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

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)

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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 %