负压伤口治疗（NPWT）用于肝胰胆外科高危患者的闭合切口以预防手术部位感染：一项随机对照试验的研究方案——NP-SSI试验

Negative pressure wound therapy (NPWT) on closed incisions to prevent surgical site infection in high-risk patients in hepatopancreatobiliary surgery: study protocol for a randomized controlled trial-the NP-SSI trial.

作者信息

Brennfleck Frank W, Linsenmeier Lena, Junger Henrik H G, Schmidt Katharina M, Werner Jens M, Woehl Daniel, Zeman Florian, Mutzbauer Ingrid, Hutchinson James A, Geissler Edward K, Schlitt Hans J, Brunner Stefan M

机构信息

Department of Surgery, University Hospital Regensburg, Franz-Josef-Strauß Allee 11, 93053, Regensburg, Germany.

Center for Clinical Trials, University Hospital Regensburg, Franz-Josef-Strauß-Allee 11, 93053, Regensburg, Germany.

出版信息

Trials. 2020 Nov 9;21(1):918. doi: 10.1186/s13063-020-04831-z.

DOI:10.1186/s13063-020-04831-z

PMID:33168081

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7654160/

Abstract

BACKGROUND

Incisional surgical site infections (iSSI) in hepatopancreatobiliary (HPB) surgery usually lead to prolonged hospital stays, consume valuable resources, and impact on patients' outcome. Prophylactic closed incision negative pressure wound therapy (ciNPWT) to decrease wound complications has become available. Owing to an increasing number of studies, evidence for superiority in many indication areas has accumulated; however, in general surgery, there are a few data and those have shown contradictory results.

METHODS

In this monocentric, prospective, randomized, controlled, two-armed study, the influence of ciNPWT on incisional surgical site infection rates after HPB operations will be investigated. A total of 222 patients will be randomized 1:1 to an interventional group (7-day treatment with ciNPWT) or a control group (treated with gauze dressing). The primary parameter to evaluate efficacy is the rate of incisional SSIs within 30 days after surgery. Additionally, several clinically relevant secondary outcomes will be assessed.

DISCUSSION

A reduction in the rate of incisional SSIs would not only lead to a significant cost reduction and shorter postoperative length of stay, but may also improve postoperative quality of life for patients. While earlier publications have shown advantages for ciNPWT, recent studies did not confirm a positive effect regarding iSSI rate. Even if iSSI rate is not reduced, findings obtained from the secondary endpoints may be of clinical relevance, such as reduction of wound complication rates.

TRIAL REGISTRATION

This trial has been registered in the German Clinical Trials Register, DRKS 00015136 . Registered on 19 February 2019 and has been approved by the local ethics committee of the University of Regensburg: 18-1225-101.

摘要

背景

肝胰胆（HPB）手术中的手术切口部位感染（iSSI）通常会导致住院时间延长、消耗宝贵资源并影响患者预后。预防性闭合切口负压伤口治疗（ciNPWT）以减少伤口并发症已开始应用。由于研究数量不断增加，在许多适应症领域已积累了其优越性的证据；然而，在普通外科领域，相关数据较少且结果相互矛盾。

方法

在这项单中心、前瞻性、随机、对照、双臂研究中，将调查ciNPWT对HPB手术后手术切口部位感染率的影响。总共222名患者将按1:1随机分为干预组（接受7天ciNPWT治疗）或对照组（接受纱布敷料治疗）。评估疗效的主要参数是术后30天内手术切口SSI的发生率。此外，还将评估几个具有临床相关性的次要结局。