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

NCT01203046 | Completed Phase 2 Results

• 1 other identifier: SP 01
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

SURGICAL SITE INFECTION

Keywords

DURATION OF THERAPY; PENETRATING ABDOMINAL TRAUMA

Outcome Measures

Primary Outcomes (2)

• 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.

  10 days

• Other Complications

  Patients with complications different to surgical site infection.

  10 days

Study Arms (2)

GROUP A: 7 DAYS ANTIBIOTIC THERAPY

ACTIVE COMPARATOR

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

Drug: Ertapenem

GROUP B - 3 DAYS ANTIBIOTIC THERAPY

EXPERIMENTAL

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

Drug: Ertapenem

Interventions

Ertapenem DRUG

Ertapenem 1 gr endovenous 3 or 7 days

Also known as: Invanz, Early antibiotic therapy

GROUP A: 7 DAYS ANTIBIOTIC THERAPY; GROUP B - 3 DAYS ANTIBIOTIC THERAPY

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silvia M. Pinango L.: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (14)

• Dellinger EP. Antibiotic prophylaxis in trauma: penetrating abdominal injuries and open fractures. Rev Infect Dis. 1991 Sep-Oct;13 Suppl 10:S847-57. doi: 10.1093/clinids/13.supplement_10.s847.

  PMID: 1754794 BACKGROUND

• Kirton OC, O'Neill PA, Kestner M, Tortella BJ. Perioperative antibiotic use in high-risk penetrating hollow viscus injury: a prospective randomized, double-blind, placebo-control trial of 24 hours versus 5 days. J Trauma. 2000 Nov;49(5):822-32. doi: 10.1097/00005373-200011000-00006.

  PMID: 11086771 BACKGROUND

• Bozorgzadeh A, Pizzi WF, Barie PS, Khaneja SC, LaMaute HR, Mandava N, Richards N, Noorollah H. The duration of antibiotic administration in penetrating abdominal trauma. Am J Surg. 1999 Feb;177(2):125-31. doi: 10.1016/s0002-9610(98)00317-1.

  PMID: 10204554 BACKGROUND

• Schnuriger B, Inaba K, Eberle BM, Wu T, Talving P, Bukur M, Belzberg H, Demetriades D. Microbiological profile and antimicrobial susceptibility in surgical site infections following hollow viscus injury. J Gastrointest Surg. 2010 Aug;14(8):1304-10. doi: 10.1007/s11605-010-1231-x. Epub 2010 May 25.

  PMID: 20499202 BACKGROUND

• de Lalla F. Antimicrobial chemotherapy in the control of surgical infectious complications. J Chemother. 1999 Dec;11(6):440-5. doi: 10.1179/joc.1999.11.6.440.

  PMID: 10678785 BACKGROUND

• Borbone S, Cascone C, Santagati M, Mezzatesta ML, Stefani S. Bactericidal activity of ertapenem against major intra-abdominal pathogens. Int J Antimicrob Agents. 2006 Nov;28(5):396-401. doi: 10.1016/j.ijantimicag.2006.07.018. Epub 2006 Oct 11.

  PMID: 17045463 BACKGROUND

• Girgin S, Gedik E, Uysal E, Tacyildiz IH. Independent risk factors of morbidity in penetrating colon injuries. Ulus Travma Acil Cerrahi Derg. 2009 May;15(3):232-8.

  PMID: 19562544 BACKGROUND

• Salim A, Teixeira PG, Inaba K, Brown C, Browder T, Demetriades D. Analysis of 178 penetrating stomach and small bowel injuries. World J Surg. 2008 Mar;32(3):471-5. doi: 10.1007/s00268-007-9350-6.

  PMID: 18196326 BACKGROUND

• Morales CH, Villegas MI, Villavicencio R, Gonzalez G, Perez LF, Pena AM, Vanegas LE. Intra-abdominal infection in patients with abdominal trauma. Arch Surg. 2004 Dec;139(12):1278-85; discussion 1285. doi: 10.1001/archsurg.139.12.1278.

  PMID: 15611450 BACKGROUND

• Oreskovich MR, Dellinger EP, Lennard ES, Wertz M, Carrico CJ, Minshew BH. Duration of preventive antibiotic administration for penetrating abdominal trauma. Arch Surg. 1982 Feb;117(2):200-5. doi: 10.1001/archsurg.1982.01380260068012.

  PMID: 7055433 BACKGROUND

• Farre Rovira R, Frasquet Pons I, Ibor Pica JF. [Postoperative complications in malnourished patients: economic impact and predictive value of some nutritional indicators]. Nutr Hosp. 1998 Sep-Oct;13(5):233-9. Spanish.

  PMID: 9830844 BACKGROUND

• Scheunemann L, Wazlawik E, Bastos JL, Ristow Cardinal T, Mayumi Nakazora L. Agreement and association between the phase angle and parameters of nutritional status assessment in surgical patients. Nutr Hosp. 2011 May-Jun;26(3):480-7. doi: 10.1590/S0212-16112011000300008.

  PMID: 21892564 BACKGROUND

• Pull ter Gunne AF, Skolasky RL, Ross H, van Laarhoven CJ, Cohen DB. Influence of perioperative resuscitation status on postoperative spine surgery complications. Spine J. 2010 Feb;10(2):129-35. doi: 10.1016/j.spinee.2009.10.002. Epub 2009 Nov 14.

  PMID: 19914877 BACKGROUND

• Cheadle WG. Risk factors for surgical site infection. Surg Infect (Larchmt). 2006;7 Suppl 1:S7-11. doi: 10.1089/sur.2006.7.s1-7.

  PMID: 16834549 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Presented limitations because patients with penetrating abdominal trauma usually had associated bone fractures or haemodynamic instability.Identifying other predisposing factors is not reached since the sample size was restricted to only two groups.

Results Point of Contact

• Title: Dr. Silvia M. Pinango L.
• Organization: Dr. Silvia M. Pinango L

pinangosilvia@yahoo.com

+584169267988

Study Officials

• SILVIA M. PIÑANGO, MD

  IVSS Dr. MIGUEL PEREZ CARREÑO HOSPITAL

  PRINCIPAL INVESTIGATOR

• LUIS R. LEVEL, MD FACS

  IVSS Dr. MIGUEL PEREZ CARREÑO HOSPITAL

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pinango L, Silvia M.

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: October 1, 2011
• Last Updated: August 10, 2012
• Results First Posted: July 26, 2012

Record last verified: 2012-08