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负压伤口治疗减少结直肠切除术后医院感染事件的应用(NEPTUNE):一项随机对照试验。

Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections (NEPTUNE): A Randomized Controlled Trial.

机构信息

Division of General Surgery, Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.

出版信息

Ann Surg. 2019 Jul;270(1):38-42. doi: 10.1097/SLA.0000000000003111.

Abstract

OBJECTIVE

Determine if negative pressure wound therapy (NPWT) reduces surgical site infection (SSI) in primarily closed incision after open and laparoscopic-converted colorectal surgery.

BACKGROUND

SSIs after colorectal surgery are a common cause of morbidity. The prophylactic effect of NPWT has not been established. We undertook this study to evaluate if, among patients undergoing open colorectal resection, NPWT, as compared with standard postoperative dressings, is associated with a reduction in the rate of postoperative SSI.

METHODS

In a randomized, controlled trial, 300 patients undergoing elective open colorectal surgery were assigned to receive prophylactic NPWT or standard gauze dressing. The primary end-point was 30-day SSI, as assessed by wound care experts blinded to treatment arm. Secondary outcomes included length of stay. Statistical analysis was performed on an intention-to-treat basis. A priori subgroup analysis was planned for patients who received a stoma at the time of initial operation.

RESULTS

The incidence of SSI at 30-days postoperatively was no different between experimental and control groups (32% vs 34% respectively, P = 0.68). Length of stay was also no different at a median of 7 days (IQR 5) for both groups. Among patients receiving a stoma, there was also no difference in SSI between the experimental and control groups (38% vs 33% respectively, P = 0.66).

CONCLUSIONS

Prophylactic use of NPWT on primarily closed incisions after open colorectal surgery was not associated with a decrease in SSI rate when compared with standard gauze dressing.

TRIAL REGISTRATION NUMBER

Clinicaltrials.gov (NCT02007018).

摘要

目的

确定负压伤口疗法(NPWT)是否降低开放式和腹腔镜转化结直肠手术后原发性闭合切口的手术部位感染(SSI)。

背景

结直肠手术后的 SSI 是发病率的常见原因。NPWT 的预防作用尚未确定。我们进行这项研究是为了评估在接受开放式结直肠切除术的患者中,与标准术后敷料相比,NPWT 是否与降低术后 SSI 发生率相关。

方法

在一项随机对照试验中,300 名接受择期开放式结直肠手术的患者被分配接受预防性 NPWT 或标准纱布敷料。主要终点是由对治疗臂不知情的伤口护理专家评估的 30 天 SSI。次要结局包括住院时间。基于意向治疗进行统计分析。计划对初始手术时接受造口的患者进行预先亚组分析。

结果

术后 30 天 SSI 的发生率在实验组和对照组之间没有差异(分别为 32%和 34%,P=0.68)。两组的中位住院时间也没有差异,均为 7 天(IQR5)。在接受造口的患者中,实验组和对照组之间 SSI 发生率也没有差异(分别为 38%和 33%,P=0.66)。

结论

与标准纱布敷料相比,在开放式结直肠手术后原发性闭合切口预防性使用 NPWT 与 SSI 发生率降低无关。

试验注册

Clinicaltrials.gov(NCT02007018)。

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