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Completed

NCT Number: NCT02753387

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rennes University Hospital

Rennes, 35033, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine

Drug

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

Other names: Eludril Perio

NaCl 0.9 %

Device

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

Primary outcomes

  1. 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

    Time frame: 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 outcomes

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

    Time frame: 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)

  2. Type of oral germs

    Time frame: 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))

  3. Number of positive cultures of pathogen germs

    Time frame: 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))

  4. Kinetics of the number of CFU/ml

    Time frame: 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))

  5. Number of CFU/ml of pathogens germs

    Time frame: 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))

  6. Surgical site infections rate in the postoperative month (standard definition of the Centers for Disease Control and Prevention, Atlanta)

    Time frame: 30 days

  7. Number of patients who processed correctly preoperative mouthwash

    Time frame: The day of the surgery

  8. Change in the number of CFU/ml of pathogen germs before and after intubation (T2-T3)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: ORAL-ISO

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2016
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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