Topical Application of Silver Nanoparticles Reduced Oral Pathogens in Mechanically Ventilated Patients: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Compare Colony Forming Units after the intervention. Unique dosis.
研究概览
简要总结
The purpose of this study is to determine whether oral topic silver nanoparticles are effective to reduce potential pathogen microbial loads in mechanical ventilation patients.
详细描述
All patients were performed with oral hygiene as recommended by the clinical practice guidelines for the prevention, diagnosis and treatment of pneumonia associated with mechanical ventilation. After that, placed the treatment of an innocuous gel compound with 12ppm of silver nanoparticles or gel alone according to randomization. Then obtain and plant samples taken before the treatment 6 hours after. Comparing the results of the baseline sample with the final.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least 24 hrs application endotracheal tube and ventilator support were nasogastric tube ,in the ICU of Hospital Central "Dr. Ignacio Morones Prieto"
- •Patients with at least 24 hours of ICU admission.
- •Sedo - analgesia patients in a coma or induced coma.
- •Over 15 years old
- •Informed consent signed by a family member or legal guardian of the patient.
排除标准
- •The patient is not taking part in another study that cause conflict with the present test.
- •Patients who develop bronchiectasis , severe or massive hemoptysis , cystic fibrosis.
- •Patients with known sensitivity to silver.
- •Patients who had reported difficult intubation in the record.
- •Patients whose physical condition does not allow the completion of the oral examination, proper sampling or application of gel.
- •Pregnant women
- •Patients with oral mucositis
研究组 & 干预措施
placebo
topic innocuous gel
干预措施: placebo (Other)
gel silver nanoparticles
topic gel silver nanoparticles 12 ppm
干预措施: silver nanoparticles (Other)
结局指标
主要结局
Compare Colony Forming Units after the intervention. Unique dosis.
时间窗: Comparison of microbial colony forming units at 6 hr of treatment with gel application
Before oral hygiene in the intubated patient, it was taken with sterile swab, a saliva sample which was sown in dextrose Sabouraud agar and tryptone soya agar. 6 hours later, placement of the experimental gel, retook saliva sample with a sterile swab and they seeded in the same agars . Colony forming units were counted before and after the intervention using semi-automated colony counter .
次要结局
未报告次要终点
研究者
Francisco Javier Tejeda Nava
Dental Surgeon, Oral Pathology and Medicine, Clinical Profesor
Universidad Autonoma de San Luis Potosí