Clinical Trial: Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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 microb

Detailed Summary:

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.

Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number
Sponsor: Silvia M. Pinango L.

Current Primary Outcome:

• Surgical Site Infection [ Time Frame: 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 [ Time Frame: 10 days ]
  Patients with complications different to surgical site infection.

Original Primary Outcome: evaluated the impact of Early short-term antibiotic therapy with Ertapenem upon clinical postoperatory evolution in patients with penetrating abdominal trauma at emergency room of Miguel Perez Carreño Hospital [ Time Frame: 10 - 12 days after surgery ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Pinango, Silvia M. L., M.D.

Dates:
Date Received: September 14, 2010
Date Started: December 2010
Date Completion:
Last Updated: August 8, 2012
Last Verified: August 2012