Role of Post-operative Re-application of Chloraprep® Following Lower Extremity Surgeries on Surgical Site Bacterial Colonization.
试验速览
- 阶段
- 4 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- quantitative bacterial colonization
研究概览
简要总结
The purpose of the current work is to determine the efficacy of the re-application of surgical prep solution in decreasing surgical site bacterial contamination following lower extremity surgery. Decreasing the extent of bacterial colonization of the skin surrounding the surgical site during the initial healing phases would theoretically decrease the rate of infection in high-risk persons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Male and female
- •Adults (18+)
- •Both elective and non-elective procedures
- •Lower extremity surgery performed below the knee and requiring post-operative splint immobilization for 2-3 weeks
- •Able to understand and read the English language
- •Signed informed consent
排除标准
- •Pregnant (to be assessed the day of surgery per standard of care surgical protocol)
- •Known allergies to chlorhexidine gluconate or isopropyl alcohol
- •Multiple planned lower extremity surgeries
- •Local skin disease
- •Pre-existing or known infection at surgical site
- •Open wounds or local abrasions
- •Unable to or unwilling to follow through with study requirements
研究组 & 干预措施
reapplication
This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application.
干预措施: Chloraprep (Drug)
结局指标
主要结局
quantitative bacterial colonization
时间窗: 14-21 days
Compare the number of colony forming units taken from culture swabs immediately adjacent to the wound during dressing change between the two arms
positive culture rate
时间窗: 14-21 days
Compare the overall positive culture rate between the two treatment groups
次要结局
- bacterial strain identification(14-21 days)