Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Efficacy in eradicating Staphylococcus aureus (SA)
研究概览
简要总结
The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicating SA carriage compared to other SA decolonization approaches. The study will conduct a single center pilot trial to compare efficacy of different SA decolonization approaches in pre-surgical patients, in eradicating SA carriage, after obtaining informed consent.
The study will compare four different approaches, Arm 1) screen for SA carriage and using the three-drug decolonization bundle for 5 days among patients with SA colonization, non SA carriers in this arm will get two pre-op showers with CHG soap, Arm 2) all participants receive the three drug decolonization bundle, Arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with CHG soap, and Arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with CHG soap.
The primary efficacy outcome will be eradication of SA colonization at all 5 body sites. Secondary outcomes will be SA surgical site infections (SSIs), all SSIs, and SA healthcare associated infections (HAIs). The study will also compare eradication of SA from each of the 5 body sites as a secondary outcome.
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
- •Eligible participanst are outpatients in orthopedic, urology, neuro, otolaryngology, plastic and general surgery and OB/GYN clinics who are scheduled to undergo surgery at participating trial sites.
- •Anticipated surgery ≥ 10 days after the date of enrollment, to allow time for completion of baseline cultures and the decolonization protocol.
- •Age ≥ 18 years
- •Ability to complete the decolonization protocol pre-operatively as an outpatient.
- •No antibiotic therapy at the time of, or seven days prior to, baseline cultures, and no subsequent antibiotic therapy prior to the surgical procedure. Standard pre-op antibiotic prophylaxis given.
- •Patients are having skin incisions as part of their scheduled surgical procedure.
排除标准
- •Inability to give informed consent
- •Surgery anticipated <10 days after the baseline cultures
研究组 & 干预措施
Arm 1a
screening for SA carriage and using the three-drug decolonization bundle among patients with SA colonization
干预措施: Screening and decolonization for SA carriers with the 3 drug bundle (Other)
Arm 1b
non SA carriers in this arm will get two pre-op showers with an antiseptic soap
干预措施: No screening for SA (Other)
Arm 2
giving pre-surgical patients the three drug decolonization bundle without screening.
Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
干预措施: no screening (Other)
Arm 3
giving pre-op nasal povidone iodine without screening
干预措施: Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening. (Other)
Arm 4
giving nasal alcohol gel without screening
干预措施: Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening (Other)
结局指标
主要结局
Efficacy in eradicating Staphylococcus aureus (SA)
时间窗: baseline
The study will compare the efficacy of four different decolonizing approaches and products in eradicating Staphylococcus aureus (SA) before surgery.
次要结局
未报告次要终点