Efficacy Assessment of Two Antibiotic Prophylaxis Regimens in Oral and Maxillofacial Trauma Surgery
NCT ID: NCT01993134
Last Updated: 2013-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
75 participants
INTERVENTIONAL
2011-12-31
2014-12-31
Brief Summary
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Detailed Description
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The 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.
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.
Descriptive 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Cefazolin
2g of Cefazolin, 20minutes before sugery. After surgery, 1g of cefazolin 06/06h.
Cefazolin
Cefazolin, 2g/IV, prior to surgery, and after surgery recieved 4 aditional doses 1g/IV of Cefazolin.
Cefazolin Single Dose
2g of Cefazolin, 20minutes before sugery. After surgery, no drugs.
Cefazolin Single Dose
Patients received 2g of Cefazolin (Cefazolin Sodium - Ampoule- 1g - Genéricos Brasil), administered intravenously but none was administered in the post-operative period
Interventions
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Cefazolin
Cefazolin, 2g/IV, prior to surgery, and after surgery recieved 4 aditional doses 1g/IV of Cefazolin.
Cefazolin Single Dose
Patients received 2g of Cefazolin (Cefazolin Sodium - Ampoule- 1g - Genéricos Brasil), administered intravenously but none was administered in the post-operative period
Eligibility Criteria
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Inclusion Criteria
* ASA I, II, III
* have facial fractures, that request surgical treatement, and whitout infection
Exclusion Criteria
* Or requiring surgery longer than six hours
15 Years
75 Years
ALL
No
Sponsors
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Universidade Federal do Rio Grande do Norte
OTHER
Responsible Party
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Giordano Bruno Paiva Campos
DDS
Principal Investigators
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Adriano Germano, PhD
Role: STUDY_CHAIR
Universidade Federal do Rio Grande do Norte
Locations
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Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital
Natal, Rio Grande do Norte, Brazil
Countries
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Facility Contacts
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Giordano Campos, DDS
Role: primary
Other Identifiers
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ATB-001
Identifier Type: -
Identifier Source: org_study_id