Effect of Compressive Therapies on the Healing of Venous Ulcers in Primary Health Services: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 3
- 主要终点
- Effect of the therapies on time and on the healing characteristics of venous ulcers
研究概览
简要总结
The objective of the study is to compare the effect of two treatments on the healing of venous ulcers in follow-up people in two Primary Health Services, in a city in southern Brazil. The two treatments that will be tested are: (1) the high compression elastic bandage and (2) Unna boot. The two treatments are indicated for the treatment of people with venous insufficiency and who have an active ulcer. The treatment will last 26 weeks (6 months). Once a week, during 26 weeks, a nurse will perform the dressing and will apply the therapy high compression elastic bandage or Unna boot according to a drawing and in every two weeks an evaluator will assess the characteristics of the ulcers and the size.
详细描述
The primary objective is to compare the effect of two compressive therapies, high compression elastic bandage and Unna boot, on time and on the healing characteristics of venous ulcers in Primary Health Care and the secondary objectives are to verify the effects of the therapies in tissue integrity and at the level of pain, to identify quality of life of the participants and to evaluate the cost-effectiveness of the two therapies from the perspective of the Unified Health System. A randomized clinical trial is being carried out in two Primary Health Services in Porto Alegre city, with people with active venous ulcer. 126 venous ulcers, 63 in each group will be followed. The A group receives elastic compressive therapy (high compression elastic bandage) and the B group receives inelastic compressive therapy (Unna boot) by randomization. Once a week, during 26 weeks, a nurse applies the therapy according to the randomization group. And a blind evaluator for therapies will assess the characteristics of the ulcers and the size, on the first day and in every two weeks until 26ª week.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •people with diagnosis of chronic venous insufficiency recorded in medical records, with active venous ulcer;
- •with indication of compressive therapy, who are not using any of the therapies used in the study and who have not used them within 30 days of the initial moment of data collection;
- •18 years old or older;
- •with Ankle-Brachial Index (ABI) between 0.8 and 1.2;
- •with pulses present on palpation in lower limbs;
- •walking people;
- •with Body Mass Index (BMI) between ≥ 18.5 kg/m2 and 39.9 kg/m2 (for elderly people: ≥ 22 kg/m2 and 39.9 kg/m2);
- •with ankle circumference greater than 18cm.
排除标准
- •pregnant women;
- •people with mixed, infected or in the epithelialization phase UV (with epithelial tissue in 90% of the UV area);
- •uncontrolled diabetics (with Glycated Hemoglobin greater than 7% in the last six months);
- •people with medical diagnosis of dermatological, rheumatological and oncological diseases in the member of the active UV or immunosuppressive diseases (for influencing the healing process);
- •with allergy to any f the components of the compressive therapies used in the study;
- •people using immunosuppressants and/or corticosteroids for more than 21 days (for influencing the healing process).
结局指标
主要结局
Effect of the therapies on time and on the healing characteristics of venous ulcers
时间窗: On first day and in every two weeks, during 26 weeks.
A blind evaluator for therapies will assess the characteristics of the ulcers using a Likert scale, being 1 the worst score and 5 best score, proposed to Nursing Outcomes Classification (NOC), in the outcome Wound Healing: Secondary Intention. This outcome has indicators to assess the healing characteristics, such as granulation tissue; necrosis; epithelial tissue; exsudate; erythema; oedema; macerated skin; odor and planimetry.
次要结局
- Cost-effectiveness of the therapies(26 weeks)
- Health-related quality of life(On first day, on the 12ª week and on the 26ª week.)
- The effects of the therapies at the tissue integrity(On first day and in every two weeks, during 26 weeks.)
- The effects of the therapies at the level of pain(On first day and in every two weeks, during 26 weeks.)