负压伤口治疗与成年冲突相关肢体伤口患者的标准治疗：一项随机对照试验的方案

Negative-Pressure Wound Therapy Versus Standard Treatment of Adult Patients With Conflict-Related Extremity Wounds: Protocol for a Randomized Controlled Trial.

作者信息

Älgå Andreas, Wong Sidney, Haweizy Rawand, Conneryd Lundgren Kalle, von Schreeb Johan, Malmstedt Jonas

机构信息

Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.

Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.

出版信息

JMIR Res Protoc. 2018 Nov 26;7(11):e12334. doi: 10.2196/12334.

DOI:10.2196/12334

PMID:30478024

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6288590/

Abstract

BACKGROUND

In armed conflict, injuries commonly affect the extremities and contamination with foreign material often increases the risk of infection. The use of negative-pressure wound therapy has been described in the treatment of acute conflict-related wounds, but reports are retrospective and with limited follow-up.

OBJECTIVE

The objective of this study is to investigate the effectiveness and safety of negative-pressure wound therapy use in the treatment of patients with conflict-related extremity wounds.

METHODS

This is a multisite, superiority, pragmatic randomized controlled trial. We are considering for inclusion patients 18 years of age and older who are presenting with a conflict-related extremity wound within 72 hours after injury. Patients are block randomly assigned to either negative-pressure wound therapy or standard treatment in a 1:1 ratio. The primary end point is wound closure by day 5. Secondary end points include length of stay, wound infection, sepsis, wound complications, death, and health-related quality of life. We will explore economic outcomes, including direct health care costs and cost effectiveness, in a substudy. Data are collected at baseline and at each dressing change, and participants are followed for up to 3 months. We will base the primary statistical analysis on intention-to-treat.

RESULTS

The trial is ongoing. Patient enrollment started in June 2015. We expect to publish findings from the trial by the end of 2019.

CONCLUSIONS

To the best of our knowledge, there has been no randomized trial of negative-pressure wound therapy in this context. We expect that our findings will increase the knowledge to establish best-treatment strategies.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02444598; http://clinicaltrials.gov/ct2/show/NCT02444598 (Archived by WebCite at http://www.webcitation.org/72hjI2XNX).

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12334.

摘要

背景

在武装冲突中，损伤通常累及四肢，而异物污染往往会增加感染风险。负压伤口疗法已被用于治疗与冲突相关的急性伤口，但相关报道多为回顾性研究，且随访有限。

目的

本研究旨在探讨负压伤口疗法用于治疗与冲突相关的四肢伤口患者的有效性和安全性。

方法

这是一项多中心、优效性、实用性随机对照试验。我们考虑纳入年龄在18岁及以上、受伤后72小时内出现与冲突相关的四肢伤口的患者。患者按1:1的比例被整群随机分配至负压伤口疗法组或标准治疗组。主要终点是伤后第5天伤口闭合情况。次要终点包括住院时间、伤口感染、脓毒症、伤口并发症、死亡以及健康相关生活质量。我们将在一项子研究中探讨经济结局，包括直接医疗费用和成本效益。在基线和每次换药时收集数据，对参与者进行长达3个月的随访。我们将基于意向性分析进行主要统计分析。