Bridged Vacuum Assisted Closure (VAC) With Compression vs. Compression Therapy in the Management of Venous Leg Ulcers: A Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to healing
研究概览
简要总结
This study randomises patients with venous leg ulcers, to be managed either using conventional compression bandages or a bridged vacuum assisted closure system under compression.
详细描述
Venous ulcers are characterised by a cyclical pattern of healing and recurrence, with recurrence rates between 45 and 70% at one year. Venous leg ulceration has been identified as a common source of morbidity and reduced quality of life, especially in the elderly population. Non-healing ulcers place the patient at a much higher risk for lower extremity amputation.
Compression therapy is currently recognised as the main treatment for venous leg ulcers. External compression is applied as a therapy for venous leg ulcers, in an attempt to reverse the increased hydrostatic pressure in the veins.
The application of negative pressure to successfully treat and aid in the healing of open wounds has been studied extensively for decades, demonstrating favourable clinical results. However, there is a lack of evidence in the literature regarding the use of VAC in venous ulcers.
The combination of negative pressure therapy and compression therapy is theorized to provide the benefits of both individual therapies. As such, the utilization of the Bridge VAC under a compression dressing is expected to expedite the healing of venous ulcers.
The investigators aim to randomise patients with venous ulcers to either be managed using conventional compression dressings or combined bridge vacuum assisted closure with compression dressings.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the obvious differences between the intervention and comparator, it is impossible to blind the participants or the care providers.
However, the investigator, the outcomes assessor and statistician are blinded to treatment received.
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
- •Aged 18 years or more
- •Provide written informed consent
- •Venous ulcer present, greater than 10cm2 in surface area
- •A C6 grading in the CEAP classification
排除标准
- •Pregnant (confirmed by β-HCG analysis). Female patients of childbearing potential are advised to adhere to an appropriate form of contraception, and those unwilling to follow contraceptive advice are excluded from the study
- •Involvement in another clinical trial in the previous six months
- •Legal incapacity
- •Patient is bed-ridden or immobile
- •Ulcer smaller than 10cm2 in surface area
- •Ischaemic ulcer/s present
- •Diabetic ulcer/s present
- •Malignant ulceration/s present
- •Ulcer exposing bone or tendon
- •Osteomyelitis
- •Pseudomonas infection
- •Presence of gangrene
- •Deep venous thrombosis (DVT) present
- •Connective tissue disease present
- •Presence of any illness that could limit long-term compliance (e.g. epilepsy)
结局指标
主要结局
Time to healing
时间窗: 12 weeks
The time taken for complete closure of the index ulcer or till the wound is judged suitable for skin grafting
次要结局
- Proportion of ulcers healed(12 weeks)
- Ulcer recurrence(12 months)