Does timing to operative debridement affect infectious complications in open long-bone fractures? A systematic review

Mara L Schenker, Sarah Yannascoli, Keith D Baldwin, Jaimo Ahn, Samir Mehta
Journal of Bone and Joint Surgery. American Volume 2012 June 20, 94 (12): 1057-64

BACKGROUND: Existing guidelines recommend emergency surgical debridement of open fractures within six hours after injury. The aim of this study was to systematically review the association between time to operative debridement of open fractures and infection.

METHODS: Searches of the MEDLINE, EMBASE, and Cochrane computerized literature databases and manual searches of bibliographies were performed. Randomized controlled trials and cohort studies (retrospective and prospective) evaluating the association between time to operative debridement and infection after open fractures were included. Descriptive and quantitative data were extracted. A meta-analysis of patient cohorts who underwent early or delayed debridement was performed with use of a random effects model.

RESULTS: The initial search identified 885 references. Of the 173 articles inspected further on the basis of the title, sixteen (six prospective and ten retrospective cohort studies with a total of 3539 open fractures) were included. No significant difference in the infection rate was detected between open fractures debrided early or late according to any of the time thresholds used in the included studies. Sensitivity analyses demonstrated no difference in infection rate between early and late debridement in subgroups defined according to the Gustilo-Anderson classification, level of evidence, depth of infection, or anatomic location.

CONCLUSIONS: The data did not indicate an association between delayed debridement and higher infection rates when all infections were considered, when only deep infections were considered, or when only more severe open fracture injuries were considered. On the basis of this analysis, the historical “six-hour rule” has little support in the available literature. It is important to realize that additional carefully conducted studies are needed and that elective delay of treatment of patients with open fractures is not recommended

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Rune Jakobsen

Bogdans comments: The first thing to remember is that a systematic review (and its subsequent evaluation, the meta-analysis) is only as good as the involved trials. The ideal situation is a review of only high-quality randomized controlled trials, but generally that does not happen. Any systematic review in which most of the included studies are retrospective carries significant bias, the most important of which are selection bias (what gets chosen), publication bias (maybe the only published studies are the ones that found a positive result, and all the negative results were not published), and unavailability of data (a notorious problem in all studies, but particularly retrospective). This is part and parcel of combining different studies. The reality is that most orthopaedic trauma issues are not ethically amenable to a randomized controlled situation, because trauma is by nature unpredictable. So, we get what we get.

That said, combining many studies can give you an overall sense of the important factors that come up on a specific topic, even if you don't really know exactly how much influence those factors have. If the same thing is happening across multiple research endeavors, it is likely not by chance.

This study is practice-changing in the sense that it challenges the dogma to the "six-hour rule," which was used to make surgeons operate in the middle of the night for an open fracture that could otherwise wait until morning. Like many of our dogmas, it is unclear where this came from; the intro points to an article from the 1970s suggesting an increase in bacterial growth after 5 hours. However, the dogma has never been held to a rigorous examination, partially due to the legal issues if a patient was taken "too late" to the OR. Someone astute noticed that often, the six-hour rule was violated (for other reasons) and people still seemed to do fine. This paper evaluates 16 studies that look at this. Keep in mind, non-long bone injuries and gunshot wounds were excluded. Analysis looking specifically at 6 hours as a cutoff found no difference in deep infection rates (although criteria for deep infection varied). Even up to 12 hours didn't make a difference (odds ratio 1.04). With regard to Type III injuries or injuries specifically to the lower extremity and injuries of only the tibia (a subcutaneous bone, hence the worry), the 6 hour cutoff also did not matter. Importantly, the timing of antibiotic administration was not well-defined; and given recent work that administration of antibiotics within 1 hour of injury makes the most difference in infection rates, that is a very significant and important confounder. We also do not know what debridement quality was like among the studies.

For more on the confusing world of biostats (which you need to understand if you want to use data to guide your treatment decisions), you can check out Kocher MS, Zurakowski D. Clinical epidemiology and biostatistics: a primer for orthopaedic surgeons. JBJS Am 2004;86(3):607-20.


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