SURGICAL SITE INFECTIONPhase 2/3NCT01203046
Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days
A Phase 2/3 study testing Ertapenem in people with SURGICAL SITE INFECTION, run by Silvia M. Pinango L..
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- SURGICAL SITE INFECTION
- What is being tested?
- Ertapenem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Oct 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: SP1 - Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days
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.
Read more
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.
Read the 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).
- Conditions
- SURGICAL SITE INFECTION
- Being tested
- Ertapenem
- Keywords
- DURATION OF THERAPY, PENETRATING ABDOMINAL TRAUMA
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtapenemDrug
Also called Invanz, Early antibiotic therapy
Ertapenem 1 gr endovenous 3 or 7 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ertapenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Other Complications
Patients with complications different to surgical site infection.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for SURGICAL SITE INFECTIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silvia M. Pinango L.
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Silvia M. Pinango L., Pinango, Silvia M. L., M.D.
- Investigators
- SILVIA M. PIÑANGO, MD, Principal investigator, IVSS Dr. MIGUEL PEREZ CARREÑO HOSPITALLUIS R. LEVEL, MD FACS, Study chair, IVSS Dr. MIGUEL PEREZ CARREÑO HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203046
- Sponsor's protocol ID
- SP 01
- Status last verified
- Aug 2012
- First submitted
- 14 Sep 2010
- Last updated
- 10 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 1754794Kirton 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.
PubMed 11086771Bozorgzadeh 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.
PubMed 10204554Schnuriger 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.
PubMed 20499202de 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.
PubMed 10678785Borbone 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.
PubMed 17045463Girgin 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.
PubMed 19562544Salim 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.
PubMed 18196326Morales 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.
PubMed 15611450Oreskovich 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.
PubMed 7055433Farre 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.
PubMed 9830844Scheunemann 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.
PubMed 21892564Pull 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.
PubMed 19914877Cheadle WG. Risk factors for surgical site infection. Surg Infect (Larchmt). 2006;7 Suppl 1:S7-11. doi: 10.1089/sur.2006.7.s1-7.
PubMed 16834549
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SP1 - Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days
- ClinicalTrials.gov ID
- NCT01203046
- Acronym / sponsor ID
- SP 01
- Conditions
- SURGICAL SITE INFECTION
- Keywords
- DURATION OF THERAPY, PENETRATING ABDOMINAL TRAUMA
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Silvia M. Pinango L.
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Dec 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Posted 26 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A: 7 DAYS ANTIBIOTIC THERAPY | Active comparator | Drug: ErtapenemErtapenem will be administrated within the first 2 hours of Hospital´s admission and the during the next 7 days after surgery. |
| GROUP B - 3 DAYS ANTIBIOTIC THERAPY | Experimental | Drug: ErtapenemErtapenem will be administrated within the first 2 hours of Hospital´s admission and during the next 3 days after surgery. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErtapenemAlso: Invanz, Early antibiotic therapyErtapenem 1 gr endovenous 3 or 7 days | Drug | GROUP A: 7 DAYS ANTIBIOTIC THERAPY, GROUP B - 3 DAYS ANTIBIOTIC THERAPY |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1754794Dellinger 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.
- Background: PubMed 11086771Kirton 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.
- Background: PubMed 10204554Bozorgzadeh 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.
- Background: PubMed 20499202Schnuriger 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.
- Background: PubMed 10678785de 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.
- Background: PubMed 17045463Borbone 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.
- Background: PubMed 19562544Girgin 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.
- Background: PubMed 18196326Salim 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.
- Background: PubMed 15611450Morales 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.
- Background: PubMed 7055433Oreskovich 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.
- Background: PubMed 9830844Farre 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.
- Background: PubMed 21892564Scheunemann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SILVIA M. PIÑANGO, MD principal investigator
IVSS Dr. MIGUEL PEREZ CARREÑO HOSPITAL
LUIS R. LEVEL, MD FACS study chair
IVSS Dr. MIGUEL PEREZ CARREÑO HOSPITAL
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ertapenem in people with SURGICAL SITE INFECTION, run by Silvia M. Pinango L..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01203046, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2012.