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临床试验/NCT01993134
NCT01993134Unknown2 期

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

Universidade Federal do Rio Grande do Norte2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
2 期
入组人数
75
试验地点
2
主要终点
Reduction of postoperative infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Reduction of postoperative infection

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giordano Bruno Paiva Campos

DDS

Universidade Federal do Rio Grande do Norte

研究点 (2)

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