Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-06 @ 9:56 AM
Study NCT ID:
NCT01993134
Status:
UNKNOWN
Last Update Posted:
2013-11-25
First Post:
2013-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Assessment of Two Antibiotic Prophylaxis Regimens in Oral and Maxillofacial Trauma Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2013-11-11', 'studyFirstSubmitQcDate': '2013-11-18', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of postoperative infection', 'timeFrame': '45 days', 'description': 'Post-operative follow up was conducted in the 1st, 2nd, 4th and 6th weeks. The criteria used to determine the presence of infection were: a) pus drainage at the fracture site or in the vicinity of the surgical intervention site; b) increased swelling 7 days after the operation; c) presence of a fistula in the area of the surgical intervention or at the site of the fracture, with active drainage; d) other clinical features observed by the evaluator including typical signs of infection such as fever, edema, and localized redness.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postoperative infection', 'Antibiotic prophylaxis', 'Cefazolin'], 'conditions': ['Facial Fractures']}, 'descriptionModule': {'briefSummary': 'The study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients with facial fractures admitted to the Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital attached to the Federal University of Rio Grande do Norte.', 'detailedDescription': 'The study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients with facial fractures admitted to the Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital attached to the Federal University of Rio Grande do Norte.This clinical study was prospective, randomized and controlled. Patients underwent surgery for facial fracture reduction and fixation under general anesthetic. Prior to surgery, patients were randomly divided into two groups. Group 1 patients each received 2g of Cefazolin (Cefazolin Sodium - Ampoule- 1g - Genéricos Brasil), administered intravenously but none was administered in the post-operative period. Group II patients received the same dose prior to the operation but in the post-operative period they also received 4 additional 1 g doses of Cefazolin intravenously, completing a 24 period of antibiotic prophylaxis. In the case of operations that lasted for more than 4 hours, an additional 1g dose was given.\n\nThe surgical operations involved intra and extra-oral interventions and when required internal rigid fixation was undertaken using titanium plates and screws. Patients were given advice on oral hygiene procedures to be followed in the post-operative period that included chlorhexidine (0.12%) oral rinses and care to be taken with the surgical wounds.\n\nPost-operative follow up was conducted in the 1st, 2nd, 4th and 6th weeks. The criteria used to determine the presence of infection were: a) pus drainage at the fracture site or in the vicinity of the surgical intervention site; b) increased swelling 7 days after the operation; c) presence of a fistula in the area of the surgical intervention or at the site of the fracture, with active drainage; d) other clinical features observed by the evaluator including typical signs of infection such as fever, edema, and localized redness.\n\nDescriptive analysis was made of the independent variables, namely, age, sex, presence of systemic diseases, trauma cause, drug use (tobacco, alcohol, marijuana, crack, cocaine , etc.), the time lapse between the trauma event and the surgical operation, length of the operation, and the measures adopted when infections were detected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders\n* ASA I, II, III\n* have facial fractures, that request surgical treatement, and whitout infection\n\nExclusion Criteria:\n\n* Patients with pan-facial fractures\n* Or requiring surgery longer than six hours'}, 'identificationModule': {'nctId': 'NCT01993134', 'acronym': 'EAPRTS', 'briefTitle': 'Efficacy Assessment of Two Antibiotic Prophylaxis Regimens in Oral and Maxillofacial Trauma Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio Grande do Norte'}, 'officialTitle': 'Efficacy Assessment of Two Antibiotic Prophylaxis Regimens in Oral and Maxillofacial Trauma Surgery.', 'orgStudyIdInfo': {'id': 'ATB-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cefazolin', 'description': '2g of Cefazolin, 20minutes before sugery. After surgery, 1g of cefazolin 06/06h.', 'interventionNames': ['Procedure: Cefazolin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cefazolin Single Dose', 'description': '2g of Cefazolin, 20minutes before sugery. After surgery, no drugs.', 'interventionNames': ['Procedure: Cefazolin Single Dose']}], 'interventions': [{'name': 'Cefazolin', 'type': 'PROCEDURE', 'description': 'Cefazolin, 2g/IV, prior to surgery, and after surgery recieved 4 aditional doses 1g/IV of Cefazolin.', 'armGroupLabels': ['Cefazolin']}, {'name': 'Cefazolin Single Dose', 'type': 'PROCEDURE', 'description': 'Patients received 2g of Cefazolin (Cefazolin Sodium - Ampoule- 1g - Genéricos Brasil), administered intravenously but none was administered in the post-operative period', 'armGroupLabels': ['Cefazolin Single Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59012-300', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Giordano Campos, DDS', 'role': 'CONTACT', 'email': 'giordano_campos@hotmail.com', 'phone': '+558491015536'}, {'name': 'Adriano Germano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Giordano Campos, DDS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}], 'overallOfficials': [{'name': 'Adriano Germano, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidade Federal do Rio Grande do Norte'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio Grande do Norte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS', 'investigatorFullName': 'Giordano Bruno Paiva Campos', 'investigatorAffiliation': 'Universidade Federal do Rio Grande do Norte'}}}}