Prophylactic antibiotics for penetrating abdominal trauma

  • Review
  • Intervention

Authors


Abstract

Background

Penetrating abdominal trauma occurs when the peritoneal cavity is breached. Routine laparotomy for penetrating abdominal injuries began in the 1800s, with antibiotics first being used in World War II to combat septic complications associated with these injuries. This practice was marked with a reduction in sepsis-related mortality and morbidity. Whether prophylactic antibiotics are required in the prevention of infective complications following penetrating abdominal trauma is controversial, however, as no randomised placebo controlled trials have been published to date. 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 30% to 70% infection rate with only post-operative antibiotic administration. Current guidelines state there is sufficient class I evidence to support the use of a single pre-operative broad spectrum antibiotic dose, with aerobic and anaerobic cover, and continuation (up to 24 hours) only in the event of a hollow viscus perforation found at exploratory laparotomy.

Objectives

To assess the benefits and harms of prophylactic antibiotics administered for penetrating abdominal injuries for the reduction of the incidence of septic complications, such as septicaemia, intra-abdominal abscesses and wound infections.

Search methods

Searches were not restricted by date, language or publication status. We searched the following electronic databases: the Cochrane Injuries Group Specialised Register, CENTRAL (The Cochrane Library 2008 Issue 3), MEDLINE (Ovid), EMBASE (Ovid), ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED), ISI Web of Science: Conference Proceedings Citation Index- Science (CPCI-S), PubMed. Searches were last conducted in September 2008.

Selection criteria

All randomised controlled trials of antibiotic prophylaxis or treatment in patients with penetrating abdominal trauma versus no antibiotics or placebo.

Data collection and analysis

The authors performed the literature search independently, and screened all resulting abstracts for inclusion.

Main results

We identified no trials meeting the inclusion criteria.

Authors' conclusions

There is currently no information from randomised controlled trials to support or refute the use of antibiotics for patients with penetrating abdominal trauma.

摘要

背景

預防性抗生素用於穿透性腹部創傷

穿透性腹部創傷發生在腹腔破裂時。常規性的剖腹手術用於穿透性腹部創傷始於1800年,隨之第二次大戰第一次使用抗生素以對抗有關這些損傷之敗血症的併發症。這種做法的特點是減少敗血症相關的死亡率和發生率。然而,預防性抗生素來防止感染性併發症是有爭議的,因為迄今未有隨機的安慰劑對照試驗發表。而且也有抗生素預防法使用時機的反對意見。1972年Fullen提到術前使用抗生素者其術後感染率為7%至11%,術中抗生素的施行其感染率為33%至57%,而僅於術後施行抗生素其感染率為30%至70%。現行準則聲稱有充分的一級(class I)證據支持單一術前的廣效型抗生素劑量使用,以有氧及無氧覆蓋且持續使用(至24小時),前提是只有在剖腹探查術發現中空臟器穿孔的情形下使用。

目標

評估預防性抗生素實施於穿透性腹部損傷其效益及危險性,以減少敗血性的併發症發生率,如敗血症,腹腔膿瘡及傷口感染。

搜尋策略

檢索方式不限日期,語言或發表狀況。我們搜尋以下的電子資料庫:the Cochrane Injuries Group Specialised Register, CENTRAL (The Cochrane Library 2008 Issue 3), MEDLINE (Ovid), EMBASE (Ovid), ISI Web of Science: Science Citation Index Expanded (SCIEXPANDED), ISI Web of Science: Conference Proceedings Citation Index Science (CPCIS), PubMed。最近一次檢索是在2008年9月。

選擇標準

穿透性腹部創傷患者使用抗生素預防法或治療,對照無抗生素或安慰劑組之所有的隨機對照試驗。

資料收集與分析

作者分別獨立執行文獻檢索並檢閱所有的結果摘要以納入研究。

主要結論

我們確認無試驗符合納入標準。

作者結論

目前尚未有來自隨機對照試驗其支持或反對穿透性腹部創傷患者使用抗生素的資訊。

翻譯人

本摘要由高雄榮民總醫院金沁琳翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

預防性抗生素應使用於穿透性腹部創傷患者嗎?:在過去半個世紀抗生素已使用於遭受腹腔穿透損傷的患者,以期減少術後傷口感染的發生率,腹腔感染及死亡率。這篇回顧的目的是評估這種作法是否可以經由健全的證據獲得支持。這篇回顧沒有發現符合納入標準的隨機對照試驗。所以沒有證據明確的支持或反對這種作法。現行的準則是依據專家建議而非事實。我們建議設計一個隨機對照試驗以評估何種病患將會受益於抗生素預防法,何種病患不會。期望此研究將減少不必要的抗生素使用,因而減少抗生素的抗藥性。

Plain language summary

Should prophylactic antibiotics be used in patients with penetrating abdominal trauma?

For over half a century antibiotics have been given to patients that have suffered from a penetrating injury to the abdominal peritoneal cavity in an attempt to decrease the incidence of post-operative wound infection, intra-abdominal infection and mortality. This review was designed to assess whether or not this practice is supported by robust evidence.

No randomised controlled trials could be found that met the inclusion criteria for this review. Therefore, there is no evidence to unequivocally support or refute this practice. Current guidelines are based on expert opinion rather than fact.

We recommend that a randomised control trial be designed to assess which patients would benefit from antibiotic prophylaxis, and which patients would not. Hopefully this would result in less unnecessary antibiotic use, and thus less antibiotic resistance.

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 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

  • Prophylactic antibiotic administration at the time of presentation to the emergency department, or perioperatively.

  • 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
  • Septic complications, including intra-abdominal abscesses and wound infections.

Secondary outcomes
  • Mortality.

  • Septicaemia.

Search methods for identification of studies

Searches were not restricted by date, language or publication status.

We searched the following electronic bibliographic databases:

Cochrane Injuries Group Specialised Register (searched 3 Sept 2008),
CENTRAL (The Cochrane Library 2008 Issue 3),
MEDLINE (Ovid) (1954 to Aug (week 3) 2008),
EMBASE (Ovid) (1980 to Sept 2008),
ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED) (1970 to Sept 2008),
ISI Web of Science: Conference Proceedings Citation Index-Science (CPCI-S) (1990 to Sept 2008),
PubMed (searched 4 Sept 2008: limited to last 180 days).

We also checked the reference lists of all relevant studies and reviews.

The search strategy can be found in Appendix 1.

Data collection and analysis

Selection of studies

A total of 741 references were retrieved by the search. MAB and ANG independently screened the search results to identify relevant trials. None of the references found met the inclusion criteria. We also screened the reference lists of all relevant material. 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:

  • year and language of publication;

  • year of study;

  • inclusion and exclusion criteria;

  • sample size;

  • mechanism of injury;

  • type, dose and route of prophylactic antibiotic; and

  • 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 the Cochrane Handbook for Systematic Reviews of Interventions (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.

  • Adequate: 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.

  • Unclear: if the trial is described as randomised, but the trial report fails to describe the method of allocation concealment.

  • Inadequate: 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.

  • Adequate: if a computer-generated or random-number table was used.

  • Unclear: if the trial is described as randomised, but the trial report fails to describe the method of allocation sequence.

  • Inadequate: 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.

  • Adequate: if the trial was described as double blind, and the method of blinding was described.

  • Unclear: if the trial was described as double blind, but the method of blinding was not described.

  • Not performed: if the trial was not double blind.

Follow up

We would have judged follow up as follows.

  • Adequate: 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.

  • Unclear: if the trial report gave the impression that there had been no drop-outs or withdrawals, but this was not specifically stated.

  • Inadequate: 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 relative risk (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 not 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 561 potentially relevant references. There were no randomised controlled trials that fulfilled our inclusion criteria.

Risk of bias in included studies

We included no trials in this review.

Effects of interventions

There were no trials included 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 which answer this question.

This review has illustrated the fact that prophylactic antibiotic guidelines for penetrating abdominal trauma are based on expert opinion rather than firm evidence.

Authors' conclusions

Implications for practice

There is no evidence upon which to base the use of prophylactic antibiotics in patients with penetrating abdominal injury.

Implications for research

With the emergence of multiple-drug resistant organisms the use of antibiotics should be carefully considered. A placebo controlled, randomised, double blind study is required to illicit which patients, if any, would benefit from antibiotic prophylaxis in penetrating abdominal trauma.

Acknowledgements

To the Cochrane Injuries Group for editorial support.

Data and analyses

Download statistical data

This review has no analyses.

Appendices

Appendix 1. Search strategy

Cochrane Injuries Group Specialised Register (searched 3 Sept 2008)
(abdominal or abdomen or thorax or thoracic or splenic or spleen or stomach or gastric) and (injur* or trauma* or perforat* or penetrat* or rupture or burst* or stab* or gunshot or shot or wound*) and (Antibiotic or Prophylaxis or Gentamicin* or Cefazolin* or prophylactic* or premedication* or Cefazolin or cephazolin or cefamezine or cephamezine or ancef or cefamedin or gramaxin or kefzol or totacef or Tazobactam or piperacillin or tazocin or Gentamicin* or gentamycin* or gemyticin or gimyticin or gentacycol or gentavet or genticin or garamycin* or "co-amoxiclavulanic acid" or augmentin)

CENTRAL (The Cochrane Library 2008 Issue 3)
#1 MeSH descriptor Abdominal Injuries explode all trees
#2 MeSH descriptor Thoracic Injuries explode all trees
#3 (abdominal or abdomen or thorax or thoracic) near3 (injur* or trauma* or perforat* or penetrat*)
#4 (splenic or spleen) near3 rupture*
#5 (stomach or gastric) near3 (rupture or perforation or injur* or burst*)
#6 (stab* or gunshot or shot or penetrat* wound*) near3 (abdomen* or abdominal or stomach or splenic or spleen or thorax or thoracic)
#7 MeSH descriptor Wounds, Stab explode all trees
#8 MeSH descriptor Wounds, Gunshot explode all trees
#9 MeSH descriptor Rupture explode all trees
#10 abdomen* or abdominal or stomach or splenic or spleen or thorax or thoracic
#11 (#7 OR #8 OR #9)
#12 (#10 AND #11)
#13 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #12)
#14 MeSH descriptor Antibiotic Prophylaxis explode all trees
#15 MeSH descriptor Gentamicins explode all trees
#16 MeSH descriptor Cefazolin explode all trees
#17 (antibiotic*) near5 (prophylaxis or prophylactic* or remedication*)
#18 Cefazolin or cephazolin or cefamezine or cephamezine or ancef or cefamedin or gramaxin or kefzol or totacef or Tazobactam piperacillin or tazocin or Gentamicin* or gentamycin* or g-myticin or gmyticin or gentacycol or gentavet or genticin or garamycin* or co-amoxiclavulanic acid* or augmentin
#19 (#14 OR #15 OR #16 OR #17 OR #18)
#20 (#13 AND #19)

MEDLINE (Ovid) (1954 to Aug (week 3) 2008)
1.exp Abdominal Injuries/
2.exp Thoracic Injuries/
3.((abdominal or abdomen or thorax or thoracic) adj3 (injur* or trauma* or perforat* or penetrat*)).ab,ti.
4.((splenic or spleen) adj3 rupture*).ab,ti.
5.((stomach or gastric) adj3 (rupture or perforation or injur* or burst*)).ab,ti.
6.((stab* or gunshot or shot or penetrat* wound*) adj3 (abdomen* or abdominal or stomach or splenic or spleen or thorax or thoracic)).ab,ti.
7.exp Wounds, Stab/
8.exp Wounds, Gunshot/
9.exp Rupture/
10.7 or 8 or 9
11.(abdomen* or abdominal or stomach or splenic or spleen or thorax or thoracic).ti,ab.
12.10 and 11
13.1 or 2 or 3 or 4 or 5 or 6 or 12
14.exp Antibiotic Prophylaxis/
15.exp Gentamicins/
16.exp Cefazolin/
17.(antibiotic* adj5 (prophylaxis or prophylactic* or premedication*)).ab,ti.
18.(Cefazolin or cephazolin or cefamezine or cephamezine or ancef or cefamedin or gramaxin or kefzol or totacef or Tazobactam piperacillin or tazocin or Gentamicin* or gentamycin* or g?myticin or gmyticin or gentacycol or gentavet or genticin or garamycin* or co?amoxiclavulanic acid* or augmentin).ab,ti.
19.14 or 15 or 16 or 17 or 18
20.13 and 19
21.(randomised or randomized or randomly or random order or random sequence or random allocation or randomly allocated or at random or controlled clinical trial$).tw,hw.
22.clinical trial.pt.
23.randomized controlled trial.pt.
24.randomized controlled trial.pt.
25.controlled clinical trial.pt.
26.placebo.ab.
27.clinical trials as topic.sh.
28.trial.ti.
29.21 or 22 or 23 or 24 or 25 or 26 or 27 or 28
30.humans.sh.
31.29 and 30
32.20 and 31

EMBASE (Ovid) (1980 to 4 September 2008)
1.exp Abdominal Injury/
2.exp bite wound/ or exp gunshot injury/ or exp knife cut/ or exp missile wound/ or exp stab wound/
3.(abdomen* or abdominal or stomach or splenic or spleen or thorax or thoracic).ti,ab.
4.2 and 3
5.exp spleen rupture/ or exp aorta rupture/ or exp liver rupture/ or exp stomach rupture/ or exp thorax organ rupture/ or exp urogenital tract rupture/ or exp diaphragm injury/ or exp thorax penetrating trauma/
6.1 or 4 or 5
7.((abdominal or abdomen or thorax or thoracic) adj3 (injur* or trauma* or perforat* or penetrat*)).ab,ti.
8.((splenic or spleen) adj3 rupture*).ab,ti.
9.((stomach or gastric) adj3 (rupture or perforation or injur* or burst*)).ab,ti.
10.((stab* or gunshot or shot or penetrat* wound*) adj3 (abdomen* or abdominal or stomach or splenic or spleen or thorax or thoracic)).ab,ti.
11.6 or 7 or 8 or 9 or 10
12.exp Antibiotic Prophylaxis/
13.exp Gentamicin/
14.exp Cefazolin/
15.(antibiotic* adj5 (prophylaxis or prophylactic* or premedication*)).ab,ti.
16.(Cefazolin or cephazolin or cefamezine or cephamezine or ancef or cefamedin or gramaxin or kefzol or totacef or Tazobactam piperacillin or tazocin or Gentamicin* or gentamycin* or g?myticin or gmyticin or gentacycol or gentavet or genticin or garamycin* or co?amoxiclavulanic acid* or augmentin).ab,ti.
17.12 or 13 or 14 or 15 or 16
18.11 and 17
19.exp animal model/
20.Animal Experiment/
21.exp ANIMAL/
22.exp Experimental Animal/
23.19 or 20 or 21 or 22
24.Human/
25.23 not 24
26.(randomised or randomized or randomly or random order or random sequence or random allocation or randomly allocated or at random or controlled clinical trial* or placebo).tw,hw.
27.exp clinical trial/
28.exp Randomized Controlled Trial/
29.26 or 27 or 28
30.29 not 25
31.18 and 30

ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED) (1970 to Sept 2008),
ISI Web of Science: Conference Proceedings Citation Index-Science (CPCI-S) (1990 to Sept 2008)

1.Topic=(abdominal or abdomen or thorax or thoracic or splenic or spleen or stomach or gastric)
2.Topic=(injur* or trauma* or perforat* or penetrat* or rupture or burst* or stab* or gunshot or shot or penetrat* wound*)
3.Topic=(Antibiotic or Prophylaxis or Gentamicin* or Cefazolin* or prophylactic* or premedication* or Cefazolin or cephazolin or cefamezine or cephamezine or ancef or cefamedin or gramaxin or kefzol or totacef or Tazobactam piperacillin or tazocin or Gentamicin* or gentamycin* or gemyticin or gimyticin or gentacycol or gentavet or genticin or garamycin* or co-amoxiclavulanic acid* or augmentin)
4.Topic=(randomised or randomized or randomly or random order or random sequence or random allocation or randomly allocated or at random or placebo) OR Title=(trial or controlled)
5.1 and 2 and 3 and 4

PubMed (searched 4 Sept 2008: limited to last 180 days)
1.(abdominal OR abdomen OR thorax OR thoracic OR splenic OR spleen OR stomach OR gastric) AND (injur* OR trauma OR traumatic OR perforat* OR penetrat* OR rupture OR burst* OR stab OR stabbed OR stabbing* OR gunshot OR shot OR wound*) AND (Antibiotic OR Prophylaxis OR Gentamicin* OR Cefazolin* OR prophylactic* OR premedication* OR Cefazolin OR cephazolin OR cefamezine OR cephamezine OR ancef OR cefamedin OR gramaxin OR kefzol OR totacef OR Tazobactam OR piperacillin OR tazocin OR Gentamicin* OR gentamycin* OR gemyticin OR gimyticin OR gentacycol OR gentavet OR genticin OR garamycin* OR "co-amoxiclavulanic acid" OR augmentin)
2.randomised OR randomized OR randomly OR random order OR random sequence OR random allocation OR randomly allocated OR at random OR placebo Field: Title/Abstract
3.trial OR controlled Field: Title

History

Protocol first published: Issue 4, 2008
Review first published: Issue 4, 2009

Contributions of authors

MAB and ANG independently collected the referenced studies. MAB and ANG analysed studies for inclusion independently. MAB and ANG met to discuss the results, and any discrepancies were mediated by JAG. MAB wrote the initial manuscript, which was ratified by ANG and JAG. JAG supervised the review process.

Declarations of interest

None known.