Efficacy of Prontosan Solution on Chronic Ulcers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 6
- 主要终点
- Reduction of necrotic tissue (Pressure Sore Status Tool-PSST)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution compared with standard isotonic solution on infammation reduction and wound bed cleansing of chronic pressure or vascular leg ulcers.
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
- •Male and females aged at least 18 with Pressure ulcer stage 2-3 NPUAP (National Pressure Ulcer Advisory Panel 1989)or subcutaneous vascular ulcer with inflammation and/or biofilm and/or slough
- •Braden index at baseline>=10
- •Ulcer area<80 cm2
- •Ability to give an informed consent
排除标准
- •Braden index at baseline<10
- •Current therapy with corticosteroids or immunosuppressor or radiotherapy
- •Sensitivity to any of the components of Prontosan® Solution
- •Diabetic foot ulcer
- •Current use of local antiseptics on the wound bed
- •Previous recruitment of another ulcer in the trial
研究组 & 干预措施
Prontosan wound irrigation solution
干预措施: Prontosan wound irrigation solution (Device)
Standard care
干预措施: Isotonic solution (saline or lactated ringer) (Drug)
结局指标
主要结局
Reduction of necrotic tissue (Pressure Sore Status Tool-PSST)
时间窗: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)
Reduction of inflammatory tissue(Pressure Sore Status Tool-PSST)
时间窗: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)
次要结局
- Frequency of wound dressing (clinical score)(From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly))