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

Bacterial Infection Clinical Trial

— ORAL-ISO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753387
• Other study ID #: 35RC15_8923_ORAL-ISO
• Status: Completed
• Phase: Phase 3
• Start date: May 23, 2016
• Est. completion date: September 5, 2018

Study information

• Verified date: December 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 5, 2018
• Est. primary completion date: September 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Head and Neck Neoplasms

Intervention

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 %

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Surgical site infections rate in the postoperative month (standard definition of the Centers for Disease Control and Prevention, Atlanta)		30 days
Secondary	Number of patients who processed correctly preoperative mouthwash		The day of the surgery
Secondary	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