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Efficacy Assessment of Two Antibiotic Prophylaxis Regimens in Oral and Maxillofacial Trauma Surgery (EAPRTS)

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ClinicalTrials.gov Identifier: NCT01993134
Recruitment Status : Unknown
Verified November 2013 by Giordano Bruno Paiva Campos, Universidade Federal do Rio Grande do Norte.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Giordano Bruno Paiva Campos, Universidade Federal do Rio Grande do Norte

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Facial Fractures Procedure: Cefazolin Procedure: Cefazolin Single Dose Phase 2

Detailed Description:

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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Efficacy Assessment of Two Antibiotic Prophylaxis Regimens in Oral and Maxillofacial Trauma Surgery.
Study Start Date : December 2011
Actual Primary Completion Date : November 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Cefazolin
2g of Cefazolin, 20minutes before sugery. After surgery, 1g of cefazolin 06/06h.
Procedure: Cefazolin
Cefazolin, 2g/IV, prior to surgery, and after surgery recieved 4 aditional doses 1g/IV of Cefazolin.

Active Comparator: Cefazolin Single Dose
2g of Cefazolin, 20minutes before sugery. After surgery, no drugs.
Procedure: 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




Primary Outcome Measures :
  1. Reduction of postoperative infection [ Time Frame: 45 days ]
    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.



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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Both genders
  • ASA I, II, III
  • have facial fractures, that request surgical treatement, and whitout infection

Exclusion Criteria:

  • Patients with pan-facial fractures
  • Or requiring surgery longer than six hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993134


Locations
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Brazil
Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital Recruiting
Natal, Rio Grande do Norte, Brazil, 59012-300
Contact: Giordano Campos, DDS    +558491015536    giordano_campos@hotmail.com   
Principal Investigator: Adriano Germano, PhD         
Sub-Investigator: Giordano Campos, DDS         
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Investigators
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Study Chair: Adriano Germano, PhD Universidade Federal do Rio Grande do Norte
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Responsible Party: Giordano Bruno Paiva Campos, DDS, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT01993134    
Other Study ID Numbers: ATB-001
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Giordano Bruno Paiva Campos, Universidade Federal do Rio Grande do Norte:
Postoperative infection
Antibiotic prophylaxis
Cefazolin
Additional relevant MeSH terms:
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Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents