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

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 5, 2018

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)

Interventions

  • Drug: Chlorhexidine
    • 4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio
  • Device: NaCl 0.9 %
    • 4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %

Arms, Groups and Cohorts

  • Experimental: CHLORHEXIDINE
    • Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine
  • Placebo Comparator: NaCl 0.9 %
    • Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9%

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 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)

Secondary Measures

  • Number of patients with a significant rate of pathogen germs (>=10^2 CFU/ml) at T1
    • Time Frame: The day of the surgery
    • The number of patients with a significant rate of pathogen germs will be determined from the sample collected after mouthwash (T1)
  • Type of oral germs
    • Time Frame: The day of the surgery
    • 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))
  • Number of positive cultures of pathogen germs
    • Time Frame: The day of the surgery
    • 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))
  • Kinetics of the number of CFU/ml
    • Time Frame: The day of the surgery
    • 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))
  • Number of CFU/ml of pathogens germs
    • Time Frame: The day of the surgery
    • 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))
  • Surgical site infections rate in the postoperative month (standard definition of the Centers for Disease Control and Prevention, Atlanta)
    • Time Frame: 30 days
  • Number of patients who processed correctly preoperative mouthwash
    • Time Frame: The day of the surgery
  • Change in the number of CFU/ml of pathogen germs before and after intubation (T2-T3)
    • Time Frame: The day of the surgery
    • The change in the number of CFU/ml of pathogen germs will be assessed using the samples collected before (T2) and after intubation (T3)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rennes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Franck JEGOUX, PH, Principal Investigator, Rennes University Hospital

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