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高危直接前路全髋关节置换术后切口负压治疗的随机对照试验。

Randomized Controlled Trial of Incisional Negative Pressure Following High-Risk Direct Anterior Total Hip Arthroplasty.

机构信息

Department of Orthopedic Surgery, Columbia University Irving Medical Center, New York, New York.

Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, New York.

出版信息

J Arthroplasty. 2022 Aug;37(8S):S931-S936. doi: 10.1016/j.arth.2022.03.039. Epub 2022 Mar 15.

Abstract

BACKGROUND

The direct anterior (DA) approach to total hip arthroplasty (THA) is associated with higher rates of surgical site complications (SSCs) compared to other approaches, particularly among high-risk patients. Closed incision negative pressure therapy (ciNPT) is effective in reducing SSCs and surgical site infections (SSIs) in other populations. We asked whether ciNPT could decrease SSCs in high-risk patients undergoing DA THA.

METHODS

This prospective randomized controlled trial (RCT) enrolled high-risk DA THA patients at 3 centers. Patients were offered enrollment if they had previously identified risk factors for SSC: Body mass index (BMI) >30 kg/m, diabetes, active smoking, or before hip surgery. Patients were randomized after closure to either an occlusive (control) dressing or ciNPT dressing for 7 days. All 90-day SSCs were recorded. A priori power analysis demonstrated 116 patients were required to identify a 4.5x relative reduction in SSCs. Chi-square tests were used to evaluate probability of complications.

RESULTS

One hundred and twenty two patients enrolled; 120 completed data collection. SSCs occurred in 18.3% (11/60) of control patients compared to 8.3% (5/60) of ciNPT patients (χ = 2.60, P = .107). SSCs included dehiscence to the subcutaneous level (13) and prolonged drainage (3). Nine control (15.0%) and 2 ciNPT (3.3%) patients met CDC criteria for superficial SSI (χ = 4.90, P = .027). Fifteen of 16 SSCs resolved with local wound care. One in the ciNPT group required reoperation for acute PJI.

CONCLUSION

Among patients at risk of surgical site complications undergoing DA THA, we identified a significant reduction in superficial SSIs and a trend toward lower overall SSCs with ciNPT.

摘要

背景

与其他入路相比,直接前入路(DA)全髋关节置换术(THA)与更高的手术部位并发症(SSC)发生率相关,尤其是在高危患者中。闭合切口负压治疗(ciNPT)在减少其他人群的 SSC 和手术部位感染(SSI)方面是有效的。我们想知道 ciNPT 是否可以降低接受 DA-THA 的高危患者的 SSC。

方法

这项前瞻性随机对照试验(RCT)在 3 个中心招募了高危 DA-THA 患者。如果患者有以下 SSC 的先前确定的危险因素,他们将被纳入:体重指数(BMI)>30kg/m、糖尿病、吸烟或髋关节手术前。所有 90 天的 SSCs 均被记录。预先的功效分析表明,需要 116 例患者才能确定 SSCs 相对减少 4.5 倍。卡方检验用于评估并发症的概率。

结果

共有 122 例患者入组,120 例完成了数据收集。对照组患者的 SSCs 发生率为 18.3%(11/60),ciNPT 组为 8.3%(5/60)(χ²=2.60,P=0.107)。SSC 包括切口到皮下层裂开(13 例)和引流时间延长(3 例)。9 例对照组(15.0%)和 2 例 ciNPT 组(3.3%)患者符合 CDC 浅表 SSI 标准(χ²=4.90,P=0.027)。16 例 SSC 中有 15 例经局部伤口护理治愈。ciNPT 组中有 1 例因急性 PJI 需要再次手术。

结论

在接受 DA-THA 的有 SSC 风险的患者中,我们发现 ciNPT 可显著降低浅表 SSI 的发生率,并且总体 SSC 的发生率有降低的趋势。

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