一项比较渐层式三层直筒型弹性绷带系统与标准短型弹性压迫绷带系统在治疗静脉溃疡患者之效果的初步随机对照临床试验议定书：3VSS2008。

Protocol for a pilot randomised controlled clinical trial to compare the effectiveness of a graduated three layer straight tubular bandaging system when compared to a standard short stretch compression bandaging system in the management of people with venous ulceration: 3VSS2008.

机构信息

Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Level 3 Burnet Building, The Alfred Hospital, Monash University, Melbourne, Australia.

出版信息

Trials. 2010 Mar 9;11:26. doi: 10.1186/1745-6215-11-26.

DOI:10.1186/1745-6215-11-26

PMID:20214822

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2847559/

Abstract

BACKGROUND

The incidence of venous ulceration is rising with the increasing age of the general population. Venous ulceration represents the most prevalent form of difficult to heal wounds and these problematic wounds require a significant amount of health care resources for treatment. Based on current knowledge multi-layer high compression system is described as the gold standard for treating venous ulcers. However, to date, despite our advances in venous ulcer therapy, no convincing low cost compression therapy studies have been conducted and there are no clear differences in the effectiveness of different types of high compression.

METHODS/DESIGN: The trial is designed as a pilot multicentre open label parallel group randomised trial. Male and female participants aged greater than 18 years with a venous ulcer confirmed by clinical assessment will be randomised to either the intervention compression bandage which consists of graduated lengths of 3 layers of elastic tubular compression bandage or to the short stretch inelastic compression bandage (control). The primary objective is to assess the percentage wound reduction from baseline compared to week 12 following randomisation. Randomisation will be allocated via a web based central independent randomisation service (nQuery v7) and stratified by study centre and wound size <or= 10 cm2 or >10 cm2. Neither participants nor study staff will be blinded to treatment. Outcome assessments will be undertaken by an assessor who is blinded to the randomisation process.

DISCUSSION

The aim of this study is to evaluate the efficacy and safety of two compression bandages; graduated three layer straight tubular bandaging (3L) when compared to standard short stretch (SS) compression bandaging in healing venous ulcers in patients with chronic venous ulceration. The trial investigates the differences in clinical outcomes of two currently accepted ways of treating people with venous ulcers. This study will help answer the question whether the 3L compression system or the SS compression system is associated with better outcomes.

TRIAL REGISTRATION

ACTRN12608000599370.

摘要

背景

随着人口老龄化的增加，静脉溃疡的发病率正在上升。静脉溃疡是最常见的难以愈合的伤口形式，这些有问题的伤口需要大量的医疗资源来治疗。基于目前的知识，多层高压系统被描述为治疗静脉溃疡的金标准。然而，迄今为止，尽管我们在静脉溃疡治疗方面取得了进展，但尚未进行任何令人信服的低成本压缩治疗研究，并且不同类型的高压在有效性方面也没有明显差异。

方法/设计：该试验设计为一项多中心开放标签平行组随机试验。年龄大于 18 岁的患有临床确诊静脉溃疡的男性和女性参与者将被随机分配到干预压缩绷带组，该组由 3 层弹性管状压缩绷带组成的渐缩长度组成，或短拉伸非弹性压缩绷带（对照组）。主要目的是评估随机分组后第 12 周与基线相比的伤口面积减少百分比。随机分组将通过基于网络的中央独立随机分组服务（nQuery v7）进行，并按研究中心和伤口大小<10cm2或>10cm2进行分层。参与者和研究人员都不会对治疗方法进行盲法。结局评估将由一名对随机过程不知情的评估人员进行。