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临床试验/NCT00202267
NCT00202267已完成2 期

Community Randomised Control Trial of the Effectiveness of Two Compression Bandaging Technologies

Queen's University15 个研究点 分布在 1 个国家目标入组 426 人开始时间: 2004年1月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
426
试验地点
15
主要终点
4 weeks or greater improvement in time-to-healing with short-stretch bandages compared to the four-layer bandaging system

研究概览

简要总结

Leg ulcers are emotionally distressing and painful, and often require months or years to heal. Although rarely acknowledged as a pressing health care issue, leg ulcers comprise a common, complex, and costly condition, managed primarily through community home care services. Indeed, leg ulcers are the most frequently seen and treated chronic wound. There is consensus in recent international, evidence-based practice guidelines that graduated, multi-layer compression is the most effective treatment, and greatly reduces healing time. High compression is more effective than low compression. However, there is no clear evidence as to which high compression technology is the most effective in promoting healing, the most acceptable to patients, or the most cost-effective to the health care system. This study is designed to answer these questions through a randomized trial conducted in the community, where most leg ulcer care currently takes place. Issues such as effectiveness in healing, quality of life, physical discomfort, personal preference, cost to the system and to the individual will be taken into consideration in evaluating two most commonly used types of compression bandaging.

详细描述

Background:

Although rarely recognized as a pressing health care problem, leg ulcers comprise a common, complex, and costly condition. Over 80% of ongoing management of chronic wounds occurs in the community, and leg ulcers are one of the most frequently seen chronic wounds. The cost of leg ulcer care is considerable, being reported in both the UK and France to account for 2% of their total national health budgets. In Canada, the impact is only now being recognized due to the pressure on home care caseloads resulting from hospital downsizing, nursing shortages, and growing numbers of complex health populations. In one Ontario study, the care for fewer than 200 community leg ulcer cases cost in excess of $1.5 million for supplies and nursing visits, which translates to $100s of millions yearly Canada-wide. The impact on the individual is significant--chronic, painful, and often takes years to heal. Two-thirds of individuals with leg ulcers have at least one recurrence, and 45% have a history with the condition dating back 10 years.

State of Knowledge & Clinical Practice Guidelines:

Over the past decade, evidence from RCT studies and a recent Cochrane systematic review in BMJ demonstrated that venous leg ulcers treated with compression therapy are more likely to heal. Multi-layer high compression systems are more effective than low compression. However, the small number of people in trials comparing different high compression systems meant the review was unable to draw conclusions about their relative merit. Four of these trials have compared 4-layer bandage with short stretch technologies--the most commonly used technologies in Canada. In total, these trials involved only 220 patients, and were thus underpowered. Furthermore, they did not consider factors such as client preference and ease of use, or incorporate an economic evaluation.

Plan of Investigation:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •clinical presentation of venous insufficiency
  • •leg ulcer equal to or larger than 0.7 cm in any one dimension
  • •ulcer a minimum duration of 1 week
  • •ankle brachial pressure index equal to or greater than 0.80
  • •participant can provide written consent
  • •participant can communicate in English, or translation available
  • •participant 18 years or over

排除标准

  • •diagnosed with Diabetes Mellitus - insulin dependent or participant on oral hypoglycemics
  • •participants who failed to improve over a 3-month period after being treated with either the SS or 4-layer compression bandaging system prior to the trial
  • •previous trial patients (ie individuals previously enrolled in the study but now have recurrence or a new ulcer)
  • •symptoms of cognitive impairment noted

研究组 & 干预措施

1

Active Comparator

Clients randomized to short-stretch bandaging application

干预措施: Short-stretch Bandage (Non-elastomeric) (Device)

2

Active Comparator

Clients randomized to four-layer bandaging application

干预措施: Four-layer Bandage (Elastomeric) (Device)

结局指标

主要结局

4 weeks or greater improvement in time-to-healing with short-stretch bandages compared to the four-layer bandaging system

时间窗: Time to healing or up to 12 months; post-healing follow-up

次要结局

  • rate of reduction in ulcer area(Baseline and time of healing)
  • expenditures over a one-year follow-up(From baseline to time of healing)
  • quality of life(Baseline and every 3 months)
  • Recurrence(Status recorded at last visit of each month; one year post-healing follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Margaret Harrison

Principal Investigator

Queen's University

研究点 (15)

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