Clinical trial NCT02753387: Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer
Official title: Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infection
Keywords: mouthwash
head and neck cancer
chlorhexidine
pathogens germs
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: The day of the surgery
Secondary outcomes:
measure: Number of patients with a significant rate of pathogen germs (>=10^2 CFU/ml) at T1
timeFrame: The day of the surgery
measure: Type of oral germs
timeFrame: The day of the surgery
measure: Number of positive cultures of pathogen germs
timeFrame: The day of the surgery
measure: Kinetics of the number of CFU/ml
timeFrame: The day of the surgery
measure: Number of CFU/ml of pathogens germs
timeFrame: The day of the surgery
measure: Surgical site infections rate in the postoperative month (standard definition of the Centers for Disease Control and Prevention, Atlanta)
timeFrame: 30 days
measure: Number of patients who processed correctly preoperative mouthwash
timeFrame: The day of the surgery
measure: Change in the number of CFU/ml of pathogen germs before and after intubation (T2-T3)
timeFrame: The day of the surgery
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Franck JEGOUX, PH
role: PRINCIPAL_INVESTIGATOR
References: