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清创至灌洗时间对开放性骨折再次手术率的影响:一项基于倾向评分的开放式伤口冲洗(FLOW)研究分析。

The effect of time to irrigation and debridement on the rate of reoperation in open fractures : a propensity score-based analysis of the Fluid Lavage of Open Wounds (FLOW) study.

机构信息

Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Ontario, Canada.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

出版信息

Bone Joint J. 2021 Jun;103-B(6):1055-1062. doi: 10.1302/0301-620X.103B6.BJJ-2020-2289.R1.

Abstract

AIMS

Despite long-standing dogma, a clear relationship between the timing of surgical irrigation and debridement (I&D) and the development of subsequent deep infection has not been established in the literature. Traditionally, I&D of an open fracture has been recommended within six hours of injury based on animal studies from the 1970s, however the clinical basis for this remains unclear. Using data from a multicentre randomized controlled trial of 2,447 open fracture patients, the primary objective of this secondary analysis is to determine if a relationship exists between timing of wound I&D (within six hours of injury vs beyond six hours) and subsequent reoperation rate for infection or healing complications within one year for patients with open limb fractures requiring surgical treatment.

METHODS

To adjust for the influence of patient and injury characteristics on the timing of I&D, a propensity score was developed from the dataset. Propensity-adjusted regression allowed for a matched cohort analysis within the study population to determine if early irrigation put patients independently at risk for reoperation, while controlling for confounding factors. Results were reported as odds ratios (ORs), 95% confidence intervals (CIs), and p-values. All analyses were conducted using STATA 14.

RESULTS

In total, 2,286 of 2,447 patients randomized to the trial from 41 orthopaedic trauma centres across five countries had complete data regarding time to I&D. Prior to matching, the patients managed with early I&D had a higher proportion requiring reoperation for infection or healing complications (17% vs 13%; p = 0.019), however this does not account for selection bias of more severe injuries preferentially being treated earlier. When accounting for propensity matching, early irrigation was not associated with reoperation (OR 0.71 (95% CI 0.47 to 1.07); p = 0.73).

CONCLUSION

When accounting for other variables, late irrigation does not independently increase risk of reoperation. Cite this article:  2021;103-B(6):1055-1062.

摘要

目的

尽管长期以来一直存在着一种教条,即手术冲洗和清创(I&D)的时间与随后发生深部感染之间存在明确的关系,但在文献中尚未得到证实。传统上,根据 20 世纪 70 年代的动物研究,建议在受伤后 6 小时内对开放性骨折进行 I&D,然而,其临床依据尚不清楚。本二次分析使用来自一项多中心、随机对照试验的 2447 例开放性骨折患者的数据,主要目的是确定伤口 I&D 的时间(受伤后 6 小时内与超过 6 小时)与需要手术治疗的肢体开放性骨折患者一年内感染或愈合并发症的再次手术率之间是否存在关系。

方法

为了调整患者和损伤特征对 I&D 时间的影响,从数据集开发了倾向评分。倾向评分调整后的回归允许在研究人群中进行匹配队列分析,以确定早期冲洗是否使患者独立面临再次手术的风险,同时控制混杂因素。结果以比值比(ORs)、95%置信区间(CIs)和 p 值报告。所有分析均使用 STATA 14 进行。

结果

在总共 2447 例随机分配到试验的患者中,有 2286 例来自五个国家的 41 个骨科创伤中心,有完整的关于 I&D 时间的数据。在匹配之前,早期 I&D 治疗的患者中,需要再次手术治疗感染或愈合并发症的比例更高(17%比 13%;p = 0.019),但这并不能说明更严重的损伤更倾向于更早治疗而导致的选择偏倚。当考虑到倾向匹配时,早期冲洗与再次手术无关(OR 0.71(95% CI 0.47 至 1.07);p = 0.73)。

结论

当考虑到其他变量时,晚期冲洗不会独立增加再次手术的风险。引用本文:2021;103-B(6):1055-1062。

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