, van Mesdag T, Bossers AN, Dekker B, Scheijde E, van Nieuwenhuizen R, Hiemstra E, Maduro JH, Juttmann JW, Hofstede D, van Der Linden CT, Gouma DJ, Simons MP. The role of antibiotic prophylaxis in prevention of wound infection after Lichtenstein open mesh repair of primary inguinal hernia: a multicenter double-blind randomized controlled trial. Ann Surg. 2004 Dec;240(6):955-60; discussion 960-1. doi: 10.1097/01.sla.0000145926.74300.42.'}]}, 'descriptionModule': {'briefSummary': "Aim of this study is to measure the effectiveness of topical gentamicin to prevent post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is, if it is effective as a prophylactic agent, to compare it's effect with intra venous single dose cefazolin sodium prophylaxis.", 'detailedDescription': 'This study is a single blind prospective randomized trial. To measure and compare the effectiveness intra-operative topical gentamicin application in tension-free inguinal hernia repair in contrast to intravenous peri-operative prophylactic cefazolin sodium and combination of gentamicin and cephazolin this study is designed.\n\nThe patients are grouped randomly in to two groups:\n\n* Group1;intravenous cefazolin sodium\n* Group2;topical gentamicin\n* Group3:topical gentamicin and intravenous cefazolin sodium\n\nAs a control group we decided to use the data of control groups ( without any prophylactic agent usage ) of previous studies done in our clinic and medical data base reviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of inguinal hernia\n\nExclusion Criteria:\n\n* Femoral hernia\n* Emergency cases'}, 'identificationModule': {'nctId': 'NCT01273818', 'briefTitle': 'Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Is Topical Antibiotic Prophylaxis Effective in Lichtenstein Hernia Repair: a Comparison Study', 'orgStudyIdInfo': {'id': 'FC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'gentamicin', 'description': '80 mg gentamicin topical application intraoperatively', 'interventionNames': ['Drug: Gentamicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cefazolin', 'description': 'Application of 1000 mg cefazolin intra venously 1 hour before surgery', 'interventionNames': ['Drug: Cefazolin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'gentamicin and cefazolin', 'description': '1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively', 'interventionNames': ['Drug: Gentamicin and cefazolin']}], 'interventions': [{'name': 'Gentamicin and cefazolin', 'type': 'DRUG', 'otherNames': ['Drug: Cefazolin', 'Other names:', 'Cezol', 'Eqizolin', 'Drug: Gentamicin', 'Gensif', 'Gentamed'], 'description': '80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation', 'armGroupLabels': ['gentamicin and cefazolin']}, {'name': 'Cefazolin', 'type': 'DRUG', 'otherNames': ['Cezal', 'Eqizolin'], 'description': '1000 mg cefazolin application intravenously 1 hour before operation', 'armGroupLabels': ['Cefazolin']}, {'name': 'Gentamicin', 'type': 'DRUG', 'otherNames': ['Gensif', 'Gentamed'], 'description': '80 mg gentamicin application intraoperatively', 'armGroupLabels': ['gentamicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Diskapi Yildirim Beyazit Teaching and research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Gaye E Seker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diskapi Yildirim Beyazit Teaching and research Hospital'}, {'name': 'Duray Seker, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Diskapi Yildirim Beyazit Teaching and research Hospital'}, {'name': 'Bahattin Bayar, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Diskapi Yildirim Beyazit Teaching and research Hospital'}, {'name': 'Zafer Ergul, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Diskapi Yildirim Beyazit Teaching and research Hospital'}, {'name': 'Hakan Kulacoglu, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Diskapi Yildirim Beyazit Teaching and research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D. Surgery', 'investigatorFullName': 'Duray Seker', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}