Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- bacterial count (CFU/cm2)
研究概览
简要总结
The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.
详细描述
The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative scrubbing methods during nail avulsion surgery. The investigators compared intraoperative antiseptic scrubbing using 0.9% saline solution and 0.1% polihexanide. Swab samples were taken from each patient at 5 distinct stages throughout the surgical procedure, and bacterial culture analysis was performed (positive culture rate, total inocula count, reduction of bacterial load, and identification of specific microorganisms).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18
- •Onychocryptosis
排除标准
- •infection
- •a history of tinea pedis
- •onychomycosis
- •paronychia
- •nail trauma or subungual hematoma
- •nail deformities and disorders
- •peripheral vascular disease or diabetes
- •cardiac disease
- •a history of rheumatic fever
- •recent antibiotic use or current antimicrobial therapy
- •a history of steroid use and
- •recent nail polish use
研究组 & 干预措施
Sterile Saline solution
The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
干预措施: Polihexanide (Drug)
结局指标
主要结局
bacterial count (CFU/cm2)
时间窗: Participants will be followed until the surgery to heal completely,an expected average of 7 weeks
The percentage of inoculum reduction at the irrigation step was calculated as follows: percentage of inoculum reduction = 100 e (1003 Ii)/Is, where Ii is the bacterial count (CFU/cm2) at the irrigation step and Is is the inoculum (CFU/cm2) at the surgery step. Bacteria were identified using standard laboratory methods. The limit of detection in the nailfold test was 1.33 CFU/cm2.
次要结局
未报告次要终点