Risk of Contamination by COVID-19 During Oral Care With Aerosolization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Evaluate the risk of skin and mucous membrane contamination of practitioners during oral care performed on patients diagnosed with COVID +.
研究概览
简要总结
The sudden Covid-19 pandemic has led all healthcare workers to adapt to an unprecedented situation by continuing to provide care while protecting themselves and their patients. Medical care with aerosolization systems is particularly of risk because of the strong propagation of the droplets they generate, especially during oral care. Considering the high risk of transmission of the SARS-CoV-2 virus in dental structures remain essential and still very challenging. The need to put in place care procedures to protect the nursing staff and patients is definitely more than necessary. Dental protection equipments against this emergent virus have progressively integrated daily practice, but, to the knowledge of the investigators, no study has precisely evaluated their efficiency.
The main objective of this study is to estimate the risk of dental practitioners to be contaminated by SARS-CoV-2 during dental procedures with or without aerosolization procedures.
For this, after their informed consent, vaccinated dental practitioners or practitioners with a positive covid serological tests of the dental department of Charles Foix hospital will receive individually forty to fifty COVID+ patients. COVID + patients will be included a maximum of one week after the diagnosis of the pathology. Patient care will be determined and performed according to standard practice as part of their standard management and without interference with the study. The usual measures to protect caregivers. The included patients will undergo an oral dental procedure either with aerosolisation or not. Then, SARS-CoV 2 samples will be collected using viral swabs on different spots, followed by detection and quantification by PCR. Swabbing will be achieved on:
- The facial skin, nasal, ocular and oral mucosa of the practitioners.
- The protection equipment of the practitioners (FFP2 masks, visors,surgical calot,gloves) .
- The environment (dental Chair, surgical light, turbine, contra-angle, on the ground..) The presence of viral loads in areas used by COVID + patients will be evaluated by PCR after swabbing.
The study will provide insight into the risk of SARS-CoV 2 contamination for practitioners performing dental procedures in COVID + patients. This risk will be assessed at the level of the facial skin and oral mucous membranes, which are the doors of entry of the virus.
This study will thus make it possible to assess the protective capacity of the protection protocol implemented in investigators' department in this epidemic situation. This will be assessed depending on whether or not aerosolization is used, its type and the nature of the ventilation in the operating room.
详细描述
Introduction The outbreak of severe acute respiratory syndrome with coronavirus 2 (SARS-CoV 2) in Wuhan, China, in December 2019, quickly turned into a global pandemic (12 March 2020, WHO) leading most countries to take exceptional health measures. Indeed, in the absence of a proven treatment against COVID-19, the preventive approach aimed at reducing the risk of transmission; containment, barrier measures, has been put forward in many countries.
In this context, healthcare workers are in the front line of SARS-CoV 2 and present a high risk of contamination. Among them, dentists have been identified as the health professionals most at risk of contamination by SARS-CoV2. Indeed, SARS-CoV2 is transmitted, directly or indirectly, by respiratory secretions via airborne particles called aerosols. The virus can thus be detected in secretions from the nasopharynx but also in saliva.
For the specialities covering the ENT sphere, the main routes of contamination are blood, saliva droplets and direct contact with the patient. For SARS-CoV 2, its high contagiousness adds to the risk factors related to the proximity of the oral cavity of patients during care. Contact with nebulisers such as ultrasound (used for scaling), turbines or contra-angles (used for tooth and jawbone milling) contribute to aerosol and splash formation. Aerosols remain suspended in the air for several minutes, and can therefore increase the risk of SARS-CoV2 infection. Aerosols from an infected patient can increase the risk of infection for ENT professionals and the risk of spreading the virus to other patients.
For example, oral health care has been reduced to emergencies only in many countries. The same is true in France where the recommendations of the ARS and the Order of Dental Surgeons have followed the same objectives .
Globally, the only available studies on dental care during COVID have reviewed the organisation and procedures in place in dental departments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •COVID + patients
- •Over the age of 18
- •Tested positively a maximum of one week before inclusion
- •Requiring oral care
- •Affiliates or beneficiaries of Social Security • Informed and not opposed to participating in the research
- •Practitioners
- •Age under 65
- •Absence of comorbidity (hypertension, obesity, diabetes)
- •Informed and not opposed to participating in the research
排除标准
- •COVID + patients
- •State of health incompatible with oral care.
- •Patient under guardianship / curators
- •Pregnant or breastfeeding patients
- •Pregnant / breastfeeding woman
结局指标
主要结局
Evaluate the risk of skin and mucous membrane contamination of practitioners during oral care performed on patients diagnosed with COVID +.
时间窗: 6 months after the beginning of the study
Percentage of odontological procedures leading to the detection of SARS-CoV 2 on the face (skin surface and facial mucous membranes) of practitioners performing procedures on COVID + patients
次要结局
- Evaluate the risk of contamination of practitioners, PPE and surfaces depending on the type of aerosolization used (contra-angle, ultrasonic scaler)(6 months after the beginning of the study)
- Determine the presence of SARS-CoV 2 on personal protective equipment (PPE) depending on whether: • the procedure involves aerosolization (contra-angle, ultrasonic scaler),(6 months after the beginning of the study)
- Determine the presence of SARS-CoV 2 on the face and facial mucous membranes of practitioners after the dental procedure depending on whether: • the procedure does not involve aerosolization (intraoral examination, intraoral X-ray, biopsy)(6 months after the beginning of the study)
- Evaluate the presence of viral loads in areas used by COVID + patients(6 months after the beginning of the study)
- Determine the presence of SARS-CoV 2 on the face and facial mucous membranes of practitioners after the dental procedure depending on whether: • the procedure involves aerosolization (turbine, ultrasonic scaler,…),(6 months after the beginning of the study)