A Prospective, Randomized Controlled Trial Comparing 2 Propanol plus Benzalkonium Chloride versus Povidone Iodine for the Prevention of Surgical Site Infections
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- Incidence of SSI within 30 days post-surgery, defined by CDC criteria.
研究概览
简要总结
Surgical site infections (SSIs) are among the most common complications after surgery, leading to prolonged hospital stay, higher costs, and increased patient suffering. Preoperative skin antisepsis is a key step in preventing these infections. In India, povidone-iodine is widely used, but international guidelines now recommend alcohol-based antiseptics for faster and longer-lasting protection. This study will compare the effectiveness of an alcohol-based antiseptic (2-propanol with benzalkonium chloride) against povidone-iodine in reducing surgical site infections.
We will include 434 adult patients undergoing clean or clean-contaminated elective surgeries at AIIMS Raipur. Patients will be randomly assigned to receive either the alcohol-based antiseptic or povidone-iodine before surgery. All other aspects of surgery and post-operative care will remain the same. The main outcome will be the occurrence of surgical site infection within 30 days after surgery. The findings may help develop locally relevant antiseptic guidelines and improve infection control practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •(18 years, clean/clean-contaminated elective surgeries, ASA I–III).
排除标准
- •(allergy, emergency surgery, immunocompromised, pregnancy/lactation, neonates).
结局指标
主要结局
Incidence of SSI within 30 days post-surgery, defined by CDC criteria.
时间窗: Incidence of surgical site infection at postoperative day 7, day 14, day 30.
次要结局
- Time to onset of SSI(From day of surgery to postoperative day 30.)
- Classification of SSI(Time Point: Day 7, Day 14, Day 30.)
- Local skin reactions(Day 0, Day 1, Day 7, Day 14.)
- Adverse events(Day 0 to Day 30.)
- Cost-effectiveness(At end of follow-up (Day 30).)
研究者
Dr Sameer Uttamrao Khasbage
AIIMS, RAIPUR