Bedside Pulse Lavage Irrigation Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in Gene Expression Analysis
研究概览
简要总结
This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts in chronic wounds.
详细描述
Pulse lavage irrigation is an effective method of cleaning both acute and chronic wounds. The major drawback to pulse irrigation is that it is extremely messy and can easily contaminate the patient's surroundings, putting other patients and the person operating the device at risk. In order to obtain the benefits of pulse lavage, we have created a device that will contain the water spray from the lavage and protect both the patient and their surroundings. Due to the fact that frequent (multiple times daily) pulse lavage therapy has not been possible previously, it is unknown how effectively serial pulse lavage irrigation reduces bacterial counts. This study evaluates the effectiveness of serial pulse lavage therapy in decreasing bacterial counts in chronic wounds.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a chronic wound (as defined by the wound being present for >30 days) located on any part of their body
- •The wound must be smaller than 10cm in greatest diameter.
- •Patients must have an expected remaining hospital duration of 4 days
- •Patients must be willing and able to comply with all study procedures
排除标准
- •Patients must not have undergone any surgical excisions or debridements of the wound in the past 30 days
- •The wound may not undergo any surgical procedures or other treatments other than the study treatments during the course of the study.
- •The wound may not require any immediate surgical intervention or debridement
- •Patients may not start any new antibiotic therapy during the course of the study
- •Must not have an allergy to skin adhesives.
- •Patients must not be taking any immunosuppressive medications.
- •Subjects who, in the opinion of the investigator, may not complete the study for any reason.
结局指标
主要结局
Change in Gene Expression Analysis
时间窗: 4 days
A punch biopsy will be taken at the beginning of the study. this will be sent for gene expression analysis. A repeat biopsy at the end of the study will also be sent at the end of the study, and a change in gene expression in analysis will be evaluated.
Change in Bacterial Counts
时间窗: Baseline and at 4 days
A punch biopsy of the wound will be taken once the subject is enrolled in the study. A repeat biopsy will be taken after the 8th lavage treatment or the 8th dressing change. These will be sent for bacterial count analysis and the difference in bacterial counts will be evaluated. The lavage fluid from baseline measurements will be filtered and sent for bacterial counts and will be compared to the filtered fluid from the last lavage treatment. In addition, surface swabs will be taken at the beginning and end of the study and will be sent for bacterial counts as well. Bacterial counts from these lavage, biopsy specimen, and swabs will be averaged and analyzed.
次要结局
- Pain With Lavage Treatments(4 days)
研究者
Robert Galiano
Assistant Professor of Surgery
Northwestern University