Determining the Impact of Enhanced Daily Disinfection on Environmental Contamination in Acute Care Hospital Rooms: A 3-arm Multicenter Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 475
- 试验地点
- 1
- 主要终点
- Change in total room contamination in study rooms on study day 2
研究概览
简要总结
The purpose of this study is to determine if enhanced daily application of disinfectant with persistent 24-hour activity decreases the environmental bioburden compared to standard practice.
详细描述
The study investigator will evaluate the effectiveness of daily disinfection strategies on environmental contamination in acute care hospital rooms.
The trial will be conducted in acute care hospital rooms at Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, and the University of North Carolina Medical Center. In each study room, one half will be randomized to the control arm, and the other half will be randomized to one of the two intervention arms. Two separate randomization steps will occur. First, each room will be randomized to Intervention 1 or Intervention 2. Second, the half of the room to which the intervention will be applied (e.g., right vs. left) will be randomly selected. The control arm will receive no interventions. Rooms randomized to the control arm will undergo routine disinfection via existing Environmental Services (EVS) protocols. All study hospitals routinely use EPA-registered disinfectants for low-level disinfection of hospital room surfaces. Intervention 1 is the standard EPA-registered disinfectant to each study surface and will be applied by the study team. Intervention 2 is a quaternary ammonium, salt-based, 24-hour continuously active germicidal wipe (Sani-24®) to each study surface and will be applied by the study team.
Three different methods will be used for disinfection. No changes to baseline and routine disinfection practices will occur during the study. EVS employees at study hospitals will be responsible for the total room cleaning and disinfection throughout the study. Tasks will be separated between study team members to maintain blinding.Room contamination will be measured before the application of the interventions on study day 1 and every 24 hours for 3 subsequent days, for a total of 4 days. Secondary outcomes include evaluation for epidemiologically important pathogens (EIP), including me staphylococcus aureus (MRSA or MSSA), extended spectrum beta-lactamase (ESBL) or carbapenem-resistant Enterobacteriaceae (CRE) producing Enterobacterales, vancomycin-resistant Enterococci (VRE), vancomycin-susceptible Enterococci (VSE), Acinetobacter spp., and Pseudomonas aeruginosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Triple blind - exception of the study team member applying the disinfectant products (intervention 1 or 2)
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 patient admitted to the room
- •Patient spent ≥1 night in room prior to enrollment
- •Anticipated patient stay of ≥48 hours
- •On contact precautions (for any reason) and/or has positive culture for EIP at the time of room admission
排除标准
- •Patient stay is expect to be <48 hours
- •Patient age <18, even if on adult ward
- •Patient admitted on respiratory precautions due to coronavirus disease (COVID-19), influenza, or respiratory syncytial virus (RSV)
- •Patient on contact precautions due to C. difficile
研究组 & 干预措施
Sani24
Application of a 24-hour continuously acting quaternary ammonium salt disinfectant: Sani24 (PDI Healthcare Inc.) by study team
干预措施: Sani24 (Other)
Standard EPA-registered disinfectant
Application of standard EPA-registered disinfectant by study team
干预措施: Standard EPA-registered disinfectant (Other)
Control
Routine disinfection completed by hospital staff
干预措施: Routine Disinfection (Other)
结局指标
主要结局
Change in total room contamination in study rooms on study day 2
时间窗: Baseline (day 1), day 2
Total contamination, in colony-forming units (CFUs) on environmental surfaces on study days 1 and 2
次要结局
- Total contamination on room sinks(Day 1, Day 2, Day 3, Day 4)
- Proportion of positive environmental cultures(Day 1, Day 2, Day 3, Day 4)
- Total contamination on room bed rails(Day 1, Day 2, Day 3, Day 4)
- Change in total room contamination(Day 2, Day 3, Day 4)
- Total contamination on room footboards(Day 1, Day 2, Day 3, Day 4)
- Total EIP contamination on room sinks(Day 1, Day 2, Day 3, Day 4)
- Proportion of EIP positive environmental cultures(Day 1, Day 2, Day 3, Day 4)
- Frequency of daily disinfection by EVS or unit personnel (control arm) and study personnel (intervention arms)(Day 2, Day 3, Day 4)
- Total room contamination with epidemiologically important pathogens (EIP)(Day 1, Day 2, Day 3, Day 4)
- Total EIP contamination on room bed rails(Day 1, Day 2, Day 3, Day 4)
- Total EIP contamination on room footboards(Day 1, Day 2, Day 3, Day 4)