A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Bacterial Diversity and Number of Bacteria Present in the Wound
研究概览
简要总结
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
详细描述
The primary aim of this pilot study is to investigate differences in bacterial content of the study wound that may impact upon infection rates following debridement with the WoundWand Debridement Device or Standard of Care (SoC) surgical (sharp) debridement. Additionally, the clinical investigation will evaluate reduction in wound size post-debridement and gather Health Economic data relating to wound bed debridement with the WoundWand Debridement Device or SoC.
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
- Single (Participant)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Bacterial Diversity and Number of Bacteria Present in the Wound
时间窗: Day 1 (immediately pre- and post-debridement) and 4 weeks post-debridement
Primary endpoint was to determine bacterial diversity and number of bacteria present in the study wound at 4 weeks post- debridement using either WoundWand Debridement Device or Standard of Care. Punch biopsies were performed per standard practice to quantify the type and amount of bacteria present in wounds debrided with either Standard of Care Sharp Debridement or WoundWand Debridement Device. Debridement of contaminated tissue is essential to prevent wound infection, promote healing, and provide a neat wound edge for the prevention of scaring. A 3-4 mm punch biopsy for quantitative tissue culture (i.e. bacterial content) will be collected from the study wound site immediately pre- and post-debridement and at Week 4. The punch biopsy will be performed per standard practice and if required, utilizing the appropriate analgesia \[e.g. general, local (e.g. 1% lidocaine with epinephrine)\]. Quantitative tissue culture will be completed according to the laboratory's standard procedures
次要结局
- Photograph Area Measurements to Determine Reduction in Wound Size(Visit 2 through Visit 8 (12 weeks))
- Wound Status Using Bates-Jensen Wound Assessment - Total Score(Screening through Visit 8 (12 weeks))
- Braden Scale for Predicting Pressure Sore Risk - Total Score(Screening through Visit 8 (12 weeks))
