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

Primary Purpose

SURGICAL SITE INFECTION

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ertapenem
Sponsored by
Silvia M. Pinango L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SURGICAL SITE INFECTION focused on measuring DURATION OF THERAPY, PENETRATING ABDOMINAL TRAUMA

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    GROUP A: 7 DAYS ANTIBIOTIC THERAPY

    GROUP B - 3 DAYS ANTIBIOTIC THERAPY

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Surgical Site Infection
    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
    Patients with complications different to surgical site infection.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 14, 2010
    Last Updated
    August 8, 2012
    Sponsor
    Silvia M. Pinango L.
    Collaborators
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01203046
    Brief Title
    Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days
    Official Title
    SP1 - Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Silvia M. Pinango L.
    Collaborators
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 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 To determine the incidence of postoperatory infectious complications in patients with penetrating abdominal trauma under Early short term antibiotic therapy with Ertapenem. 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. 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: 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). Patients with evolution as follows, will be treated under medical criteria and cultures results: Temperature 38,5 °C or higher more than 24 hours within the first 7 postoperatory days. Sustained WBC count higher than 14,000 or increase after 48 hrs. Postoperatory. Postoperatory complications such as gastric or intestinal fistula, purulent drainage, intrabdominal abscess. 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 Problem identification request and project design. October 2009 - Feb 2010. Authorization request to the Bioethics Board of "Dr. Miguel Perez Carreño" Hospital. Feb 2010. Authorization request to the Technical Commission of "Dr. Miguel Perez Carreño" Hospital. Feb 2010 Development and execution. Feb Nov - 2010. Data analysis. November 2010. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SURGICAL SITE INFECTION
    Keywords
    DURATION OF THERAPY, PENETRATING ABDOMINAL TRAUMA

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GROUP A: 7 DAYS ANTIBIOTIC THERAPY
    Arm Type
    Active Comparator
    Arm Description
    Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the during the next 7 days after surgery.
    Arm Title
    GROUP B - 3 DAYS ANTIBIOTIC THERAPY
    Arm Type
    Experimental
    Arm Description
    Ertapenem will be administrated within the first 2 hours of Hospital´s admission and during the next 3 days after surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Ertapenem
    Other Intervention Name(s)
    Invanz, Early antibiotic therapy
    Intervention Description
    Ertapenem 1 gr endovenous 3 or 7 days
    Primary Outcome Measure Information:
    Title
    Surgical Site Infection
    Description
    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.
    Time Frame
    10 days
    Title
    Other Complications
    Description
    Patients with complications different to surgical site infection.
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SILVIA M. PIÑANGO, MD
    Organizational Affiliation
    IVSS Dr. MIGUEL PEREZ CARREÑO HOSPITAL
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    LUIS R. LEVEL, MD FACS
    Organizational Affiliation
    IVSS Dr. MIGUEL PEREZ CARREÑO HOSPITAL
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
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    1754794
    Citation
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