Effectiveness of a Hydrophobic Dressing for Microorganisms' Colonization and Infection Control of Vascular Ulcers: An Open, Controlled, Randomized Study, With Blinded Endpoint (PROBE Trial): CUCO-UV Study
试验速览
- 阶段
- 4 期
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Microorganisms' Colonization Level
研究概览
简要总结
This study will determine the effectiveness of CUTIMED® hydrophobic dressings against AQUACEL® silver dressings in bacterial colonization of vascular ulcers.
详细描述
Chronic wounds with torpid evolution are a real challenge for health services today. In the case of venous ulcers, it is estimated that more than 80% of these wounds may be colonized or infected by bacteria, which is associated with its chronification by delaying the healing process.
The most widespread therapeutic strategy in routine clinical practice is the use of silver dressings, due to its high antimicrobial power, although the effectiveness of these in venous ulcers is not supported by solid evidence. In addition, there are some uncertainties about the possible adverse effects of systemic absorption of silver molecules, as well as bacterial resistance to silver and the high cost associated with prolonged treatments.
In this sense, a novel method to deal with this problem is the use of dressings with high hydrophobic power, such as CUTIMED®.
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
- 否
入选标准
- •Adult patients with chronic venous vascular ulcer located in lower limbs with signs of critical colonization, according to the criteria of Lazareth and Moore, which imply the presence of at least 3 of the following five:
- •Severe pain during dressing change
- •Perilesional edema.
- •Local edema.
- •Unpleasant smell.
- •Abundant pus
- •Microbial colonization higher than 100000 CFUs
排除标准
- •Patients younger than 18 years old.
- •Venous ulcer with signs of infection which requires antibiotic therapy
- •Venous ulcers that do not meet Lazareth and Moore criteria
- •Arterial ulcers.
- •Patients with type I or type II diabetes.
- •Patients with immunosuppression of any etiology or in immunosuppressive treatment or with NSAIDs.
- •Patients with rheumatoid arthritis in the acute phase.
- •Patients with dermatitis prior to the appearance of the ulcer.
- •Patients with neuropathy or lack of sensitivity of any etiology.
- •Patients who, for local or systemic clinical reasons, will need to initiate antibiotic therapy.
结局指标
主要结局
Microorganisms' Colonization Level
时间窗: Change from baseline, at 4, 8 and 12 weeks
Evaluated by Reverse Transcription Polymerase Chain Reaction (RT-PCR) identification technique and quantified in colony forming units (CFU) and in ng of bacterial DNA per μL of vascular ulcer exudate.
次要结局
- Pain due to the wound(Change from baseline at 4, 8 and 12 weeks)
- Healing time(Change from baseline at 4, 8 and 12 weeks)
- Patient quality of life(Change from baseline at 12 weeks)
- Wound size (wound reduction percentage)(Baseline, 4, 8 and 12 weeks)
- Adverse Events(Change from baseline at 4, 8 and 12 weeks)
- Complete wound healing (Resvech 2.0 score)(Change from baseline at 4, 8 and 12 weeks)
研究者
JOSE MIGUEL MORALES ASENCIO
Head of the Department of Nursing. Professor of Research and Evidence Based Health Care
University of Malaga