Randomised, Controlled, Clinical Trial on the Safety and Efficacy of Prontosan Wound Irrigation Solution Compared to Standard Therapy in the Treatment of Hard-to-Heal Venous Leg Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reduction of bacterial burden (quantitative bacteriology) Reduction in slough and necrotic tissue (clinical score) Amount and quality of granulation tissue (clinical score) Exudate type and amount (clinical score)
研究概览
简要总结
Objective:
To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution
Methodology:
Randomised, controlled multi-centre, prospective clinical trial
Planned number of subjects:
20 patients in experimental group (Prontosan® Wound Irrigation Solution) 8 patients in control group (wound irrigation with saline)
Products under investigation:
Prontosan® Wound Irrigation Solution
Study Duration:
3-4 weeks
详细描述
Investigational product, dose and administration:
Prontosan® Wound Irrigation Solution (experimental group) and saline solution (control group) will be applied at inclusion and reapplied after dressing changes.
The treatment scheme is as follows:
- Prontosan® Wound Irrigation Solution (experimental group):
- cleansing the wound bed at dressing change with Prontosan® Wound Irrigation Solution; a sterile gauze dressing impregnated with the Prontosan® solution will be placed on the immediate wound in the form of a moist compress and removed after approximately 15 minutes;
- placing the primary dressing (Profore® WCL): the dressing will be impregnated with Prontosan® Wound Irrigation Solution;
- fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system).
- Saline (control group):
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
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females aged at least 18 with wounds of venous aetiology (documented by targeted exams) located in the lower limbs
- •Ankle Brachial Index (ABI) ≥ 0.7
- •patients who have not had an antimicrobial (systemic antibiotic or topical antiseptic) over the 30 days before joining the study
排除标准
- •Exclusion criteria
- •age below 18 years
- •presence of clinical infection, or current use of antiseptics or antibiotics
- •chronic wounds of long duration (>30cm2 and >1 year duration)
- •involvement in other wound related trials within the past 30 days
- •sensitivity to any of the components of Prontosan® or dressing material
- •intolerance to compression therapy
- •active osteomyelitis in the ulceration area
- •active rheumatoid arthritis (RA) requiring any immunosuppressive therapy
- •collagen vascular disease active treated with steroids
- •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
- •both, controlled and uncontrolled diabetics (type 1 or 2)
- •patients on any rheological agents (not including aspirin)
结局指标
主要结局
Reduction of bacterial burden (quantitative bacteriology) Reduction in slough and necrotic tissue (clinical score) Amount and quality of granulation tissue (clinical score) Exudate type and amount (clinical score)
时间窗: weekly
次要结局
- Adverse device effect (s) Adverse events(volunteered at any time or during weekly evaluation visits)