State-of-the Art Treatment of Chronic Leg Ulcers: a Randomised Controlled Trial Comparing Vacuum Assisted Closure (V.A.C.®) With Modern Wound Dressings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time-to-complete-healing: i.e. the period between initial preparation of the wound and 100% epithelialisation with the primary endpoint being time-to-complete-healing.
研究概览
简要总结
Current treatment modalities for chronic leg ulcers are time consuming, expensive, and only moderately successful. Recent data suggest that creating a sub-atmospheric pressure by Vacuum Assisted Closure (V.A.C.®) therapy supports the wound healing process. Here, we studied the efficacy of V.A.C.® in the treatment of chronic leg ulcers prospectively.
详细描述
PROTOCOL
I. INTRODUCTION:
In the last 25 years we have entered an area where patients are living longer with more complex systemic pathology. The number of patients with chronic non-healing wounds continues to increase, despite many recent advances in the basic science of wound healing.
Although, the chronic leg ulcers approximately affect 1 % of the adult population of developed countries and chronic wound care consumes 1-2% of the health care budgets of European countries. It is still probably true to say that leg ulcer disease is not sufficiently recognised as a problem either by the population at large or by the medical community. Recent socio-economic and quality of life data showed the importance of this long-neglected health care problem.
In recent years, many new wound care products were developed. We have learned that a moist wound bed, without maceration of wound borders, gives faster wound healing. So, wound care products need a high absorption capacity and at the same time, they need to create a moist wound climate. However, many of these new wound care products resulted in divergent results. Complications are described like enlargement of the wounds, maceration, infections, sepsis and loss of grafts. These results in delayed hospitalisation and increased costs.
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
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with a chronic leg ulcer (> 6 months) without healing signs and satisfies to one or more criteria:
- •Venous (venous insufficiency of the deep or superficial system without an arterial incompetence)
- •Combined venous/arterial (venous insufficiency of the deep or superficial system with an ankle/brachial index of 0·60 - 0·85)
- •Arteriolosclerotic (Martorell's ulcer) leg ulcers (diagnose made by anamnesis, clinical signs, exclusions of differential diagnosis's, venous/ arterial duplex shows no signs of obstruction or major venous insufficiency, histology)
排除标准
- •ulcer duration shorter than 6 months
- •age > 85 years
- •use of immune suppressive medication
- •known type IV allergies against ingredients of the wound care products
- •insulin-dependent diabetes mellitus type I
- •severe peripheral arterial disease (ankle/brachial index <0·60)
- •vasculitic ulcers
- •neoplastic ulcers.
结局指标
主要结局
Time-to-complete-healing: i.e. the period between initial preparation of the wound and 100% epithelialisation with the primary endpoint being time-to-complete-healing.
次要结局
- 2)percentage of leg ulcer recurrences within one year (i.e. an epithelial breakdown anywhere along or within the index ulcer region)
- 3)skin-graft survival, where applicable (i.e. percentage of successfully adhered skin grafts after 4 days of complete bed rest and compression or VAC® treatment)
- 7) the costs per ulcer.
- 1)duration of the wound-bed preparation stage
- 4) the quality of life
- 5) pain scores
- 6) the total time needed for wound care until complete wound closure