Number of Necessary Paints of Preoperative Skin Disinfection to Prevent Surgical Site Infections; PAINTS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Change in microbial skin counts (number of Colony forming Units (CFU))
研究概览
简要总结
This observational study investigates whether 3 paints are superior compared to 2 paints in reducing microbial skin counts in the disinfection area of cardiac and abdominal surgery patients.
详细描述
Surgical site infection (SSI) remain the most common nosocomial infection in surgical departments. Preparation of the skin with disinfectants belongs to the standard of care prior to any surgical intervention but disinfection practices are heterogeneous across different hospitals and countries. Although the efficacy and effectiveness of preoperative surgical site preparation is dependent on both the antiseptic agent used and the application method, it is unclear how many paints of an antiseptic are needed to ensure adequate infection protection.
An adequately powered study including different standard antiseptic agents (i.e. chlorhexidine in alcohol (CHX) and povidone iodine in alcohol (PI)) is therefore required to compare the protective effect of different numbers of paints.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients undergoing elective cardiac surgery at the study site
- •Adult patients undergoing elective abdominal surgery at the study site
- •Provision of informed consent
排除标准
- •Pregnancy reported by patient
- •Emergency (non-elective) surgical interventions
- •Contraindications to the use of either one of the compounds: Alcoholic CHX; Alcoholic PI
- •Skin or other hypersensitivity reactions during the disinfection process
结局指标
主要结局
Change in microbial skin counts (number of Colony forming Units (CFU))
时间窗: prior to skin disinfection (T0) and after paint two (T1, approx. after 2 minutes) and after paint three (T2; approx. after 3 minutes) before start of surgery
Change in microbial skin counts (CFU) after 3 paints as compared to 2 paints
次要结局
- Proportion of patients with insufficient reduction of microbial skin counts (i.e. log reduction of CFU <2) after 2 paints(after paint two (T1, approx. after 2 minutes))
- Proportion of patients with microbial skin counts of 0 CFU after 3 paints as compared to 2 paints(after paint two (T1, approx. after 2 minutes) and after paint three (T2; approx. after 3 minutes) before start of surgery)