Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer

Rennes University Hospital80 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Bacterial Infection

Interventions

ChlorhexidineDRUG

4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio

NaCl 0.9 %DEVICE

4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rennes University Hospital

Rennes, France

Outcomes

Primary Outcomes

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

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)

Time frame: The day of the surgery

Secondary Outcomes

Number of patients with a significant rate of pathogen germs (>=10^2 CFU/ml) at T1

The number of patients with a significant rate of pathogen germs will be determined from the sample collected after mouthwash (T1)

Time frame: The day of the surgery

Type of oral germs

The type of germs will be determined for all the samples collected during the surgery (i.e. 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))

Time frame: The day of the surgery

Number of positive cultures of pathogen germs

The number of positive cultures of pathogen germs will be determined for all the samples collected during the surgery (i.e. 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))

Time frame: The day of the surgery

Kinetics of the number of CFU/ml

The kinetics of the number of CFU/ml will be determined from all the samples collected during the surgery (i.e. 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))

Data from ClinicalTrials.gov

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