Clinical Study of Evaluate the Effect of Sorbion Sachet S Wound Dressing on Soft Tissue Edema and Wound Bioburden in Moderately to Highly Exuding Pressure Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- The primary objective of this study is to investigate the effect of sachet S reduction on local soft tissue edema (excessive interstitial fluid to a maximum 3cm depth) in pressure ulcers.
研究概览
简要总结
This is a clinical study to evaluate the effects of sorbion sachet s wound dressing on soft tissue edema and wound bioburden in moderately to highly exuding pressure ulcers.
详细描述
This study is aimed at the participation of subject with moderately to highly exuding pressure ulcers. Each Subject is expected to participate for a period of 4 weeks or until reepithelization, which occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject > 18 years.
- •Subject is attending SW Wound Care Center
- •Subject has a wound not smaller than 1cm2
- •Subject has a wound not larger than 14cm X 23cm
- •Subject has a moderately to highly exudative pressure ulcer that would be indicated for treatment with sorbion sachet S
- •Subject or subject's legally authorized representative is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrollment.
- •Subject is willing and able to comply with all specified care and visit requirements.
排除标准
- •Subject has a lesion that does not meet the inclusion criteria.
- •Subject has a pressure ulcer that contains areas of undermined tissue.
- •Subject refuses to participate in the study.
- •Subject is participating in another clinical study.
- •Subject already participates in this study with one wound (only one wound per subject is allowed)
- •Subject has known sensitivity to the trial product or any of its compounds.
- •Subject is expected to be non-compliant.
- •Subject uses therapy known to be immunocompromising such as systemic anti cancer drugs and/or systemic corticosteroids.
- •Subject suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS.
- •Subject's lesion is a primary skin cancer.
- •Subject's lesion is the manifestation of a metastasis.
- •Subject is pregnant.
结局指标
主要结局
The primary objective of this study is to investigate the effect of sachet S reduction on local soft tissue edema (excessive interstitial fluid to a maximum 3cm depth) in pressure ulcers.
时间窗: 1 year
To investigate the effect of sachet S reduction on local soft tissue edema in pressure ulcers and the degree to which sachet S influences the wound surface bioburden qualitatively and quantitatively.
次要结局
- The secondary objectives are to further investigate whether sorbion sachet s(1 year)