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临床试验/NCT01203046
NCT01203046已完成2 期

SP1 - Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days

Silvia M. Pinango L.0 个研究点目标入组 56 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
56
主要终点
Surgical Site Infection

研究概览

简要总结

Abdominal penetrating trauma represents a frequent cause of consult into emergency rooms in Venezuela. Accidents and violence at Hospital "Miguel Perez Carreño" along april 2009 were represented by gunshots and stabbing wounds which 8th. and 18th cause for medical attention respectively within a total of 76 cases. Likewise gunshot wounds reach the first cause of morbility into general surgery services with 21 cases and the stabbing wounds the 12th cause with 12 cases within the same period.

Early therapy is defined as the antibiotic dose administrated within the first 12 hours after the trauma. Abdominal cavity contamination by micro-organism is not synonymous of stablished infection, the extension of contamination and intensity of reaction should be enough in order to allow the inflammatory focus developing.

Abdominal cavity needs at least 12 - 24 hours of exposure to the infectious material to allow the stablishment of such infection. Origin and amount of contaminant material influence the size of inoculated bacteria and the speed that infection develops.

There is not an absolute criteria to determine when intrabdominal contamination progress to an established infection. Surgeons decides the must adequated therapy according to clinical history, radiology tests and findings during surgery.

Selected patients for early antibiotic therapy in penetrating abdominal trauma includes those with traumatic intestinal wounds with less than 12 hours of evolution and those with gastroduodenal wounds lesser than 24 hours as well.

There are different antibiotics indicated for intrabdominal infections. Ertapenem is a low resistance carbapenem with a broad spectrum into microbial flora presenting in penetrating abdominal trauma. Its media life and blood therapeutic levels allows the use of an unique dose within the first 24 hours of trauma.

This research protocol has been designed according to established patterns for clinical investigation and our goal is to achieve criteria in decision making about antibiotic administration in patients with penetrating abdominal trauma and evaluate the security of an Early short term antibiotic therapy with Ertapenem 3 days vs 7 days, decreasing hospital costs related to indiscriminate use of antibiotics.

详细描述

General objectives The object of this research is to evaluated the impact of Early short-term antibiotic therapy with Ertapenem, 3 vs 7 days, upon clinical postoperatory evolution in patients with penetrating abdominal trauma at emergency room of "Miguel Perez Carreño" Hospital

Specific objectives

  1. To determine the incidence of postoperatory infectious complications in patients with penetrating abdominal trauma under Early short term antibiotic therapy with Ertapenem.
  2. To establish the efficacy of Early short term antibiotic therapy 3 days with Ertapenem versus systematic administration of the same antibiotic up to the 7th day after surgery in order to prevent postoperatory infections.
  3. To identify the risk factors that predispose the appearance of infectious complications in patients with penetrating abdominal trauma.

Investigation type This will be a prospective, comparative, double blind, randomized, experimental clinical trial in patients with penetrating abdominal trauma, who attend the emergency room of Dr. "Miguel Perez Carreño" Hospital between February and July 2010.

Therapy. Surgery will be perform within a period no longer than twelve hours since time of trauma. Culture samples from abdominal cavity will be taken during the surgery in order to identify the bacterial prevalence and its sensibility to antibiotics.

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
None

入排标准

年龄范围
12 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with penetrating abdominal trauma who attended the emergency room within 12 hours after trauma, admitted to an exploratory laparotomy.
  • Patients aged 12 to 65 years.

排除标准

  • Clinical history of immunologic diseases, cancer, use of immunosuppressors, steroids, malnutrition, morbid obesity.
  • Concomitant pathology at admittance: urinary infections, respiratory infections, hepatitis, viral diseases.
  • Associated open bone fractures.
  • Patients with hemodynamic instability during pre or peroperative.

研究组 & 干预措施

GROUP A: 7 DAYS ANTIBIOTIC THERAPY

Active Comparator

Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the during the next 7 days after surgery.

干预措施: Ertapenem (Drug)

GROUP B - 3 DAYS ANTIBIOTIC THERAPY

Experimental

Ertapenem will be administrated within the first 2 hours of Hospital´s admission and during the next 3 days after surgery.

干预措施: Ertapenem (Drug)

结局指标

主要结局

Surgical Site Infection

时间窗: 10 days

The patients were evaluated up to 10 days with close observation of surgical site. We concluded as surgical site infection when inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption was observed.

Other Complications

时间窗: 10 days

Patients with complications different to surgical site infection.

次要结局

未报告次要终点

研究者

发起方
Silvia M. Pinango L.
申办方类型
Indiv
责任方
Sponsor Investigator
主要研究者

Silvia M. Pinango L.

Pinango L, Silvia M.

Pinango, Silvia M. L., M.D.

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