Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days
Condition: SURGICAL SITE INFECTION
MeSH terms: Surgical Wound Infection; Abdominal Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

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 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.
    

Detailed description: 
      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 into this trial.

      Group A treatment will be continued with Ertapenem until 7th day. Group B antibiotic therapy
      will be stopped.

      Patients follow up will be done during the first 10 days after trauma in two phases:

        1. First 7 days patients will be controlled by a daily evaluation and the data will be
           recorded according to variables in the control sheet (Appendix 3).

        2. Patients with evolution as follows, will be treated under medical criteria and cultures
           results:

             1. Temperature 38,5 °C or higher more than 24 hours within the first 7 postoperatory
                days.

             2. Sustained WBC count higher than 14,000 or increase after 48 hrs. Postoperatory.

             3. Postoperatory complications such as gastric or intestinal fistula, purulent
                drainage, intrabdominal abscess.

        3. On day 10 a new evaluation of patients will be performed and recorded in the control
           sheet (Appendix 4).

      Evaluation variables. Information will be recorded by full register of standard control
      sheets which includes: admittance date, medical history number, age, sex, clinical
      conditions, associated comorbidity, surgical findings, time since trauma, surgery time, and
      starting time of antibiotic administration (Appendix 1).

      Penetrating abdominal trauma scale will be applied in order to determine the seriousness of
      trauma and its potential general echoes (Appendix 2).

      During the postoperatory period the control sheet will include: WBC count, albumin,
      lymphocyte, local conditions of the surgical wound and penetration site wound at the
      abdominal wall, complications(Appendix 3).

      After patient discharge, they will be appointed and evaluated 10 to 12 days after surgery and
      the following items will be recorded: local conditions of the surgical wound, and penetration
      site wound, complications. (Appendix 4).

      Data from excluded patients will be recorded by exclusion causes and their evolution
      (Appendix 5). Result of sample cultures taken during surgery and its antibiogram will be
      reported (Appendix 6).

      Operations plan timetable

        1. Problem identification request and project design. October 2009 - Feb 2010.

        2. Authorization request to the Bioethics Board of "Dr. Miguel Perez Carreño" Hospital. Feb
           2010.

        3. Authorization request to the Technical Commission of "Dr. Miguel Perez Carreño"
           Hospital. Feb 2010

        4. Development and execution. Feb Nov - 2010.

        5. Data analysis. November 2010.

        6. Presentation and introduction for publication.

      Data processing analysis.

      To establish non-inferiority of the use of the therapy with ertapenem between three days
      versus 7 days of treatment, was considered a significance level of 5%, 95% confidence
      interval, a power of 80% and in the group control of 60%, a margin of not less 10% is
      considered of no clinical importance. For a balanced design of type n1 = n2 r = 1. Still
      needed 26 patients per group. The period of advance recruitment of patients was 6 months.

      Ethical aspects. It will be required and informed consent to individuals whom enter to this
      study, after explaining to them what is all about, the benefits and the possible risks, they
      wil be asked for their signatures or the signatures of closest relatives at the entrance
      time. (Appendix 6).
    

Intervention name(s): Ertapenem
Intervention type(s): Drug
Intervention description(s): Ertapenem 1 gr endovenous 3 or 7 days
Other intervention name(s): Invanz; Early antibiotic therapy
Intervention MeSH terms: Anti-Bacterial Agents; Ertapenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: DURATION OF THERAPY; PENETRATING ABDOMINAL TRAUMA