Self-contamination Following Removal of Two Personal Protective Equipment Suits: a Randomized, Controlled, Crossover Simulation Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mean within-participant difference in self-contamination between PPE-G and PPE-C suits
研究概览
简要总结
Anesthesiologists and other professionals are at high risk of viral infection during aerosol-generating procedures. Knowledge of the protective quality of PPE suits and the risk of self-contamination after removal is paramount. This trial used an ultraviolet-fluorescent solution to explore differences in self-contamination after removal of gown PPE (PPE-G) and coverall PPE (PPE-C). A two-period/two-intervention (AB/BA) design was chosen; each intervention consisted of audio-guided placement of PPE, full-body spraying of fluorescent solution, audio-guided removal of PPE, and assessment of self-contamination through ultraviolet light scanning. The primary outcome was the mean within-participant difference (traces of any size) between PPE suits. Statistical significance was tested using t test for paired data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
In a specific area, the blinded outcome assessor (researcher #2) performed standardized scanning of participants' skin and base clothing using ultraviolet light in a dark room, revealing the presence of any fluorescent traces. The seven body zones assessed were face, anterior and posterior neck, arms, hands, clothing (anterior/posterior, upper, and lower clothing), and foot covers. Fluorescent traces were measured (small traces, ≤1 cm; large traces, >1 cm) and quantified for statistical analyses.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anesthesiology Department member (Hospital Italiano de Buenos Aires, Buenos Aires, Argentina), participation in the PPE training workshop.
排除标准
- •Refusal to participate in the study
- •Known allergy to any of the components of the fluorescent lotion
结局指标
主要结局
Mean within-participant difference in self-contamination between PPE-G and PPE-C suits
时间窗: 20 minutes
Mean difference between paired observations (number of fluorescent traces, any size, any body zone, per PPE suit) from each participant.
次要结局
- Correlation between self-contamination and adherence to the PPE removal protocol(5 minutes)
研究者
DELFINA SANCHEZ NOVAS
Physician
Hospital Italiano de Buenos Aires