Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of patients with pharyngeal mucosa colonization (>=10^2 Colony Forming Unit (CFU)/ml of pathogen germs of the oral flora) at the end of the surgery
研究概览
简要总结
Surgical site infections are an important health indicator for hospitals and a significant medico-economic issue.
The aim of the study is to assess the impact of chlorhexidine mouthwash performed before surgery on the bacterial colonization of the pharyngeal mucosa.
详细描述
The main objective is to reduce the number of patients with significant pathogenic bacterial colonization for pharyngeal mucosa at the end of the surgery. Oral flora is the same as the pharyngeal flora, so this suggests that the action of the oral mouthwash may also act in pharyngeal mucosa by buccopharyngeal communication.
Patients will be randomized into two groups :
- preoperative oral preparation with sodium chloride (NaCl) 0.9% (control group)
- preoperative oral preparation with chlorhexidine (experimental group)
A quantitative and qualitative analysis will be performed from samples collected during the surgery : before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5)
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
- 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
- •Histological evidence of cancer regardless of histological type
- •Surgical treatment requiring mucosal effraction regardless of the surgical approach;
- •Patient over 18 years old;
- •Oral cancer, oropharyngeal cancer, hypopharyngeal cancer or laryngeal cancer;
- •Written and informed patient consent
排除标准
- •Concomitant Vascular Interventions;
- •Interventional radiology;
- •Needing of second surgery at a same location during the 30 postoperative days);
- •Cancer of the paranasal sinus, nasal cavity, skull base, salivary glands, skin,
- •Neck dissection without mucosal effraction
- •Thyroid or parathyroid surgery
- •Size tumor forbidden tumor surgery
- •Allergy to any tested product;
- •Concurrent infection the day before or day of surgery
- •Protected adults (guardianship) and persons deprived of liberty
研究组 & 干预措施
CHLORHEXIDINE
Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine
干预措施: Chlorhexidine (Drug)
NaCl 0.9 %
Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9%
干预措施: NaCl 0.9 % (Device)
结局指标
主要结局
Percentage of patients with pharyngeal mucosa colonization (>=10^2 Colony Forming Unit (CFU)/ml of pathogen germs of the oral flora) at the end of the surgery
时间窗: The day of the surgery
The percentage of patients with pharyngeal mucosa colonization will be determined from the sample collected on the mucosal scar just before the end of the surgery (T5)
次要结局
- Type of oral germs(The day of the surgery)
- Number of positive cultures of pathogen germs(The day of the surgery)
- Kinetics of the number of CFU/ml(The day of the surgery)
- Change in the number of CFU/ml of pathogen germs before and after intubation (T2-T3)(The day of the surgery)
- Number of patients with a significant rate of pathogen germs (>=10^2 CFU/ml) at T1(The day of the surgery)
- Number of CFU/ml of pathogens germs(The day of the surgery)
- Surgical site infections rate in the postoperative month (standard definition of the Centers for Disease Control and Prevention, Atlanta)(30 days)
- Number of patients who processed correctly preoperative mouthwash(The day of the surgery)