Pilot, Randomised, Double-blind, Controlled Clinical Trial on the Combined Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel in the Reduction in Size and Change in Bioburden of Hard-to-heal Venous Leg Ulcers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Absolute Change of Target Ulcer From Baseline to Last Visit
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared to control saline irrigation solution and inactive gel by showing a reduction in size over a 12 week period.
详细描述
SUMMARY
Sponsor: B. BRAUN Medical AG
Trade name: Prontosan® Wound Irrigation Solution Prontosan® Wound Gel
Active substance: Polihexanide (0.1%) Betaine (0.1%)
Study Duration (per patient):
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
- Triple (Participant, Care Provider, Investigator)
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
- •Males and females aged > 18 who are able to give informed consent
- •Patients with a chronic venous leg ulcer at any location below the knee joint (CVI grade C6 according to CEAP classification = trophic lesions and open ulcer)
- •Venous leg ulcer present for ≥4 weeks
- •Surface area of the target ulcer ≥2cm2 and <100cm2 with the largest length not being >10cm
- •ABPI ≥ 0.7
排除标准
- •Age below 18 years
- •Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study
- •Pregnant or breast feeding women
- •Signs and symptoms of clinical infection, or current use of antiseptics or antibiotics
- •Involvement in other trials within the past 1 month
- •Sensitivity to any of the components of Prontosan® or dressing material
- •Intolerance to compression therapy
- •Active osteomyelitis in the ulceration area
- •Active rheumatoid or collagen disease of blood vessels treated with corticosteroids
- •Chronic diseases that could impact the course of the study (malicious cancer, TB, AIDS, mental illnesses)
- •Plasma protein below 4 g/dl
- •Anaemia: haemoglobin below 10 g/dl
- •Poorly controlled Diabetes (HBA1C > 12%)
研究组 & 干预措施
Prontosan Wound Solution and Gel
Cleansing the wound bed, a sterile gauze dressing impregnated with the Prontosan® or saline solution, removed after 15 minutes; wound will be sparingly covered with Prontosan® Wound Gel or inactive gel. Secondary dressing to be a semi occlusive dressing. Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day)
干预措施: Prontosan Wound Irrigation Solution and Prontosan Wound Gel (Device)
Normal Saline and Placebo Gel
Cleansing the wound bed, a sterile gauze dressing impregnated with the Prontosan® or saline solution, removed after 15 minutes; wound will be sparingly covered with Prontosan® Wound Gel or inactive gel. Secondary dressing to be a semi occlusive dressing. Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day)
干预措施: Normal Saline and Placebo Gel (Device)
结局指标
主要结局
Absolute Change of Target Ulcer From Baseline to Last Visit
时间窗: 12 weeks
Percent Change of Wound Size From Baseline to Last Visit
时间窗: 12 Weeks
Healing of Target Ulcer atV6/EOS
时间窗: 12 weeks
Number of ulcers healed at V6/EOS
次要结局
- Number of Different Microganisms at V6/EoS(12 Weeks)
- Pain(12 Weeks)
- Condition of Wound Bed(12 Weeks)