Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer (ORAL-ISO)

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 Overview

• Status: Completed
• Conditions: Bacterial Infection
• Intervention / Treatment: Drug: Chlorhexidine; Device: NaCl 0.9 %

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)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CHLORHEXIDINE; Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine	Drug: Chlorhexidine; 4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio; Other Names: Eludril Perio
PLACEBO_COMPARATOR: NaCl 0.9 %; Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9%	Device: NaCl 0.9 %; 4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Franck JEGOUX, PH, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 23, 2016
• Primary Completion (ACTUAL): September 5, 2018
• Study Completion (ACTUAL): September 5, 2018

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (ESTIMATE): April 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: head and neck cancer; chlorhexidine; mouthwash; pathogens germs
• Additional Relevant MeSH Terms: Infections; Neoplasms; Neoplasms by Site; Bacterial Infections and Mycoses; Head and Neck Neoplasms; Bacterial Infections; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 35RC15_8923_ORAL-ISO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO