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

Efficacy Assessment of Two Antibiotic Prophylaxis Regimens in Oral and Maxillofacial Trauma Surgery.

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.

Study Overview

• Status: Unknown
• Conditions: Facial Fractures
• Intervention / Treatment: Procedure: Cefazolin; Procedure: Cefazolin Single Dose

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59012-300
      • Recruiting
      • Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital
      • Contact: Giordano Campos, DDS; Phone Number: +558491015536; Email: giordano_campos@hotmail.com
      • Principal Investigator: Adriano Germano, PhD
      • Sub-Investigator: Giordano Campos, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of postoperative infection	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.	45 days

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte
• Investigators: Study Chair: Adriano Germano, PhD, Universidade Federal do Rio Grande do Norte

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 18, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Antibiotic prophylaxis; Cefazolin; Postoperative infection
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: ATB-001