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

NCT ID: NCT02753387

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-23

Study Completion Date

2018-09-05

Brief Summary

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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

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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)

Conditions

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Bacterial Infection

Keywords

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mouthwash head and neck cancer chlorhexidine pathogens germs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CHLORHEXIDINE

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

Group Type EXPERIMENTAL

Chlorhexidine

Intervention Type DRUG

4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio

NaCl 0.9 %

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

Group Type PLACEBO_COMPARATOR

NaCl 0.9 %

Intervention Type DEVICE

4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %

Interventions

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Chlorhexidine

4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio

Intervention Type DRUG

NaCl 0.9 %

4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %

Intervention Type DEVICE

Other Intervention Names

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Eludril Perio

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franck JEGOUX, PH

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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Rennes University Hospital

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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35RC15_8923_ORAL-ISO

Identifier Type: -

Identifier Source: org_study_id