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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Silvia M. Pinango L., Pinango, Silvia M. L., M.D.
ClinicalTrials.gov Identifier:
NCT01203046
First received: September 14, 2010
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
SURGICAL SITE INFECTION
Drug: Ertapenem
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: SP1 - Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days

Resource links provided by NLM:


Further study details as provided by Pinango, Silvia M. L., M.D.:

Primary Outcome Measures:
  • Surgical Site Infection [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Patients with complications different to surgical site infection.


Enrollment: 56
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GROUP A: 7 DAYS ANTIBIOTIC THERAPY
Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the during the next 7 days after surgery.
Drug: Ertapenem
Ertapenem 1 gr endovenous 3 or 7 days
Other Names:
  • Invanz
  • Early antibiotic therapy
Experimental: GROUP B - 3 DAYS ANTIBIOTIC THERAPY
Ertapenem will be administrated within the first 2 hours of Hospital´s admission and during the next 3 days after surgery.
Drug: Ertapenem
Ertapenem 1 gr endovenous 3 or 7 days
Other Names:
  • Invanz
  • Early antibiotic therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203046

Sponsors and Collaborators
Silvia M. Pinango L.
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: SILVIA M. PIÑANGO, MD IVSS Dr. MIGUEL PEREZ CARREÑO HOSPITAL
Study Chair: LUIS R. LEVEL, MD FACS IVSS Dr. MIGUEL PEREZ CARREÑO HOSPITAL
  More Information

Publications:

Responsible Party: Silvia M. Pinango L., Pinango L, Silvia M., Pinango, Silvia M. L., M.D.
ClinicalTrials.gov Identifier: NCT01203046     History of Changes
Other Study ID Numbers: SP 01
Study First Received: September 14, 2010
Results First Received: February 10, 2012
Last Updated: August 8, 2012
Health Authority: Venezuela: Ministry of Health and Social Development

Keywords provided by Pinango, Silvia M. L., M.D.:
DURATION OF THERAPY
PENETRATING ABDOMINAL TRAUMA

Additional relevant MeSH terms:
Abdominal Injuries
Wounds and Injuries
Anti-Bacterial Agents
Ertapenem
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 18, 2014