Department of Plastic Surgery, Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust, Aylesbury, UK.
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.
Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013555. doi: 10.1002/14651858.CD013555.pub2.
Open fractures of the major long bones are complex limb-threatening injuries that are predisposed to deep infection. Treatment includes antibiotics and surgery to debride the wound, stabilise the fracture and reconstruct any soft tissue defect to enable infection-free bone repair. There is a need to assess the effect of timing and duration of antibiotic administration and timing and staging of surgical interventions to optimise outcomes.
To assess the effects (risks and benefits) of the timing of antibiotic administration, wound debridement and the stages of surgical interventions in managing people with open long bone fractures of the upper and lower limbs.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and clinical trial registers in February 2021. We also searched conference proceedings and reference lists of included studies.
We included randomised controlled trials (RCTs) or quasi-RCTs that recruited adults with open fractures of the major long bones, comparing: 1) timings of prophylactic antibiotic treatment, 2) duration of prophylactic antibiotic treatment, 3) timing of wound debridement following injury or 4) timing of the stages of reconstructive surgery.
We used standard methodological procedures expected by Cochrane. We aimed to collect data for the following outcomes: limb function, health-related quality of life (HRQoL), deep surgical site infection, delayed or non-union, adverse events (in the short- and long-term course of recovery), and resource-related outcomes.
We included three RCTs of 613 randomised participants with 617 open fractures. Studies were conducted in medical and trauma centres in the USA and Kenya. Where reported, there was a higher proportion of men and a mean age of participants between 30 and 34 years old. Fractures were in the upper and lower limbs in one study, and were tibia fractures in two studies; where reported, these were the result of high-energy trauma such as road traffic accidents. No studies compared the timing of antibiotic treatment or wound debridement. Duration of prophylactic antibiotic treatment (1 study, 77 participants available for analysis) One study compared antibiotic treatment for 24 hours with antibiotic treatment for five days. We are very uncertain about the effects of different durations of antibiotic treatment on superficial infections (risk ratio (RR) 1.19, 95% CI 0.49 to 2.87, favours 5 day treatment; 1 study, 77 participants); this was very low-certainty evidence derived from one small study with unclear and high risks of bias, and with an imprecise effect estimate. This study reported no other review outcomes. Reconstructive surgery: timing of the stages of surgery (2 studies, 458 participants available for analysis) Two studies compared the timing of wound closure, which was completed immediately or delayed. In one study, the mean time of delay was 5.9 days; in the other study, the time of delay was not reported. We are very uncertain about the effects of different timings of wound closure on deep infections (RR 0.82, 95% CI 0.37 to 1.80, favours immediate closure; 2 studies, 458 participants), delayed union or non-union (RR 1.13, 95% CI 0.83 to 1.55, favours delayed closure; 1 study, 387 participants), or superficial infections (RR 6.45, 95% CI 0.35 to 120.43, favours delayed closure; 1 study, 71 participants); this was very low-certainty evidence. We downgraded the certainty of the evidence for very serious risks of bias because both studies had unclear and high risks of bias. We also downgraded for serious imprecision because effect estimates were imprecise, including the possibility of benefits as well as harms, and very serious imprecision when the data were derived from single small study. These studies reported no other review outcomes.
AUTHORS' CONCLUSIONS: We could not determine the risks and benefits of different treatment protocols for open long bone fractures because the evidence was very uncertain for the two comparisons and we did not find any studies addressing the other possible comparisons. Well-designed randomised trials with adequate power are needed to guide surgical and antibiotic treatment of open fractures, particularly with regard to timing and duration of antibiotic administration and timing and staging of surgery.
主要长骨的开放性骨折是复杂的肢体威胁性损伤,容易发生深部感染。治疗包括抗生素和手术清创、稳定骨折和重建任何软组织缺陷,以实现无感染的骨修复。需要评估抗生素给药的时间和持续时间以及手术干预的时间和阶段,以优化结果。
评估管理上下肢长骨开放性骨折患者时,抗生素给药时间、伤口清创和手术干预阶段的效果(风险和益处)。
我们于 2021 年 2 月检索了 Cochrane 对照试验中心注册库(CENTRAL)、MEDLINE、Embase 和临床试验注册库,并检索了会议论文集和纳入研究的参考文献列表。
我们纳入了招募主要长骨开放性骨折成年患者的随机对照试验(RCT)或准 RCT,比较了:1)预防性抗生素治疗的时间,2)预防性抗生素治疗的持续时间,3)受伤后伤口清创的时间,或 4)重建手术的阶段。
我们使用了 Cochrane 预期的标准方法学程序。我们旨在收集以下结局的数据:肢体功能、健康相关生活质量(HRQoL)、深部手术部位感染、延迟或不愈合、不良事件(在恢复的短期和长期过程中)和资源相关结局。
我们纳入了三项 RCT,涉及 613 名随机参与者的 617 例开放性骨折。这些研究在美国和肯尼亚的医疗和创伤中心进行。报告中,男性比例较高,参与者的平均年龄在 30 至 34 岁之间。骨折发生在上肢和下肢,两项研究中发生在胫骨骨折;报告中,这些骨折是由道路交通等高能创伤引起的。没有研究比较抗生素治疗或伤口清创的时间。预防性抗生素治疗的持续时间(1 项研究,77 名可分析的参与者)一项研究比较了 24 小时和 5 天的抗生素治疗。我们非常不确定不同抗生素治疗持续时间对浅表感染的影响(风险比(RR)1.19,95%置信区间 0.49 至 2.87,有利于 5 天治疗;1 项研究,77 名参与者);这是来自一项小型研究的非常低确定性证据,该研究存在不明确和高偏倚风险,并且效应估计不精确。本研究未报告其他研究结果。重建手术:手术阶段的时间(2 项研究,458 名可分析的参与者)两项研究比较了伤口闭合的时间,即立即或延迟闭合。在一项研究中,延迟时间的平均值为 5.9 天;在另一项研究中,未报告延迟时间。我们非常不确定不同伤口闭合时间对深部感染(RR 0.82,95%置信区间 0.37 至 1.80,有利于立即闭合;2 项研究,458 名参与者)、延迟愈合或不愈合(RR 1.13,95%置信区间 0.83 至 1.55,有利于延迟闭合;1 项研究,387 名参与者)或浅表感染(RR 6.45,95%置信区间 0.35 至 120.43,有利于延迟闭合;1 项研究,71 名参与者)的影响;这是非常低确定性的证据。我们因严重偏倚风险而降低了证据的确定性,因为这两项研究都存在不明确和高偏倚风险。我们还因严重不精确而降低了证据的确定性,因为效应估计不精确,包括可能有益和有害的情况,并且当数据来自单一小型研究时,存在非常严重的不精确性。这些研究未报告其他研究结果。
我们无法确定开放性长骨骨折不同治疗方案的风险和益处,因为这两个比较的证据非常不确定,我们没有发现任何研究涉及其他可能的比较。需要设计良好、具有足够效力的随机试验来指导开放性骨折的手术和抗生素治疗,特别是关于抗生素给药的时间和持续时间以及手术的时间和阶段。