A Prospective Single-blind Placebo-controlled Trial to Establish the Efficacy and Tolerability of 10% Povidone-Iodine for Nasal S. Aureus and Methicillin Resistant S. Aureus (MRSA) Decolonization Among Patients Undergoing Same-day Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen.
研究概览
简要总结
To evaluate the efficacy and tolerability of 10% povidone-iodine in eliminating nasal carriage of Staphylococcus aureus and MRSA. To determine whether a more convenient, single-dose, pre-operative 10% povidone-iodine (PI) application is effective in reducing nasal carriage of S. aureus and MRSA. We expect a statistically significant decrease in S. aureus/MRSA colonization in nasal cultures taken perioperatively after intervention in patients who received pretreatment with PI as compared to patients who received normal saline (NS).
详细描述
This will be a prospective single-blinded randomized placebo-controlled trial of two applications of a nasal 10% Povidone Iodine (PI) solution used on the intranasal mucosal surfaces of each nostril in the preoperative holding area within 2 h prior to surgical incision compared with NS using the same technique. Both the PI and NS will be applied by rotating the swab over the intranasal mucosal surface for 15 seconds; this process will be performed twice for both nostrils, using a new swab for each application. Nasal cultures will be obtained prior to PI or NS application as well as intraoperatively 1 hour and 2 hours after first surgical incision. The primary study end point is the decrease in S. aureus/MRSA colony forming units (CFU) in nasal cultures taken within 2 hours after intervention in patients who presented with a positive preintervention nasal culture. A secondary endpoint is the presence or absence of surgical site infections within 30 days postoperatively
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
- Single (Outcomes Assessor)
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
- •community-based patients ages 18-80
- •American Society of Anesthesiology (ASA) 1-3
- •undergoing an outpatient surgery for at least 1 hour and up to 6 hours duration
排除标准
- •pregnancy
- •allergy to povidone-iodine
- •infectious indication for surgery or preexisting known infection/wound
- •immunocompromised state
- •use of chemotherapy or steroids within 30 days prior to surgery
- •use of antimicrobial therapy within 30 days prior to surgery
- •surgeries where field avoidance prevents intraoperative access to the nares
研究组 & 干预措施
treatment
Application of Povidone-Iodine 10% prior to surgery to Nares
干预措施: Povidone-Iodine 10% (Drug)
placebo
Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
干预措施: 0.9% NaCl Solution (Drug)
结局指标
主要结局
Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen.
时间窗: 1, 2, and 3 hours after application of Povidone-Iodine or saline solution
The difference in a number of S. aureus/MRSA CFU in nasal swab specimens between before and after the study drug/placebo application in patients with a positive for S. aureus/MRSA pre-interventional nasal swab specimen. The change (Δ) is calculated as the value at the baseline time point minus the value at the later time point. Positive values represent a decrease in CFU, whereas negative values represent an increase in CFU.
次要结局
- Surgical Site Infections(at 7 and 30-day postoperative intervals)
研究者
Dennis Grech, MD
Associate Professor
Rutgers, The State University of New Jersey