Does Negative Pressure Wound Therapy With Instillation Reduce the Bioburden of Infections of the Upper and Lower Extremity?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement
研究概览
简要总结
The purpose of this study is to compare the microbiologic burden and need for further operative debridement of patients undergoing primary surgical debridement of infected tissue, soft tissue abscesses, or traumatic wounds of the upper and lower extremity.
详细描述
Bacterial bio-burden as measured by quantitative microbial PCR prior to debridement, immediately following initial debridement, after 2 days of VAC veraflo (or conventional VAC) therapy, and at the time of repeat operative debridements, if needed. We will use the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX.) to report on the bacterial burden (reported on a log scale of bacteria per gram) present at the time of debridement. Our goal is to be able to assess the bioburden quantitatively at each time point to discern a change.
Exploratory outcomes to be measured: number of operative debridements required prior to reconstruction, number of days until final reconstruction, number of days until decision is made by surgeon that further debridements are no longer necessary, length of hospital stay, wound surface area will be monitored from enrollment through when the veraflo is removed. This is likely a 3-month interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •18+yo with an injury or infection of the upper or lower extremity for which surgical debridement (in the operating room) followed by VAC application is planned.
排除标准
- •Patient with wounds distal to the ankle.
结局指标
主要结局
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement
时间窗: Day 1 (day of first operative debridement)
Bacterial bio-burden as measured by microbial PCR after debridement using the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX). Reported as the number of participants with low (\< 1x10\^5), medium (1x10\^5 to 1x10\^7), and high (\> 1x10\^7) counts of bacteria per gram.
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement
时间窗: Day 1 (day of first operative debridement)
Bacterial bio-burden as measured by microbial PCR prior to debridement using the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX). Reported as the number of participants with low (\< 1x10\^5), medium (1x10\^5 to 1x10\^7), and high (\> 1x10\^7) counts of bacteria per gram.
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement
时间窗: Day 2 (day of second operative debridement)
Bacterial bio-burden as measured by microbial PCR prior to debridement using the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX). Reported as the number of participants with low (\< 1x10\^5), medium (1x10\^5 to 1x10\^7), and high (\> 1x10\^7) counts of bacteria per gram.
次要结局
未报告次要终点