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

Primary Purpose

Bacterial Infection

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Chlorhexidine
NaCl 0.9 %
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Infection focused on measuring mouthwash, head and neck cancer, chlorhexidine, pathogens germs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • Rennes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CHLORHEXIDINE

NaCl 0.9 %

Arm Description

Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine

Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9%

Outcomes

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 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 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 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 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 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 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)
Number of patients who processed correctly preoperative mouthwash
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)

Full Information

First Posted
April 13, 2016
Last Updated
December 18, 2018
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02753387
Brief Title
Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer
Acronym
ORAL-ISO
Official Title
Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 23, 2016 (Actual)
Primary Completion Date
September 5, 2018 (Actual)
Study Completion Date
September 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection
Keywords
mouthwash, head and neck cancer, chlorhexidine, pathogens germs

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHLORHEXIDINE
Arm Type
Experimental
Arm Description
Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine
Arm Title
NaCl 0.9 %
Arm Type
Placebo Comparator
Arm Description
Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9%
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Other Intervention Name(s)
Eludril Perio
Intervention Description
4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio
Intervention Type
Device
Intervention Name(s)
NaCl 0.9 %
Intervention Description
4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %
Primary Outcome Measure Information:
Title
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
Description
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)
Time Frame
The day of the surgery
Secondary Outcome Measure Information:
Title
Number of patients with a significant rate of pathogen germs (>=10^2 CFU/ml) at T1
Description
The number of patients with a significant rate of pathogen germs will be determined from the sample collected after mouthwash (T1)
Time Frame
The day of the surgery
Title
Type of oral germs
Description
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))
Time Frame
The day of the surgery
Title
Number of positive cultures of pathogen germs
Description
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))
Time Frame
The day of the surgery
Title
Kinetics of the number of CFU/ml
Description
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))
Time Frame
The day of the surgery
Title
Number of CFU/ml of pathogens germs
Description
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))
Time Frame
The day of the surgery
Title
Surgical site infections rate in the postoperative month (standard definition of the Centers for Disease Control and Prevention, Atlanta)
Time Frame
30 days
Title
Number of patients who processed correctly preoperative mouthwash
Time Frame
The day of the surgery
Title
Change in the number of CFU/ml of pathogen germs before and after intubation (T2-T3)
Description
The change in the number of CFU/ml of pathogen germs will be assessed using the samples collected before (T2) and after intubation (T3)
Time Frame
The day of the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck JEGOUX, PH
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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