Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT07111702
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2025-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Antibiotics in Groin Hernioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002437', 'term': 'Cefazolin'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Surgical Site Infection (SSI)', 'timeFrame': 'Within 30 days post-surgery', 'description': 'The rate of surgical site infection diagnosed within 30 days of surgery, based on Centers for Disease Control and Prevention (CDC) clinical criteria (e.g., purulent discharge, erythema, localized pain or swelling).'}], 'secondaryOutcomes': [{'measure': 'Independent Risk Factors for Surgical Site Infection (SSI)', 'timeFrame': 'From baseline through 30 days post-surgery', 'description': 'Identification of baseline and operative variables independently associated with the development of SSI. This was assessed using a multivariable logistic regression model to calculate adjusted odds ratios for factors such as high Body Mass Index (BMI), prolonged operative time, and high American Society of Anesthesiologists (ASA) score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antibiotic Prophylaxis', 'Wound Infection', 'Risk Factors'], 'conditions': ['Surgical Site Infection', 'Groin Hernia', 'Hernioplasty']}, 'descriptionModule': {'briefSummary': "The role of prophylactic antibiotics in preventing surgical site infections (SSI) for clean procedures like groin hernia repair remains controversial. This study aimed to evaluate the association between antibiotic prophylaxis and SSI rates in a real-world clinical setting and to identify independent risk factors for SSI. The study prospectively followed 100 male patients undergoing elective open groin hernioplasty. Patients were categorized based on the surgeon's decision into two groups: those who received a single dose of intravenous cefazolin (Antibiotic Group) and those who did not (No Antibiotic Group). The main outcome was the rate of SSI within 30 days of surgery."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '17 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (aged 17-80 years) undergoing primary open groin hernioplasty.\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* Recurrent, emergency, or complicated (e.g., incarcerated, strangulated) hernias.\n* Laparoscopic repairs.\n* Known immunosuppression, ongoing antibiotic therapy, or a known allergy to cefazolin.\n* Refusal to participate.'}, 'identificationModule': {'nctId': 'NCT07111702', 'briefTitle': 'Prophylactic Antibiotics in Groin Hernioplasty', 'organization': {'class': 'OTHER', 'fullName': "Sana'a University"}, 'officialTitle': 'Prophylactic Antibiotics in Groin Hernioplasty: A Prospective Cohort Study on the Prevention of Surgical Site Infection', 'orgStudyIdInfo': {'id': 'SU-Hernia-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antibiotic Group', 'description': 'Patients received a single intravenous dose of cefazolin (2 g) 30-60 min prior to skin incision.', 'interventionNames': ['Drug: Cefazolin']}, {'type': 'NO_INTERVENTION', 'label': 'No Antibiotic Group', 'description': 'Patients did not receive antibiotic prophylaxis.'}], 'interventions': [{'name': 'Cefazolin', 'type': 'DRUG', 'description': 'A single 2g intravenous dose administered once before surgery.', 'armGroupLabels': ['Antibiotic Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sanaa', 'country': 'Yemen', 'facility': 'Al-Gumhori Teaching Hospital', 'geoPoint': {'lat': 15.35452, 'lon': 44.20646}}], 'overallOfficials': [{'name': 'Waleed Mohammed Gilan, Asssociate Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Faculty of Medicine and Health Sciences, Sana'a University"}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will be available beginning 3 months after article publication and the access period will remain open for 5 years.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data that underlie the results reported in this article will be made available after publication. This includes data on baseline characteristics, group allocation, and the primary outcome.', 'accessCriteria': 'Data will be made available to qualified researchers for meta-analysis or other secondary analyses. Researchers must submit a methodologically sound proposal to the corresponding author at h.jowah@su.edu.ye. A signed data access agreement will be required.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Sana'a University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Gumhori Teaching Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Haitham Mohammed Jowah', 'investigatorAffiliation': "Sana'a University"}}}}