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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Bacterial Infection

Intervention / Treatment
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* Drug: Chlorhexidine
* Device: NaCl 0.9 %


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHLORHEXIDINE<br>Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine | Drug: Chlorhexidine<br>* 4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio<br>* Other names: Eludril Perio;|
| Placebo Comparator: NaCl 0.9 %<br>Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9% | Device: NaCl 0.9 %<br>* 4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | The day of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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)) | 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)) | 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)) | The day of the surgery | 
| Number of CFU/ml of pathogens germs | The number of CFU/ml of pathogens 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)) | 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 | 
| Change in the number of CFU/ml of pathogen germs before and after intubation (T2-T3) | The change in the number of CFU/ml of pathogen germs will be assessed using the samples collected before (T2) and after intubation (T3) | The day of the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mouthwash, head and neck cancer, chlorhexidine, pathogens germs