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

R

Rennes University Hospital

Status and phase

Completed
Phase 3

Conditions

Bacterial Infection

Treatments

Drug: Chlorhexidine
Device: NaCl 0.9 %

Study type

Interventional

Funder types

Other

Identifiers

NCT02753387
35RC15_8923_ORAL-ISO

Details and patient eligibility

About

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.

Full 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)

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups, including a placebo group

CHLORHEXIDINE
Experimental group
Description:
Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine
Treatment:
Drug: Chlorhexidine
NaCl 0.9 %
Placebo Comparator group
Description:
Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9%
Treatment:
Device: NaCl 0.9 %

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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