The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Bacterial Bioburden
研究概览
简要总结
This prospective clinical trial will compare the bacterial burden in the wound bed and on the periwound skin before and after mechanical debridement with EZ Debride using fluorescence imaging.
After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MLiX). The ulcer is mechanically debridement with the EZ Debride device after which a second MLiX procedure is performed. The investigator will then compare the two images.
详细描述
Acute and chronic wounds burden healthcare systems across the globe. In the United States the cost of nonhealing wounds approximates 100 billion dollars.1-3 The presence of bacteria in and around the wound impedes wound healing. Clinicians treat elevated wound bacterial levels with mechanical and sharp debridement, topical antiseptics and systemic antibiotics. However, evidence on the best methods to reduce bacterial load is lacking. The EZ-1 clinical trial will utilize the latest fluorescence imaging technology to investigate whether mechanical debridement using the EZ Debride® tool reduces bacterial burden.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with acute or chronic wounds that have been present for a minimum of 4 weeks.
- •A signed and dated informed consent form.
- •Subject is willing and able to comply with instructions and scheduled visits.
排除标准
- •The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety.
- •The subject's wound has not been present for at least 4 weeks.
结局指标
主要结局
Change in Bacterial Bioburden
时间窗: Before and After Mechanical debridement within 1 hour
The reduction in bacterial bioburden following mechanical wound debridement as determined by the MolecuLight Procedure (MLiX).
次要结局
- Pain Score(Before, during, and after mechanical debridement within 1 hour)
- Adverse Events(During debridement)