Antibióticos profilácticos para el traumatismo abdominal penetrante
Resumen
Antecedentes
El traumatismo abdominal penetrante se produce cuando se incide la cavidad peritoneal. La laparotomía habitual para las lesiones abdominales penetrantes comenzó en el siglo XIX y los antibióticos se utilizaron por primera vez en la Segunda Guerra Mundial para combatir las complicaciones sépticas asociadas con estas lesiones. Esta práctica se caracterizó por una reducción de la mortalidad y la morbilidad relacionadas con la sepsis. Sin embargo, aún es polémico si la profilaxis con antibióticos es necesaria para la prevención de las complicaciones infecciosas después de un traumatismo abdominal penetrante, ya que hasta la fecha no se han publicado ensayos aleatorios controlados con placebo. También ha habido debate acerca del momento adecuado para la profilaxis con antibióticos. En 1972 Fullen observó una tasa de infección posquirúrgica del 7% al 11% con el uso de antibióticos preoperatorios, una tasa de infección del 33% al 57% con la administración de antibióticos intraoperatorios y una tasa de infección del 30% al 70% con la administración de antibióticos posoperatorios solamente. Las guías actuales señalan que hay suficientes pruebas de clase I para apoyar el uso de una dosis única de antibióticos de amplio espectro en el preoperatorio que cubra los microorganismos aerobios y anaerobios, y que se continúe (hasta 24 horas) sólo en caso de que se encuentre una perforación de vísceras huecas en la laparotomía exploradora.
Objetivos
Evaluar los beneficios y los daños de los antibióticos profilácticos administrados para las lesiones abdominales penetrantes para la reducción de la incidencia de complicaciones sépticas como la sepsis, los abscesos intraabdominales y las infecciones de la herida.
Métodos de búsqueda
No hubo restricciones de fecha, idioma o estado de publicación en las búsquedas. Se hicieron búsquedas en las siguientes bases de datos electrónicas: registro especializado del Grupo Cochrane de Lesiones (Cochrane Injuries Group), CENTRAL (The Cochrane Library 2019, número 7 de 12), MEDLINE (OvidSP), Embase (OvidSP), ISI Web of Science: Science Citation Index Expanded (SCI‐EXPANDED), ISI Web of Science: Conference Proceedings Citation Index‐ Science (CPCI‐S) y PubMed. Las búsquedas se realizaron por última vez el 23 de julio de 2019.
Criterios de selección
Todos los ensayos controlados aleatorios de profilaxis antibiótica en pacientes con traumatismo abdominal penetrante versus ningún antibiótico o placebo.
Obtención y análisis de los datos
Dos autores de forma independiente revisaron los resultados de la búsqueda en la literatura.
Resultados principales
No se identificaron ensayos que cumplieran los criterios de inclusión.
Conclusiones de los autores
En la actualidad no se cuenta con información derivada de ensayos controlados aleatorios que apoyen el uso de antibióticos para pacientes con traumatismos abdominales penetrantes.
PICOs
Resumen en términos sencillos
¿Los antibióticos profilácticos se deben utilizar en los pacientes con traumatismo abdominal penetrante?
Durante más de medio siglo se les han administrado antibióticos a los pacientes que presentan una lesión penetrante en la cavidad peritoneal abdominal, en un intento por reducir la incidencia de la infección de la herida posoperatoria, la infección intraabdominal y la mortalidad. Esta revisión se diseñó para evaluar si esta práctica está apoyada o no por pruebas médicas.
No se pudo encontrar ningún ensayo controlado aleatorio que cumpliera con los criterios de inclusión para esta revisión. Por lo tanto, no existen pruebas para apoyar o refutar de forma fiable esta práctica. Las guías actuales se basan en la opinión de expertos, en lugar de en hechos.
Se recomienda que se diseñe un ensayo controlado aleatorio para evaluar qué pacientes se beneficiarían con la profilaxis con antibióticos y qué pacientes no. Se espera que lo anterior dé lugar a una disminución del uso innecesario de antibióticos y por lo tanto a menos resistencia a los antibióticos.
Authors' conclusions
Background
Penetrating abdominal trauma occurs when the peritoneal cavity is breached. Routine laparotomy for penetrating abdominal injuries began in the 1800s, but the discovery of penicillin in 1928 by Alexander Fleming allowed antibiotics to be used in the second World War to combat septic complications (Poole 1944). This practice was marked by a reduction in sepsis related mortality and morbidity. This was later ratified during the Korean war when casualties were given prophylactic antibiotics while awaiting transfer to hospital for further management (Scott 1954). Whether prophylactic antibiotics are required in the prevention of infective complications following penetrating abdominal trauma today is controversial as no randomised, placebo controlled trials have been published to date. Now, with the use of new sterilisation techniques for both surgical instruments and the surgical field, and a change in thinking with regard to hollow viscus perforation management, there may be a shift in the need for antibiotic usage in penetrating abdominal trauma.
There has also been debate about the timing of antibiotic prophylaxis. In 1972 Fullen noted a 7% to 11% post‐surgical infection rate with pre‐operative antibiotics, a 33% to 57% infection rate with intra‐operative antibiotic administration and a 30% to 70% infection rate with only post‐operative antibiotic administration (Fullen 1972). According to current guidelines there is sufficient class I evidence to support the use of a single pre‐operative broad spectrum antibiotic dose with aerobic and anaerobic cover (Thadepalli 1972; Thadepalli 1973), with continuation (up to 24 hours) only in the event of a hollow viscus perforation found at exploratory laparotomy (Luchette 2000).
The aim of this review was to assess the benefits or harms of prophylactic antibiotics administered for penetrating abdominal injuries in terms of reducing the incidence of septic complications, such as septicaemia, intra‐abdominal abscesses and wound infections.
Objectives
To assess whether there was a reduction in the incidence of infective complications following the administration of prophylactic antibiotics in penetrating abdominal trauma (wounds that enter the peritoneal cavity).
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials.
Types of participants
Patients who had an isolated penetrating abdominal wound, were not on antibiotics, and had no evidence of intra‐abdominal sepsis or any other focus of infection.
Types of interventions
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Prophylactic antibiotic administration at the time of presentation to the emergency department, or perioperatively.
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Placebo or no antibiotic.
Trials would have been included regardless of the type, dose or route of administration of the antibiotic(s).
Types of outcome measures
Primary outcomes
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Septic complications, including intra‐abdominal abscesses and wound infections.
Secondary outcomes
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Mortality.
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Septicaemia.
Search methods for identification of studies
Searches were not restricted by date, language or publication status.
Electronic searches
The Cochrane Injuries Group Information Specialist searched the following databases:
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Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 7) in the Cochrane Library (searched 23 July 2019);
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MEDLINE Ovid and Epub Ahead of Print, In‐Process & Other Non‐Indexed Citations and Daily (1946 to 23 July 2019);
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Embase Classic + Embase Ovid (1947 to 23 July 2019);
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Clarivate Analytics Web of Science databases:
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Science Citation Index Expanded (1970 to 23 July 2019);
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Conference Proceedings Citation Index ‐ Science (1990 to 23 July 2019);
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Emerging Sources Citation Index (2015 to 23 July 2019).
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The search strategy for the 2019 search can be found in Appendix 1, and the original search strategy used for the review versions published in 2009 and 2013 can be found in Appendix 2.
Searching other resources
We screened the reference lists of published articles for potential studies. We also searched the following clinical trials registries:
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ClinicalTrials.gov (http://www.clinicaltrials.gov/; searched 23 July 2019);
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Current Controlled Trials (http://www.controlled‐trials.com/; searched 23 July 2019).
Data collection and analysis
Selection of studies
A total of 8610 references were retrieved by the search. For the 2019 update, two authors of Herrod 2019 independently screened the updated search. For the previous 2013 version of this review, MAB and ANG independently screened the search results to identify relevant trials.
None of the study reports found met the inclusion criteria. No trials were identified for inclusion in the review.
Data extraction and management
Had suitable studies been found, MAB and ANG would have independently extracted the following data from identified trials:
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year and language of publication;
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year of study;
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inclusion and exclusion criteria;
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sample size;
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mechanism of injury;
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type, dose and route of prophylactic antibiotic; and
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incidence of complications.
Assessment of risk of bias in included studies
MAB and ANG would have assessed the risk of bias of each trial independently. MAB and ANG would have recorded whether or not the trial authors performed their analysis using an intention‐to‐treat method. We would have clarified any unclear or missing information through contact with the trial report authors. We would have resolved differences in opinion between the review authors during extraction of data through discussion. JAG was to have served as arbitrator, should differences in opinion have persisted.
MAB and ANG would have assessed the risk of bias of the trials independently, without masking trial names. The review authors would have followed the instructions given in chapter 8 of the Cochrane Handbook (Handbook 2008). Due to the risk of biased overestimation of intervention effects in randomised trials that are of inadequate methodological quality (Kjaergard 2001; Moher 1998; Schulz 1995), the review authors would have looked at the influence of the methodological quality of the trials on the results by evaluating the reported randomisation and follow‐up procedures in each trial. Where information was not available in the published trial reports, MAB and ANG would have contacted the authors in order to assess the trials correctly.
The review authors would have assessed generation of allocation sequence, allocation concealment, blinding and follow up. We would have presented this information in the 'Risk of bias' table in the review.
Allocation concealment
We would have judged allocation concealment as follows.
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Low risk of bias: if performed by means of centralised or pre‐numbered containers administered serially to patients, or an on‐site computer with allocations in a locked unreadable file, or sequentially‐numbered, sealed, opaque envelopes.
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Unclear: if the trial is described as randomised, but the trial report fails to describe the method of allocation concealment.
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High risk of bias: if a completely transparent procedure was used, e.g. case record numbers, dates of birth, or an open list of random numbers.
Allocation sequence generation
We would have judged allocation sequence generation as follows.
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Low risk of bias: if a computer‐generated or random‐number table was used.
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Unclear: if the trial is described as randomised, but the trial report fails to describe the method of allocation sequence.
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High risk of bias: if patients were allocated according to names, dates, admittance numbers, etc. Trials using these methods are known as quasi‐randomised trials, and would have been excluded from the review.
Blinding
We would have judged blinding as follows.
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Low risk of bias: if the trial was described as double blind, and the method of blinding was described.
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Unclear: if the trial was described as double blind, but the method of blinding was not described.
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High risk of bias: if the trial was not double blind.
Follow up
We would have judged follow up as follows.
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Low risk of bias: if the numbers and reasons for drop‐outs and withdrawals in all intervention groups were described, or if it was specified that there were no drop‐outs or withdrawals.
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Unclear: if the trial report gave the impression that there had been no drop‐outs or withdrawals, but this was not specifically stated.
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High risk of bias: if the numbers or reasons for drop‐outs and withdrawals were not described.
MAB and ANG would have recorded sample sizes and durations of follow up.
The authors would have used a funnel plot to explore bias (Macaskill 2001). We would have performed the linear regression approach described by Egger et al to determine funnel plot asymmetry (Egger 1997).
Measures of treatment effect
We would have analysed dichotomous data for risk ratio (RR) and odds ratio (OR), and measured the absolute effects with risk differences (RD). We would have calculated confidence intervals (CIs) at 95% for these measures of effect. We would also have considered treatment effect by intention‐to‐treat analysis, using available case analysis and analysis by imputation. We would have used the Mantel‐Haenszel method for the meta‐analysis (Greenland 1985; Mantel 1959). We would have presented results as a forest plot. We would have used the Cochrane Collaboration's Review Manager software for data analysis (Review Manager 2008).
Subgroup analysis and investigation of heterogeneity
We would have tested statistical heterogeneity using the I2 test (Higgins 2002) and the Chi2 test, with a P value of 0.10 representing statistical significance. If heterogeneity was identified, we would have considered performing subgroup analyses. Subgroups that would then have been considered include: injury severity scores, time to surgical intervention, organs injured, different antibiotics and trials with a low risk of bias (adequate generation of allocation sequence, allocation concealment, blinding and follow up) compared to trials with a high risk of bias (one or more of the four components of methodological quality judged as being inadequate or unclear). If the results in the fixed‐effect and random‐effects models did not differ, we would have reported the fixed‐effect model. Otherwise, we would have reported the results of both models.
Results
Description of studies
The search resulted in 8610 potentially relevant references. There were no randomised controlled trials that fulfilled our inclusion criteria. The study selection process is summarized in the PRISMA flow diagram (Figure 1).
Study flow diagram.
Risk of bias in included studies
We could not identify any trials to include in this review.
Effects of interventions
We could not identify any trials to include in this review.
Discussion
Since the discovery of penicillin in 1928 there has been a marked reduction in post‐operative septic complications. This is especially true during war situations with prolonged extraction times, and delay to surgical intervention (Scott 1954). Antibiotics were introduced in the trauma setting almost 100 years ago (Poole 1944) with little thought as to their appropriate use. Improved surgical technique and equipment, together with surgical site preparation, post‐operative care and the concept of expedient management has resulted in further improvement in mortality and morbidity figures.
We asked the question of whether or not we should be using prophylactic antibiotics with penetrating abdominal trauma. However we were not able to include any studies in this review, and thus cannot draw any conclusions about whether prophylactic antibiotics have an effect on septic complications, mortality or septicaemia compared to no antibiotic or a placebo.
This review has illustrated the fact that prophylactic antibiotic guidelines for penetrating abdominal trauma are based on expert opinion rather than firm evidence.
As prophylactic antibiotics are recommended by current guidance, another review has examined the evidence from head‐to‐head trials of different prophylactic antibiotics and duration of use for penetrating abdominal trauma (Herrod 2019).
