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

NCT01993134 | Unknown Phase 2 DMC

• 1 other identifier: ATB-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Fractures

Keywords

Postoperative infection; Antibiotic prophylaxis; Cefazolin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cefazolin

EXPERIMENTAL

2g of Cefazolin, 20minutes before sugery. After surgery, 1g of cefazolin 06/06h.

Procedure: Cefazolin

Cefazolin Single Dose

ACTIVE COMPARATOR

2g of Cefazolin, 20minutes before sugery. After surgery, no drugs.

Procedure: Cefazolin Single Dose

Interventions

Cefazolin PROCEDURE

Cefazolin, 2g/IV, prior to surgery, and after surgery recieved 4 aditional doses 1g/IV of Cefazolin.

Cefazolin

Cefazolin Single Dose PROCEDURE

Patients received 2g of Cefazolin (Cefazolin Sodium - Ampoule- 1g - Genéricos Brasil), administered intravenously but none was administered in the post-operative period

Cefazolin Single Dose

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital

Natal, Rio Grande do Norte, 59012-300, Brazil

RECRUITING

MeSH Terms

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Adriano Germano, PhD

  Universidade Federal do Rio Grande do Norte

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2014
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

BR (1)