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

Sponsor

Rennes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02753387

Collaborator

(none)

Enrollment

Location

Arms

27.4

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infection	Drug: Chlorhexidine Device: NaCl 0.9 %	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 23, 2016

Actual Primary Completion Date :

Sep 5, 2018

Actual Study Completion Date :

Sep 5, 2018

Arms and Interventions

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 %

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 %

Outcome Measures

Primary Outcome 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 [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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