Clinical Study to Comparatively Evaluate the Impact of Drawtex Wound Dressing Against Wound Bioburden in Moderately to Highly Exuding Venous Leg Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To investigate the impact of Drawtex on wound surface bioburden.
研究概览
简要总结
This is a clinical study to comparatively evaluate the impact of Drawtex wound dressing against wound bioburden in moderately to highly exuding venous leg ulcers.
详细描述
Each subject is expected to participate in this study for a period of four weeks or until reepithelialization, whichever occurs first. Subjects may participate for an additional period of four weeks or until reepithelialization, whichever occurs first: this it to be decided by the investigator and will be determined by the accessibility of the patient (physical location) and the suitability of the wound to further treatment. The maximum time period for the study is 8 weeks. The minimum time frame is at least 4 week, or until reepithelialization occurs.
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 weekly office visits at SW Wound Care Center as an out-patient.
- •Subject has a moderately to highly exudative venous leg ulcer that would be indicated for treatment with Drawtex
- •Subject or is informed about the trial, understands its 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 refuses to participate in the study.
- •Subject already participates in the 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'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
To investigate the impact of Drawtex on wound surface bioburden.
时间窗: 2 years
The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers.• The safety of Drawtex will be measured by the number and type of any adverse events. Patient's tolerance and acceptance of the different dressings
次要结局
- Tolerance(2 years)
研究者
Randall Wolcott
Principal Investigator
Southwest Regional Wound Care Center