Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days
|ClinicalTrials.gov Identifier: NCT01203046|
Recruitment Status : Completed
First Posted : September 16, 2010
Results First Posted : July 26, 2012
Last Update Posted : August 10, 2012
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 or disease||Intervention/treatment||Phase|
|SURGICAL SITE INFECTION||Drug: Ertapenem||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||SP1 - Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days|
|Study Start Date :||December 2010|
|Primary Completion Date :||December 2010|
|Study Completion Date :||October 2011|
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.
Ertapenem 1 gr endovenous 3 or 7 days
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.
Ertapenem 1 gr endovenous 3 or 7 days
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203046
|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|